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#191 | The Costly Mistake Of Separating Regulatory Decisions From Commercial Strategy For MedTech Exporting (For Clinicans) · Clinician to CEO : Export Your Medical Device With Confidence By Overcoming Go To Market Roadblocks For Medtech Growth

• 0:00
  in
• 0:00
  this
• 0:00
  episode,
• 0:00
  you'll
• 0:01
  find
• 0:01
  out
• 0:01
  how
• 0:01
  to
• 0:01
  align
• 0:02
  your
• 0:02
  regulatory
• 0:03
  path
• 0:03
  with
• 0:03
  your
• 0:03
  commercial
• 0:04
  strategy
• 0:05
  for
• 0:05
  increased
• 0:06
  healthcare
• 0:07
  adoption.
• 0:07
  Welcome
• 0:08
  to
• 0:08
  Clinician
• 0:08
  to
• 0:09
  CEO,
• 0:10
  the
• 0:10
  podcast
• 0:10
  helping
• 0:11
  clinicians
• 0:12
  simplify
• 0:12
  your
• 0:12
  go-to-market
• 0:13
  strategy
• 0:14
  so
• 0:14
  that
• 0:14
  you
• 0:14
  can
• 0:14
  stop
• 0:15
  guessing
• 0:15
  and
• 0:16
  turn
• 0:16
  your
• 0:16
  working
• 0:17
  prototypes
• 0:17
  into
• 0:18
  international
• 0:18
  MedTech
• 0:19
  businesses.
• 0:20
  I'm
• 0:20
  your
• 0:20
  host,
• 0:20
  Hakeem
• 0:21
  Aade.
• 0:22
  Let's
• 0:22
  get
• 0:22
  started.
• 0:23
  Today
• 0:24
  we're
• 0:24
  gonna
• 0:24
  be
• 0:24
  talking
• 0:25
  about
• 0:25
  the
• 0:25
  dangers
• 0:26
  of
• 0:26
  focusing
• 0:27
  solely
• 0:27
  on
• 0:28
  a
• 0:28
  regulatory
• 0:28
  compliance
• 0:29
  at
• 0:29
  the
• 0:29
  expense
• 0:30
  of
• 0:30
  commercial
• 0:30
  strategy,
• 0:31
  and
• 0:31
  to
• 0:32
  help
• 0:32
  me
• 0:32
  in
• 0:32
  that
• 0:32
  endeavor.
• 0:33
  And
• 0:33
  in
• 0:33
  that
• 0:33
  discussion,
• 0:34
  I'm
• 0:34
  joined
• 0:34
  by
• 0:35
  Kadi
• 0:35
  Badal,
• 0:36
  who
• 0:36
  is
• 0:36
  founder
• 0:36
  of
• 0:37
  QRA
• 0:38
  Medical,
• 0:38
  which
• 0:39
  are
• 0:39
  the
• 0:39
  quality
• 0:39
  and
• 0:39
  a
• 0:39
  regulatory
• 0:40
  affairs
• 0:41
  consultancy.
• 0:41
  Welcome.
• 0:42
  To
• 0:42
  the
• 0:42
  show.
• 0:43
  Karen
• 0:43
  Deep
• 0:43
  thank
• 0:44
  you
• 0:44
  Mi
• 0:44
  Hakeem.
• 0:45
  How
• 0:45
  are
• 0:45
  you
• 0:45
  today?
• 0:45
  I'm
• 0:46
  very,
• 0:46
  very
• 0:46
  well,
• 0:46
  thank
• 0:47
  you
• 0:47
  very
• 0:47
  much.
• 0:47
  And,
• 0:47
  looking
• 0:48
  forward
• 0:48
  to
• 0:49
  a
• 0:49
  discussion.
• 0:50
  And
• 0:50
  the
• 0:50
  three
• 0:50
  things
• 0:51
  that
• 0:51
  hopefully
• 0:51
  we're
• 0:51
  gonna
• 0:51
  be
• 0:52
  getting
• 0:52
  get
• 0:52
  through
• 0:52
  today
• 0:52
  and,,
• 0:53
  our
• 0:53
  listeners
• 0:53
  will,
• 0:54
  learn
• 0:54
  and
• 0:55
  discover.
• 0:55
  The
• 0:55
  first
• 0:56
  one
• 0:56
  is
• 0:56
  why
• 0:56
  regulatory
• 0:57
  approval?
• 0:57
  Alone
• 0:58
  doesn't
• 0:58
  lead
• 0:59
  to
• 0:59
  revenue.
• 0:59
  Number
• 0:59
  two,
• 1:00
  where
• 1:00
  most
• 1:00
  med
• 1:01
  tech
• 1:01
  founders
• 1:01
  go
• 1:01
  wrong
• 1:02
  after
• 1:02
  being
• 1:02
  approved,
• 1:03
  and
• 1:03
  or
• 1:03
  getting
• 1:03
  their
• 1:03
  products
• 1:04
  approved.
• 1:04
  And
• 1:04
  number
• 1:04
  three,
• 1:05
  how
• 1:05
  to
• 1:05
  build
• 1:06
  a
• 1:06
  commercial
• 1:06
  strategy
• 1:07
  alongside
• 1:08
  your
• 1:08
  regulatory
• 1:09
  path.
• 1:09
  So
• 1:09
  hopefully
• 1:10
  you've
• 1:10
  come
• 1:10
  ready
• 1:11
  to
• 1:11
  discuss
• 1:11
  that.
• 1:12
  'cause
• 1:12
  I've
• 1:12
  worked
• 1:13
  with
• 1:13
  Kandy.
• 1:13
  And
• 1:13
  he
• 1:13
  is
• 1:13
  been
• 1:14
  on
• 1:14
  the
• 1:14
  podcast
• 1:14
  before,
• 1:15
  so,
• 1:15
  I'm
• 1:15
  hoping
• 1:15
  you'll
• 1:16
  enjoy
• 1:16
  his
• 1:17
  commercial
• 1:17
  look
• 1:18
  at
• 1:18
  regulatory
• 1:18
  rather
• 1:19
  than
• 1:19
  his
• 1:19
  regulatory
• 1:19
  look
• 1:20
  at
• 1:20
  regulatory,
• 1:21
  if
• 1:21
  that
• 1:21
  makes
• 1:21
  sense.
• 1:22
  so
• 1:22
  we're
• 1:22
  gonna,
• 1:23
  we're
• 1:23
  gonna
• 1:23
  dive
• 1:23
  straight
• 1:24
  in.
• 1:24
  and
• 1:24
  I
• 1:24
  suppose
• 1:24
  the
• 1:24
  first
• 1:25
  question
• 1:25
  I
• 1:25
  always,
• 1:26
  I'll
• 1:26
  ask
• 1:26
  is
• 1:27
  how
• 1:27
  do
• 1:27
  he
• 1:27
  define,
• 1:28
  because
• 1:28
  I'm
• 1:28
  talking
• 1:28
  about
• 1:28
  balance,
• 1:29
  how
• 1:29
  do
• 1:29
  you
• 1:29
  define
• 1:30
  what
• 1:30
  that
• 1:30
  balance
• 1:31
  between
• 1:32
  regulatory
• 1:32
  compliance
• 1:33
  and
• 1:33
  commercial
• 1:34
  strategy
• 1:35
  should
• 1:35
  be
• 1:35
  in
• 1:35
  med
• 1:35
  tech?
• 1:36
  Yeah,
• 1:36
  that's
• 1:36
  a
• 1:36
  good
• 1:36
  point.
• 1:37
  You
• 1:37
  bring
• 1:37
  up
• 1:37
  Hakeem,
• 1:37
  because
• 1:38
  a
• 1:38
  lot
• 1:38
  of
• 1:38
  people
• 1:38
  under
• 1:39
  the
• 1:39
  impression
• 1:39
  that
• 1:39
  sort
• 1:40
  of
• 1:40
  regulatory
• 1:40
  is
• 1:40
  a
• 1:40
  bit
• 1:40
  of
• 1:41
  a
• 1:41
  hindrance
• 1:41
  to
• 1:41
  commercial.
• 1:42
  But
• 1:42
  my
• 1:43
  view
• 1:43
  on
• 1:43
  it
• 1:43
  is
• 1:44
  that
• 1:44
  only
• 1:44
  happens
• 1:44
  when
• 1:45
  you
• 1:45
  start
• 1:45
  to
• 1:45
  see
• 1:45
  them
• 1:45
  as
• 1:45
  two
• 1:46
  separate
• 1:46
  work
• 1:46
  streams.
• 1:47
  It's
• 1:47
  very
• 1:47
  important
• 1:48
  that
• 1:48
  you
• 1:48
  understand
• 1:48
  that
• 1:48
  sort
• 1:49
  of
• 1:49
  regulatory
• 1:50
  and
• 1:50
  sort
• 1:50
  of
• 1:50
  commercial
• 1:51
  work
• 1:51
  hand
• 1:51
  in
• 1:51
  hand
• 1:51
  together.
• 1:52
  So
• 1:52
  think
• 1:52
  of
• 1:52
  it
• 1:52
  like
• 1:53
  this
• 1:53
  in
• 1:53
  a
• 1:53
  sense,
• 1:53
  is
• 1:54
  that
• 1:54
  regulatory
• 1:54
  decisions
• 1:55
  are
• 1:55
  basically
• 1:56
  commercial
• 1:56
  decisions,
• 1:57
  but
• 1:57
  wearing
• 1:57
  regulatory
• 1:58
  clothing,
• 1:58
  things
• 1:58
  like
• 1:58
  your
• 1:59
  intended
• 1:59
  use,
• 1:59
  your
• 2:00
  predicate,
• 2:00
  if
• 2:00
  you're
• 2:01
  going
• 2:01
  for
• 2:01
  the
• 2:01
  US
• 2:01
  claims
• 2:02
  classification.
• 2:03
  All
• 2:03
  of
• 2:03
  them
• 2:03
  basically
• 2:04
  shape
• 2:04
  what
• 2:04
  you
• 2:05
  can
• 2:05
  sell,
• 2:05
  who
• 2:05
  you
• 2:06
  can
• 2:06
  sell
• 2:06
  it
• 2:06
  to,
• 2:06
  and
• 2:07
  what
• 2:07
  the
• 2:07
  margin
• 2:07
  is.
• 2:08
  So
• 2:08
  the
• 2:08
  key
• 2:08
  word
• 2:08
  here
• 2:09
  is
• 2:09
  all
• 2:09
  about
• 2:10
  balance.
• 2:10
  A
• 2:10
  good
• 2:11
  regulatory
• 2:11
  strategy
• 2:12
  also
• 2:12
  works
• 2:13
  very
• 2:13
  well
• 2:13
  with
• 2:13
  a
• 2:14
  commercial
• 2:14
  strategy.
• 2:15
  So
• 2:15
  consider
• 2:15
  them
• 2:15
  to
• 2:15
  be
• 2:16
  one
• 2:16
  work
• 2:16
  stream
• 2:17
  that
• 2:17
  works
• 2:17
  hand
• 2:17
  in
• 2:17
  hand
• 2:17
  together
• 2:18
  rather
• 2:18
  than
• 2:18
  two
• 2:18
  separate
• 2:19
  work
• 2:19
  streams.
• 2:19
  And
• 2:20
  that's
• 2:20
  a
• 2:20
  really
• 2:20
  important
• 2:21
  point.
• 2:21
  And
• 2:21
  actually
• 2:22
  it's
• 2:22
  probably,
• 2:22
  one
• 2:23
  of
• 2:23
  the,
• 2:23
  of
• 2:23
  most
• 2:24
  businesses
• 2:25
  in
• 2:25
  the,
• 2:25
  they
• 2:26
  look
• 2:26
  at
• 2:26
  every
• 2:27
  department
• 2:27
  as
• 2:27
  slightly
• 2:28
  separate
• 2:28
  in
• 2:29
  terms
• 2:29
  of,
• 2:29
  if
• 2:29
  you
• 2:29
  look
• 2:29
  at
• 2:29
  sales
• 2:30
  and
• 2:30
  marketing,
• 2:30
  they're
• 2:31
  two
• 2:31
  sides
• 2:31
  of
• 2:31
  the
• 2:31
  same
• 2:32
  coin,
• 2:32
  but
• 2:32
  everyone
• 2:32
  has
• 2:32
  different
• 2:33
  departments.
• 2:33
  If
• 2:33
  you
• 2:33
  look
• 2:33
  at
• 2:34
  regulatory,
• 2:34
  if
• 2:34
  you
• 2:34
  look
• 2:34
  at
• 2:34
  operations,
• 2:35
  but
• 2:35
  what
• 2:36
  you're
• 2:36
  saying
• 2:36
  is
• 2:36
  actually,
• 2:37
  specifically
• 2:38
  when
• 2:38
  we're
• 2:38
  talking
• 2:38
  about
• 2:39
  regulatory,
• 2:39
  is
• 2:40
  that
• 2:40
  you
• 2:40
  should
• 2:40
  be
• 2:41
  consuming
• 2:41
  it
• 2:42
  as
• 2:42
  part
• 2:42
  of
• 2:42
  the
• 2:42
  commercial
• 2:43
  strategy
• 2:43
  and
• 2:43
  the
• 2:43
  commercial
• 2:44
  strategy
• 2:44
  as
• 2:44
  part
• 2:44
  of
• 2:44
  the
• 2:45
  regulatory
• 2:45
  strategy,
• 2:46
  really.
• 2:46
  And
• 2:46
  it's
• 2:46
  just
• 2:47
  different
• 2:48
  emphasis
• 2:48
  on
• 2:49
  those.
• 2:49
  So
• 2:50
  why
• 2:50
  do
• 2:50
  you
• 2:51
  think.
• 2:51
  That
• 2:51
  it's
• 2:51
  a
• 2:52
  rarity
• 2:52
  in
• 2:53
  the
• 2:53
  MedTech
• 2:53
  game
• 2:54
  then,
• 2:54
  because
• 2:54
  I've
• 2:54
  not,
• 2:55
  I
• 2:55
  mean,
• 2:55
  unless
• 2:55
  you've
• 2:55
  seen
• 2:56
  what
• 2:56
  you're
• 2:56
  discussing
• 2:57
  regularly,
• 2:58
  I
• 2:58
  don't.
• 2:58
  I
• 2:58
  always
• 2:59
  seen
• 2:59
  people's
• 3:00
  identifying
• 3:00
  'em
• 3:01
  as
• 3:01
  two
• 3:01
  separate
• 3:01
  things
• 3:01
  and
• 3:01
  then
• 3:02
  commercial
• 3:02
  over
• 3:02
  here
• 3:03
  and
• 3:03
  regulatory
• 3:04
  over
• 3:04
  there.
• 3:04
  I
• 3:04
  think
• 3:04
  it's
• 3:05
  quite
• 3:05
  common.
• 3:05
  Hakeem
• 3:06
  is
• 3:06
  more
• 3:06
  so
• 3:06
  when
• 3:06
  companies
• 3:07
  are
• 3:07
  new
• 3:07
  to
• 3:07
  this,
• 3:08
  particularly
• 3:08
  in
• 3:08
  the
• 3:08
  startup
• 3:08
  space
• 3:09
  where
• 3:09
  they
• 3:09
  just
• 3:09
  go.
• 3:10
  Like
• 3:10
  with
• 3:10
  any
• 3:10
  other
• 3:10
  industry,
• 3:11
  let's
• 3:11
  say
• 3:11
  something
• 3:11
  like
• 3:12
  consumer
• 3:12
  electronics
• 3:13
  where
• 3:13
  you
• 3:13
  can
• 3:13
  just
• 3:13
  make
• 3:13
  something
• 3:14
  and
• 3:14
  it's
• 3:14
  on
• 3:14
  a
• 3:14
  shelf
• 3:14
  in
• 3:14
  a
• 3:14
  couple
• 3:15
  of
• 3:15
  days
• 3:15
  time
• 3:15
  and
• 3:15
  you
• 3:15
  can
• 3:15
  just
• 3:16
  start
• 3:16
  selling
• 3:16
  it.
• 3:16
  So
• 3:17
  when
• 3:17
  companies
• 3:17
  are
• 3:18
  quite
• 3:18
  new
• 3:18
  to
• 3:18
  the
• 3:18
  regulatory
• 3:19
  space
• 3:19
  within
• 3:19
  medical
• 3:20
  devices,
• 3:20
  they
• 3:20
  have
• 3:21
  that
• 3:21
  mindset
• 3:21
  of
• 3:21
  let's
• 3:22
  get
• 3:22
  the
• 3:22
  minimum
• 3:22
  viable
• 3:22
  product
• 3:23
  and
• 3:23
  stick
• 3:23
  it
• 3:23
  out
• 3:23
  there,
• 3:24
  which
• 3:24
  does
• 3:24
  work
• 3:24
  in
• 3:24
  under
• 3:25
  industries,
• 3:25
  but
• 3:25
  that
• 3:26
  doesn't
• 3:26
  work
• 3:26
  here.
• 3:26
  Now,
• 3:27
  the
• 3:27
  companies
• 3:27
  of
• 3:27
  which
• 3:28
  have
• 3:28
  been
• 3:28
  around
• 3:28
  in
• 3:29
  this
• 3:29
  for
• 3:29
  a
• 3:29
  few
• 3:29
  years,
• 3:30
  or
• 3:30
  maybe
• 3:30
  if
• 3:30
  you've
• 3:30
  got
• 3:30
  a
• 3:30
  C
• 3:30
  or
• 3:31
  a
• 3:31
  founder
• 3:31
  who's
• 3:31
  been
• 3:31
  in
• 3:31
  this
• 3:31
  industry
• 3:32
  before.
• 3:32
  They
• 3:33
  understand
• 3:33
  the
• 3:33
  importance
• 3:34
  of
• 3:34
  regulatory.
• 3:35
  I
• 3:35
  think
• 3:35
  what
• 3:35
  it
• 3:35
  is
• 3:35
  just
• 3:36
  a
• 3:36
  case
• 3:36
  here,
• 3:36
  is
• 3:36
  there's
• 3:37
  a
• 3:37
  lot
• 3:37
  of
• 3:37
  sort
• 3:37
  of
• 3:37
  tech
• 3:37
  companies
• 3:38
  that
• 3:38
  move
• 3:38
  kind
• 3:38
  of
• 3:39
  quickly
• 3:39
  and
• 3:39
  they
• 3:39
  may
• 3:39
  have
• 3:39
  stumbled
• 3:40
  upon
• 3:40
  healthcare
• 3:40
  and
• 3:40
  then
• 3:41
  tried
• 3:41
  to
• 3:41
  create
• 3:41
  a
• 3:41
  medical
• 3:42
  device
• 3:42
  and
• 3:42
  then
• 3:42
  still
• 3:43
  have
• 3:43
  that
• 3:43
  mindset
• 3:43
  of
• 3:43
  let's
• 3:44
  just
• 3:44
  put
• 3:44
  the
• 3:44
  product
• 3:45
  out
• 3:45
  there.
• 3:45
  Or
• 3:45
  in
• 3:45
  some
• 3:46
  cases,
• 3:46
  they
• 3:46
  don't
• 3:47
  realize
• 3:47
  they're
• 3:47
  making
• 3:47
  a
• 3:47
  medical
• 3:48
  device,
• 3:48
  and
• 3:48
  that's
• 3:48
  quite
• 3:49
  notorious
• 3:49
  in
• 3:49
  the
• 3:50
  software
• 3:50
  as
• 3:50
  a
• 3:50
  medical
• 3:50
  device
• 3:51
  space
• 3:51
  where
• 3:51
  they
• 3:51
  start
• 3:52
  making
• 3:52
  healthcare
• 3:52
  claims.
• 3:53
  Let's
• 3:53
  say.
• 3:53
  There
• 3:53
  could
• 3:53
  be
• 3:54
  something
• 3:54
  like
• 3:54
  a
• 3:54
  physiotherapy
• 3:55
  app
• 3:55
  where
• 3:55
  they
• 3:55
  just
• 3:56
  see
• 3:56
  it
• 3:56
  as
• 3:56
  a
• 3:56
  bit
• 3:56
  of
• 3:56
  exercise,
• 3:57
  but
• 3:57
  due
• 3:57
  to
• 3:57
  the
• 3:57
  claims
• 3:58
  that
• 3:58
  they're
• 3:58
  making
• 3:59
  and
• 3:59
  saying
• 3:59
  that
• 3:59
  it
• 3:59
  could
• 3:59
  potentially
• 4:00
  help
• 4:00
  heal
• 4:00
  you
• 4:01
  certain
• 4:01
  conditions
• 4:01
  or
• 4:02
  a
• 4:02
  disability
• 4:02
  you
• 4:02
  may
• 4:02
  have,
• 4:03
  you're
• 4:03
  in
• 4:03
  the
• 4:03
  medical
• 4:03
  device
• 4:04
  territory.
• 4:04
  So
• 4:04
  at
• 4:05
  this
• 4:05
  point,
• 4:05
  they've
• 4:05
  already
• 4:05
  created
• 4:06
  the
• 4:06
  product.
• 4:06
  They've
• 4:06
  got
• 4:06
  an
• 4:07
  unrealistic
• 4:07
  timeline
• 4:08
  of
• 4:08
  saying
• 4:08
  something
• 4:08
  like,
• 4:08
  look,
• 4:08
  we
• 4:09
  wanna
• 4:09
  launch
• 4:09
  this
• 4:09
  in
• 4:09
  three
• 4:10
  months
• 4:10
  time.
• 4:10
  Then
• 4:10
  they
• 4:10
  just
• 4:11
  realize
• 4:11
  that
• 4:11
  they're
• 4:11
  now
• 4:11
  a
• 4:11
  regulated
• 4:12
  medical
• 4:12
  device.
• 4:13
  So
• 4:13
  they
• 4:13
  kind
• 4:13
  of
• 4:13
  have
• 4:13
  to
• 4:13
  go
• 4:14
  back
• 4:14
  to
• 4:14
  the
• 4:14
  drawing
• 4:14
  board,
• 4:15
  redo
• 4:15
  their
• 4:15
  intended
• 4:16
  use
• 4:16
  statement,
• 4:16
  build
• 4:16
  on
• 4:17
  an
• 4:17
  extra
• 4:17
  team.
• 4:17
  So
• 4:18
  I
• 4:18
  think
• 4:18
  it's
• 4:18
  just
• 4:18
  a
• 4:18
  case
• 4:19
  of,
• 4:19
  it's
• 4:19
  a
• 4:19
  mixture
• 4:19
  of
• 4:20
  misunderstanding
• 4:20
  and
• 4:20
  people
• 4:21
  coming
• 4:21
  from
• 4:21
  different
• 4:21
  industries
• 4:22
  and
• 4:22
  first
• 4:23
  timers
• 4:23
  in
• 4:23
  this
• 4:23
  industry.
• 4:24
  Okay.
• 4:24
  Yeah,
• 4:24
  no,
• 4:24
  I
• 4:24
  think
• 4:24
  that's
• 4:25
  a
• 4:25
  good
• 4:25
  point.
• 4:25
  'cause
• 4:25
  yeah,
• 4:26
  most
• 4:26
  of
• 4:26
  the
• 4:26
  times
• 4:27
  when
• 4:27
  I've
• 4:27
  seen
• 4:27
  it
• 4:27
  not
• 4:28
  work
• 4:28
  that
• 4:28
  great
• 4:29
  is
• 4:29
  when
• 4:29
  it
• 4:29
  is,
• 4:30
  a
• 4:30
  startup
• 4:31
  or
• 4:31
  something
• 4:31
  of
• 4:31
  that
• 4:31
  nature,
• 4:32
  whereby
• 4:32
  actually,
• 4:33
  generally
• 4:33
  they,
• 4:34
  it's
• 4:34
  almost
• 4:34
  the
• 4:35
  opposite.
• 4:35
  'cause
• 4:35
  what
• 4:35
  you're
• 4:36
  talking
• 4:36
  about
• 4:36
  when
• 4:36
  you're
• 4:36
  talking
• 4:36
  about
• 4:36
  software
• 4:37
  in
• 4:37
  healthcare
• 4:38
  they're
• 4:38
  almost
• 4:39
  going
• 4:39
  to
• 4:39
  commercial
• 4:39
  before
• 4:40
  they
• 4:40
  go
• 4:40
  to
• 4:40
  regulatory.
• 4:41
  And
• 4:41
  then
• 4:41
  they
• 4:41
  realize,
• 4:42
  oh,
• 4:42
  there's
• 4:42
  lots
• 4:42
  of
• 4:42
  regulatory.
• 4:43
  hurdles
• 4:43
  that
• 4:43
  they
• 4:43
  need
• 4:44
  to
• 4:44
  understand
• 4:45
  and
• 4:45
  then
• 4:45
  overcome.
• 4:45
  But
• 4:46
  then
• 4:46
  on
• 4:46
  the
• 4:46
  other
• 4:46
  side,
• 4:47
  you've
• 4:47
  got
• 4:47
  devices
• 4:48
  where
• 4:48
  people
• 4:49
  tend
• 4:49
  to
• 4:49
  spend
• 4:50
  a
• 4:50
  lot
• 4:50
  of
• 4:50
  time,
• 4:51
  getting
• 4:51
  all
• 4:51
  the
• 4:51
  regulatory
• 4:52
  ducks
• 4:52
  in
• 4:52
  a
• 4:52
  row
• 4:52
  and
• 4:53
  then
• 4:53
  they
• 4:53
  get
• 4:53
  excited
• 4:54
  'cause
• 4:54
  they've
• 4:54
  got
• 4:55
  FDA
• 4:55
  approval
• 4:56
  or
• 4:56
  they've
• 4:56
  got
• 4:56
  MDR
• 4:57
  or
• 4:57
  whatever
• 4:58
  else
• 4:58
  it
• 4:58
  may
• 4:58
  be.
• 4:59
  And
• 4:59
  a
• 5:00
  c
• 5:00
  mark,
• 5:00
  et
• 5:00
  cetera.
• 5:01
  And
• 5:01
  then
• 5:02
  they
• 5:02
  think,
• 5:02
  oh,
• 5:02
  well,
• 5:02
  we've
• 5:03
  got
• 5:03
  it.
• 5:03
  And
• 5:03
  then
• 5:03
  they
• 5:03
  start,
• 5:04
  start
• 5:04
  wondering
• 5:04
  three
• 5:04
  months,
• 5:05
  four
• 5:05
  months,
• 5:05
  five
• 5:05
  months
• 5:06
  after,
• 5:06
  why
• 5:06
  not
• 5:06
  getting
• 5:06
  any
• 5:06
  revenues
• 5:07
  because
• 5:07
  they've
• 5:08
  not
• 5:08
  actually
• 5:08
  thought
• 5:08
  of
• 5:08
  a
• 5:08
  commercial
• 5:09
  plan.
• 5:10
  From
• 5:10
  your
• 5:10
  point
• 5:10
  of
• 5:10
  view,
• 5:10
  what's
• 5:11
  the
• 5:11
  most
• 5:11
  common
• 5:11
  pitfalls
• 5:12
  that
• 5:12
  you
• 5:12
  see
• 5:13
  founders
• 5:13
  specifically,
• 5:14
  or
• 5:14
  startups
• 5:15
  faced
• 5:16
  regarding
• 5:16
  regulations
• 5:18
  and
• 5:18
  market
• 5:18
  readiness
• 5:19
  in
• 5:19
  terms
• 5:19
  of
• 5:20
  bringing
• 5:20
  those
• 5:20
  two
• 5:20
  together
• 5:21
  at
• 5:21
  the
• 5:21
  same
• 5:21
  time?
• 5:22
  Sure.
• 5:22
  So
• 5:22
  one
• 5:23
  that
• 5:23
  I
• 5:23
  can
• 5:23
  see
• 5:23
  is
• 5:24
  a
• 5:24
  regulatory
• 5:24
  approval
• 5:25
  doesn't
• 5:25
  automatically
• 5:26
  mean
• 5:26
  that
• 5:26
  your
• 5:26
  product's
• 5:26
  gonna
• 5:27
  sell.
• 5:27
  So
• 5:27
  just
• 5:27
  because
• 5:28
  you've
• 5:28
  got
• 5:28
  that
• 5:28
  five
• 5:28
  10
• 5:29
  K
• 5:29
  or
• 5:29
  the
• 5:29
  de
• 5:29
  novo
• 5:30
  or
• 5:30
  that
• 5:30
  CE
• 5:30
  market
• 5:30
  means
• 5:31
  you're
• 5:31
  allowed
• 5:31
  to
• 5:31
  legally
• 5:32
  sell
• 5:32
  it,
• 5:32
  but
• 5:32
  doesn't
• 5:32
  necessarily
• 5:33
  mean
• 5:33
  that
• 5:33
  there's
• 5:33
  a
• 5:33
  market
• 5:34
  at
• 5:34
  the
• 5:34
  end
• 5:34
  of
• 5:34
  it.
• 5:34
  So
• 5:34
  some
• 5:35
  companies
• 5:35
  chase
• 5:36
  that
• 5:36
  regulatory
• 5:36
  approval,
• 5:37
  and
• 5:37
  that's
• 5:37
  the
• 5:37
  worst
• 5:37
  scenario
• 5:38
  to
• 5:38
  be
• 5:38
  in,
• 5:38
  and
• 5:38
  then
• 5:38
  realize
• 5:39
  that
• 5:39
  there's
• 5:39
  no
• 5:39
  market
• 5:40
  there
• 5:40
  for
• 5:40
  you.
• 5:40
  I
• 5:40
  think
• 5:40
  that's
• 5:41
  sort
• 5:41
  of
• 5:41
  one
• 5:41
  of
• 5:41
  the
• 5:41
  pitfalls.
• 5:42
  Another
• 5:42
  one,
• 5:42
  of
• 5:42
  course,
• 5:43
  is
• 5:43
  treating
• 5:44
  regulatory
• 5:45
  as
• 5:45
  a
• 5:45
  downstream
• 5:46
  gate
• 5:46
  rather
• 5:46
  than
• 5:47
  as
• 5:47
  an
• 5:47
  upstream
• 5:48
  commercial
• 5:48
  lever.
• 5:48
  If
• 5:49
  you
• 5:49
  do
• 5:49
  regulatory
• 5:50
  properly,
• 5:50
  it
• 5:50
  can
• 5:51
  benefit
• 5:51
  you
• 5:51
  from
• 5:51
  a
• 5:51
  commercial
• 5:52
  perspective,
• 5:52
  but
• 5:53
  if
• 5:53
  you
• 5:53
  try
• 5:53
  to
• 5:53
  keep
• 5:53
  the
• 5:53
  two
• 5:54
  separated
• 5:54
  and
• 5:54
  they're
• 5:54
  not
• 5:55
  speaking
• 5:55
  to
• 5:55
  one
• 5:55
  another,
• 5:56
  that's
• 5:56
  immediately
• 5:56
  where
• 5:56
  you
• 5:56
  start
• 5:57
  entering
• 5:57
  problems.
• 5:58
  Just
• 5:58
  before
• 5:58
  you
• 5:58
  go
• 5:58
  on
• 5:59
  there,
• 5:59
  sorry,
• 5:59
  just,
• 5:59
  I
• 5:59
  wanna
• 6:00
  make
• 6:00
  sure
• 6:00
  that
• 6:00
  everyone's
• 6:01
  clear
• 6:01
  with
• 6:01
  where
• 6:01
  we
• 6:01
  are.
• 6:02
  So
• 6:02
  when
• 6:02
  you
• 6:02
  talk
• 6:02
  about
• 6:02
  downstream
• 6:03
  and
• 6:03
  upstream,
• 6:03
  just
• 6:04
  can
• 6:04
  you
• 6:04
  just
• 6:04
  explain
• 6:05
  that
• 6:05
  for
• 6:05
  the
• 6:05
  listeners
• 6:06
  to
• 6:06
  make
• 6:06
  sure
• 6:06
  that
• 6:06
  they're
• 6:07
  on
• 6:07
  the
• 6:07
  same
• 6:07
  page
• 6:08
  with
• 6:08
  us?
• 6:08
  Sure.
• 6:09
  So
• 6:09
  basically
• 6:09
  what
• 6:09
  I
• 6:09
  mean
• 6:10
  by
• 6:10
  downstream
• 6:10
  is
• 6:11
  this
• 6:11
  is
• 6:11
  they
• 6:11
  make
• 6:12
  a
• 6:12
  decision
• 6:12
  first
• 6:12
  and
• 6:12
  then
• 6:13
  it
• 6:13
  trickles
• 6:13
  down
• 6:13
  into
• 6:13
  regulatory.
• 6:14
  Whereas
• 6:14
  realities
• 6:15
  regulatory
• 6:15
  should
• 6:16
  be
• 6:16
  at
• 6:16
  the
• 6:16
  top,
• 6:16
  see
• 6:16
  what
• 6:17
  LA
• 6:17
  claims
• 6:18
  you
• 6:18
  can
• 6:18
  legally
• 6:18
  make,
• 6:19
  and
• 6:19
  then
• 6:19
  that
• 6:19
  should
• 6:19
  form
• 6:20
  as
• 6:20
  a
• 6:20
  downstream,
• 6:20
  okay?
• 6:20
  What
• 6:21
  many
• 6:21
  of
• 6:21
  the
• 6:21
  companies
• 6:21
  are
• 6:21
  doing
• 6:22
  saying,
• 6:22
  look,
• 6:22
  we
• 6:22
  want
• 6:22
  the
• 6:22
  product
• 6:23
  to
• 6:23
  be
• 6:23
  this
• 6:23
  regulatory,
• 6:24
  go
• 6:24
  and
• 6:24
  do
• 6:24
  it.
• 6:24
  Rather
• 6:25
  than
• 6:25
  speak
• 6:25
  into
• 6:26
  regulatory
• 6:26
  and
• 6:26
  saying,
• 6:26
  okay,
• 6:27
  which
• 6:27
  of
• 6:27
  these
• 6:27
  claims
• 6:28
  are
• 6:28
  possible?
• 6:28
  Which
• 6:29
  one
• 6:29
  of
• 6:29
  these
• 6:29
  are
• 6:29
  feasible
• 6:30
  and
• 6:30
  which
• 6:30
  ones
• 6:30
  are
• 6:30
  we
• 6:30
  allowed
• 6:30
  to
• 6:31
  make?
• 6:31
  If
• 6:31
  that
• 6:31
  decision
• 6:32
  is
• 6:32
  made
• 6:32
  on
• 6:32
  the
• 6:32
  sort
• 6:33
  of
• 6:33
  upstream,
• 6:33
  then
• 6:33
  that's
• 6:34
  a
• 6:34
  better
• 6:34
  way
• 6:34
  of
• 6:34
  doing
• 6:34
  it.
• 6:34
  Okay.
• 6:35
  Yeah.
• 6:35
  Perfect.
• 6:35
  So
• 6:36
  In
• 6:36
  terms
• 6:37
  of,
• 6:37
  in
• 6:37
  the
• 6:38
  companies
• 6:38
  that
• 6:38
  you've
• 6:38
  worked
• 6:39
  with,
• 6:39
  et
• 6:39
  cetera,
• 6:40
  and
• 6:40
  I
• 6:40
  mean
• 6:40
  you're
• 6:40
  predominantly
• 6:41
  regulatory,
• 6:41
  so
• 6:41
  do
• 6:42
  you
• 6:42
  go
• 6:42
  in
• 6:42
  and
• 6:42
  have
• 6:42
  these
• 6:43
  conversations
• 6:43
  with
• 6:43
  companies
• 6:44
  around
• 6:44
  them
• 6:45
  understanding
• 6:46
  that
• 6:46
  it's
• 6:46
  one
• 6:46
  work
• 6:47
  stream
• 6:47
  or
• 6:47
  are
• 6:47
  you
• 6:48
  pay
• 6:48
  commissions
• 6:49
  that
• 6:49
  just
• 6:49
  go
• 6:49
  and
• 6:49
  sort
• 6:49
  out
• 6:49
  the
• 6:49
  regulatory?
• 6:50
  So,
• 6:50
  unfortunately,
• 6:51
  Hakeem,
• 6:51
  my
• 6:51
  experience
• 6:52
  is
• 6:52
  a
• 6:52
  bit
• 6:52
  like
• 6:52
  we,
• 6:53
  I
• 6:53
  consider
• 6:53
  myself
• 6:53
  to
• 6:54
  be
• 6:54
  a
• 6:54
  bit
• 6:54
  of
• 6:54
  a
• 6:54
  firefighter,
• 6:54
  so
• 6:55
  the
• 6:55
  fire
• 6:55
  has
• 6:55
  already
• 6:55
  begun
• 6:56
  and
• 6:56
  they
• 6:56
  sort
• 6:56
  of
• 6:56
  bring
• 6:56
  me
• 6:56
  in
• 6:56
  at
• 6:56
  the
• 6:57
  end
• 6:57
  and
• 6:57
  say,
• 6:57
  kep,
• 6:57
  can
• 6:57
  you
• 6:57
  fix
• 6:58
  this
• 6:58
  for
• 6:58
  us?
• 6:58
  Now
• 6:59
  in
• 6:59
  an
• 6:59
  ideal
• 6:59
  situation,
• 7:00
  and
• 7:00
  I
• 7:00
  think
• 7:00
  it
• 7:00
  is
• 7:00
  changing
• 7:01
  through
• 7:01
  education
• 7:02
  and
• 7:02
  speculative
• 7:03
  for
• 7:03
  those
• 7:03
  people
• 7:03
  who
• 7:03
  sort
• 7:03
  of
• 7:03
  follow
• 7:04
  me,
• 7:04
  speak
• 7:04
  to
• 7:04
  me
• 7:04
  a
• 7:04
  bit
• 7:04
  earlier
• 7:05
  on.
• 7:05
  So
• 7:05
  before
• 7:05
  they've
• 7:06
  even
• 7:06
  got
• 7:06
  to
• 7:06
  that
• 7:06
  point,
• 7:07
  I
• 7:07
  sort
• 7:07
  of
• 7:07
  help
• 7:07
  them
• 7:07
  put
• 7:08
  processes
• 7:08
  in
• 7:08
  the
• 7:08
  business
• 7:09
  to
• 7:09
  prevent
• 7:09
  that
• 7:10
  sort
• 7:10
  of
• 7:10
  thing
• 7:10
  happening.
• 7:10
  But
• 7:11
  usually
• 7:11
  in
• 7:11
  cases
• 7:11
  where
• 7:12
  companies
• 7:12
  have
• 7:12
  gone
• 7:12
  to
• 7:12
  the
• 7:12
  latest
• 7:13
  stage
• 7:13
  and
• 7:13
  try
• 7:13
  to
• 7:14
  fix
• 7:14
  it,
• 7:14
  I
• 7:14
  think
• 7:14
  it
• 7:14
  is
• 7:15
  changing
• 7:15
  as
• 7:15
  well.
• 7:15
  From
• 7:16
  my
• 7:16
  point
• 7:16
  of
• 7:16
  view
• 7:16
  is
• 7:16
  having
• 7:17
  attended
• 7:17
  conferences
• 7:18
  over
• 7:18
  the
• 7:18
  past
• 7:19
  sort
• 7:19
  of
• 7:19
  five
• 7:19
  years,
• 7:19
  more
• 7:20
  so
• 7:20
  I've
• 7:20
  noticed
• 7:20
  recently
• 7:21
  is
• 7:21
  that
• 7:21
  investors
• 7:22
  are
• 7:22
  now
• 7:22
  starting
• 7:23
  to
• 7:23
  do
• 7:23
  due
• 7:23
  diligence,
• 7:24
  not
• 7:24
  just
• 7:24
  on
• 7:24
  the
• 7:24
  commercial
• 7:25
  aspect.
• 7:25
  But
• 7:25
  also
• 7:25
  the
• 7:25
  regulatory.
• 7:26
  And
• 7:26
  when
• 7:27
  they're
• 7:27
  looking
• 7:27
  at
• 7:27
  sort
• 7:27
  of
• 7:27
  series
• 7:28
  A
• 7:28
  or
• 7:28
  series
• 7:28
  B
• 7:29
  funding
• 7:29
  of
• 7:29
  a
• 7:29
  company,
• 7:30
  they're
• 7:30
  always
• 7:30
  looking
• 7:30
  to
• 7:30
  see
• 7:31
  is
• 7:31
  commercial,
• 7:31
  speaking
• 7:32
  to
• 7:32
  regulatory.
• 7:33
  There
• 7:33
  was
• 7:33
  a
• 7:33
  time
• 7:33
  sometimes
• 7:34
  where
• 7:34
  the
• 7:34
  regulatory
• 7:34
  person
• 7:35
  isn't
• 7:35
  in
• 7:35
  the
• 7:35
  room.
• 7:36
  Now
• 7:36
  it
• 7:36
  is
• 7:36
  changing
• 7:36
  with
• 7:37
  the
• 7:37
  regulatory
• 7:37
  persons
• 7:38
  there,
• 7:38
  the
• 7:38
  clinical
• 7:38
  person's
• 7:39
  also
• 7:39
  then
• 7:39
  potentially
• 7:40
  the
• 7:40
  commercial
• 7:40
  person.
• 7:41
  And
• 7:41
  that
• 7:41
  is
• 7:41
  changing
• 7:41
  the
• 7:42
  way
• 7:42
  in
• 7:42
  which
• 7:42
  companies
• 7:42
  are
• 7:43
  seeing.
• 7:43
  So
• 7:43
  it's
• 7:43
  changing
• 7:44
  slowly
• 7:44
  but
• 7:44
  surely.
• 7:45
  Okay.
• 7:45
  So
• 7:45
  just
• 7:45
  picking
• 7:46
  up
• 7:46
  on
• 7:46
  that
• 7:46
  a
• 7:46
  bit
• 7:46
  more,
• 7:46
  'cause
• 7:46
  obviously
• 7:47
  as
• 7:47
  you
• 7:47
  said,
• 7:47
  investors
• 7:48
  are
• 7:48
  seeing
• 7:48
  it,
• 7:49
  and
• 7:49
  obviously
• 7:49
  investment
• 7:50
  is
• 7:50
  the
• 7:50
  lifeblood
• 7:50
  of
• 7:50
  MedTech.
• 7:51
  And
• 7:51
  you're
• 7:52
  generally
• 7:52
  brought
• 7:52
  in,
• 7:53
  as
• 7:53
  you
• 7:53
  said,
• 7:53
  as
• 7:53
  a
• 7:53
  firefighter
• 7:54
  to
• 7:54
  look
• 7:54
  at
• 7:54
  the
• 7:54
  regulatory
• 7:55
  strategy.
• 7:55
  So
• 7:56
  how
• 7:56
  do
• 7:56
  you,
• 7:56
  or
• 7:56
  how
• 7:57
  do
• 7:57
  you,
• 7:57
  or
• 7:57
  do
• 7:58
  you.
• 7:58
  And
• 7:58
  are
• 7:58
  you
• 7:58
  in
• 7:58
  the
• 7:59
  position
• 7:59
  to
• 7:59
  like
• 7:59
  guide
• 8:00
  your
• 8:01
  clients
• 8:01
  around
• 8:02
  the,
• 8:02
  that
• 8:02
  commercial
• 8:03
  plan
• 8:03
  alongside
• 8:04
  the
• 8:04
  regulatory
• 8:04
  strategy
• 8:05
  at
• 8:05
  any
• 8:05
  point?
• 8:05
  Or
• 8:05
  how
• 8:06
  does
• 8:06
  that
• 8:06
  work?
• 8:06
  'cause
• 8:07
  obviously
• 8:07
  you
• 8:07
  see
• 8:07
  it
• 8:07
  very
• 8:07
  clearly,
• 8:08
  that
• 8:08
  actually
• 8:08
  the
• 8:09
  regulatory
• 8:09
  and
• 8:09
  the
• 8:10
  commercial
• 8:10
  hand
• 8:10
  in
• 8:10
  hand.
• 8:11
  So
• 8:11
  how
• 8:11
  do
• 8:11
  you
• 8:11
  have
• 8:11
  that
• 8:11
  conversation
• 8:12
  with
• 8:12
  founders
• 8:13
  and
• 8:13
  organizations
• 8:14
  to
• 8:14
  make
• 8:14
  sure
• 8:14
  that
• 8:14
  they
• 8:14
  actually
• 8:14
  do
• 8:15
  that?
• 8:15
  'cause
• 8:15
  that's
• 8:15
  what
• 8:15
  gonna
• 8:15
  lead
• 8:16
  to
• 8:16
  success
• 8:16
  ultimately.
• 8:17
  Sure.
• 8:17
  It
• 8:17
  just
• 8:18
  starts
• 8:18
  off
• 8:18
  with
• 8:18
  education.
• 8:19
  That's
• 8:19
  really
• 8:19
  what
• 8:19
  it
• 8:19
  is.
• 8:20
  There's
• 8:20
  no
• 8:20
  use.
• 8:20
  Me
• 8:20
  just
• 8:21
  going
• 8:21
  in
• 8:21
  and
• 8:21
  saying,
• 8:21
  look,
• 8:21
  it's
• 8:21
  a
• 8:22
  requirement.
• 8:22
  We
• 8:22
  have
• 8:23
  to
• 8:23
  do
• 8:23
  it.
• 8:23
  Goals,
• 8:23
  why?
• 8:24
  Why
• 8:24
  I
• 8:24
  show
• 8:24
  them
• 8:24
  examples?
• 8:25
  That's
• 8:25
  the
• 8:25
  best
• 8:25
  way
• 8:25
  to,
• 8:26
  is
• 8:26
  lead
• 8:26
  through
• 8:26
  examples
• 8:27
  saying,
• 8:27
  look,
• 8:27
  these
• 8:27
  are
• 8:27
  examples.
• 8:28
  If
• 8:28
  you
• 8:28
  can
• 8:28
  find
• 8:29
  any
• 8:29
  public
• 8:29
  sort
• 8:29
  of
• 8:29
  information
• 8:30
  out
• 8:30
  there
• 8:30
  saying,
• 8:30
  these
• 8:31
  are
• 8:31
  examples
• 8:31
  that
• 8:31
  companies
• 8:32
  that
• 8:32
  got
• 8:32
  it
• 8:32
  wrong
• 8:32
  and
• 8:32
  these
• 8:33
  were
• 8:33
  the
• 8:33
  consequences.
• 8:33
  They
• 8:33
  weren't
• 8:34
  allowed
• 8:34
  to
• 8:34
  have
• 8:34
  sales
• 8:35
  or
• 8:35
  they
• 8:35
  basically
• 8:36
  had
• 8:36
  a
• 8:36
  recall.
• 8:36
  So
• 8:37
  I
• 8:37
  always
• 8:37
  try
• 8:37
  to
• 8:37
  lead
• 8:38
  for
• 8:38
  examples
• 8:39
  and
• 8:39
  the
• 8:39
  way
• 8:39
  that
• 8:39
  I
• 8:40
  do
• 8:40
  it
• 8:40
  is
• 8:40
  often
• 8:40
  show,
• 8:40
  hey
• 8:41
  look,
• 8:41
  this
• 8:41
  was
• 8:41
  an
• 8:41
  example
• 8:42
  of
• 8:42
  a
• 8:42
  company
• 8:42
  that
• 8:42
  sort
• 8:42
  of
• 8:43
  did
• 8:43
  it
• 8:43
  properly
• 8:43
  and
• 8:43
  these
• 8:43
  were
• 8:43
  the
• 8:44
  benefits
• 8:44
  that
• 8:44
  they
• 8:44
  got
• 8:44
  out
• 8:45
  of
• 8:45
  it.
• 8:45
  So
• 8:45
  when
• 8:45
  you're
• 8:45
  speaking
• 8:46
  to
• 8:46
  the
• 8:46
  CEOs
• 8:47
  and
• 8:47
  founders,
• 8:47
  they
• 8:47
  don't
• 8:47
  understand
• 8:48
  regulatory
• 8:48
  speak,
• 8:49
  and
• 8:49
  I
• 8:49
  think
• 8:49
  that's
• 8:49
  a
• 8:50
  mistake
• 8:50
  some
• 8:50
  consultants
• 8:51
  make.
• 8:51
  They
• 8:51
  start
• 8:51
  saying,
• 8:51
  I
• 8:52
  saw
• 8:52
  1,
• 8:52
  3,
• 8:52
  4,
• 8:52
  8,
• 8:53
  5,
• 8:53
  and
• 8:53
  14
• 8:53
  9
• 8:53
  7
• 8:54
  1,
• 8:54
  which
• 8:55
  again,
• 8:55
  as
• 8:55
  regulatory
• 8:56
  people,
• 8:56
  we
• 8:56
  get
• 8:56
  it,
• 8:56
  but
• 8:56
  the
• 8:56
  person
• 8:57
  at
• 8:57
  the
• 8:57
  other
• 8:57
  end
• 8:57
  of
• 8:57
  the
• 8:57
  desk
• 8:58
  has
• 8:58
  no
• 8:58
  idea
• 8:58
  what
• 8:59
  this
• 8:59
  stuff
• 8:59
  means.
• 8:59
  But
• 8:59
  if
• 8:59
  you
• 9:00
  say
• 9:00
  something
• 9:00
  like,
• 9:00
  Hey,
• 9:01
  the
• 9:01
  reason
• 9:01
  we
• 9:01
  have
• 9:01
  a
• 9:01
  risk
• 9:02
  analysis
• 9:02
  is
• 9:02
  to
• 9:02
  prevent
• 9:03
  the
• 9:03
  product
• 9:03
  going
• 9:03
  wrong
• 9:03
  in
• 9:03
  the
• 9:03
  market
• 9:04
  because
• 9:04
  if
• 9:04
  it
• 9:04
  goes
• 9:04
  wrong,
• 9:05
  it
• 9:05
  might
• 9:05
  harm
• 9:05
  somebody,
• 9:06
  which
• 9:06
  is
• 9:06
  course
• 9:06
  gonna
• 9:06
  harm
• 9:07
  sales
• 9:07
  and
• 9:07
  reputation.
• 9:08
  That
• 9:08
  on
• 9:08
  the
• 9:08
  other
• 9:08
  hand
• 9:09
  is
• 9:09
  go,
• 9:09
  okay,
• 9:09
  now
• 9:09
  we
• 9:10
  understand
• 9:10
  why
• 9:10
  we
• 9:10
  have
• 9:10
  to
• 9:11
  do
• 9:11
  this
• 9:11
  risk
• 9:11
  analysis
• 9:12
  and
• 9:12
  this
• 9:12
  sort
• 9:12
  of
• 9:12
  stuff.
• 9:12
  So
• 9:13
  it's
• 9:13
  all
• 9:13
  about
• 9:13
  speaking
• 9:13
  the
• 9:14
  language
• 9:14
  of
• 9:14
  which
• 9:14
  they
• 9:14
  understand.
• 9:15
  So
• 9:15
  simplifying
• 9:16
  it,
• 9:16
  making
• 9:16
  it
• 9:17
  easy
• 9:17
  to
• 9:17
  understand,
• 9:17
  saying,
• 9:18
  look,
• 9:18
  these
• 9:18
  are
• 9:18
  the
• 9:18
  requirements.
• 9:19
  This
• 9:19
  is
• 9:19
  why
• 9:19
  we
• 9:19
  do
• 9:20
  it,
• 9:20
  and
• 9:20
  when
• 9:20
  things
• 9:20
  go
• 9:21
  wrong,
• 9:21
  these
• 9:21
  are
• 9:21
  the
• 9:21
  consequences.
• 9:22
  That's
• 9:22
  the
• 9:22
  language
• 9:23
  of
• 9:23
  which
• 9:23
  they're
• 9:23
  gonna
• 9:23
  understand.
• 9:24
  Yeah,
• 9:24
  that
• 9:24
  makes
• 9:24
  perfect
• 9:25
  sense.
• 9:25
  So,
• 9:25
  I
• 9:25
  mean
• 9:26
  you
• 9:26
  said
• 9:26
  you
• 9:26
  speak
• 9:26
  for
• 9:27
  example,
• 9:27
  so
• 9:27
  can
• 9:27
  you
• 9:27
  gimme
• 9:28
  an
• 9:28
  example
• 9:28
  of
• 9:28
  where
• 9:28
  it
• 9:28
  went
• 9:29
  badly
• 9:29
  wrong
• 9:29
  because
• 9:30
  there
• 9:30
  was
• 9:30
  a
• 9:30
  misalignment
• 9:31
  and
• 9:31
  then
• 9:31
  the
• 9:31
  converse
• 9:32
  of,
• 9:32
  well,
• 9:32
  and
• 9:33
  when
• 9:33
  it
• 9:33
  went,
• 9:33
  when
• 9:34
  they
• 9:34
  did
• 9:34
  it
• 9:34
  like
• 9:34
  this
• 9:35
  was
• 9:35
  the
• 9:35
  benefit.
• 9:35
  Just
• 9:35
  so
• 9:36
  the
• 9:36
  listeners
• 9:36
  and
• 9:36
  the
• 9:36
  viewers
• 9:37
  get
• 9:37
  a
• 9:37
  real
• 9:38
  clear
• 9:38
  insight,
• 9:39
  move
• 9:39
  away
• 9:39
  from
• 9:40
  the
• 9:40
  hypothetical
• 9:41
  and
• 9:41
  the
• 9:41
  theory.
• 9:41
  Yeah,
• 9:42
  so
• 9:42
  this
• 9:42
  was
• 9:42
  a
• 9:42
  case
• 9:43
  of
• 9:43
  where
• 9:43
  unfortunately
• 9:43
  the
• 9:43
  company
• 9:44
  did
• 9:44
  bring
• 9:44
  me
• 9:44
  in
• 9:45
  quite
• 9:45
  late.
• 9:45
  They
• 9:45
  brought
• 9:45
  it
• 9:46
  out
• 9:46
  to
• 9:46
  the
• 9:46
  point
• 9:46
  where
• 9:46
  they
• 9:46
  got
• 9:46
  their
• 9:47
  five
• 9:47
  10
• 9:47
  K
• 9:47
  approval
• 9:48
  and
• 9:48
  they
• 9:48
  were
• 9:48
  very
• 9:48
  happy
• 9:48
  about
• 9:48
  it.
• 9:49
  Look,
• 9:49
  currently
• 9:49
  we've
• 9:49
  got
• 9:50
  a
• 9:50
  five
• 9:50
  10
• 9:50
  K
• 9:50
  approval.
• 9:51
  but
• 9:51
  we
• 9:51
  need
• 9:51
  now
• 9:51
  someone
• 9:52
  to
• 9:52
  just
• 9:52
  sort
• 9:52
  of
• 9:52
  maintain
• 9:53
  that
• 9:53
  while
• 9:53
  we
• 9:53
  move
• 9:53
  into
• 9:53
  sort
• 9:54
  of
• 9:54
  the
• 9:54
  commercial
• 9:54
  aspect
• 9:55
  of
• 9:55
  things.
• 9:55
  The
• 9:55
  problem
• 9:56
  was,
• 9:56
  is
• 9:56
  that
• 9:56
  they
• 9:57
  were
• 9:57
  chasing
• 9:57
  speed.
• 9:58
  For
• 9:59
  those
• 9:59
  people
• 9:59
  who
• 9:59
  are
• 9:59
  not
• 10:00
  familiar
• 10:00
  with
• 10:00
  the
• 10:00
  FDA
• 10:01
  five
• 10:01
  10
• 10:01
  K
• 10:01
  process,
• 10:02
  you
• 10:02
  have
• 10:02
  to
• 10:03
  prove
• 10:03
  that
• 10:03
  your
• 10:04
  product
• 10:04
  is
• 10:04
  substantially
• 10:05
  equivalent
• 10:05
  to
• 10:06
  something
• 10:06
  else
• 10:06
  that's
• 10:06
  already
• 10:06
  on
• 10:07
  the
• 10:07
  market,
• 10:07
  which
• 10:07
  is
• 10:07
  referenced
• 10:08
  known
• 10:08
  as
• 10:08
  a
• 10:08
  predictive
• 10:09
  device.
• 10:09
  Now,
• 10:10
  the
• 10:10
  problem,
• 10:10
  of
• 10:10
  course,
• 10:11
  is
• 10:11
  in
• 10:11
  order
• 10:11
  for
• 10:11
  them
• 10:12
  to
• 10:12
  prove
• 10:12
  substantial
• 10:13
  equivalence,
• 10:13
  they
• 10:13
  had
• 10:14
  to
• 10:14
  remove
• 10:14
  some
• 10:14
  features
• 10:15
  of
• 10:15
  their
• 10:15
  product.
• 10:15
  As
• 10:15
  a
• 10:15
  result
• 10:16
  of
• 10:16
  doing
• 10:16
  that,
• 10:17
  they
• 10:17
  also
• 10:17
  removed
• 10:17
  some
• 10:17
  of
• 10:18
  their
• 10:18
  unique
• 10:18
  selling
• 10:18
  points.
• 10:19
  So
• 10:19
  even
• 10:19
  though
• 10:20
  they
• 10:20
  got
• 10:20
  a
• 10:20
  regulatory
• 10:21
  approval,
• 10:21
  they've
• 10:21
  now
• 10:22
  in
• 10:22
  the
• 10:22
  end
• 10:22
  just
• 10:22
  ended
• 10:23
  up
• 10:23
  creating
• 10:23
  a
• 10:23
  me
• 10:24
  too
• 10:24
  device
• 10:24
  and
• 10:25
  were
• 10:25
  unable
• 10:25
  to
• 10:25
  differentiate
• 10:26
  themselves
• 10:26
  from
• 10:26
  their
• 10:27
  competitors
• 10:27
  just
• 10:28
  in
• 10:28
  the
• 10:28
  idea
• 10:29
  of
• 10:29
  speed.
• 10:29
  Now,
• 10:29
  had
• 10:30
  they
• 10:30
  held
• 10:30
  off
• 10:30
  and
• 10:31
  spent
• 10:31
  another
• 10:31
  six
• 10:31
  to
• 10:32
  12
• 10:32
  months
• 10:32
  and
• 10:32
  went
• 10:32
  down
• 10:32
  a
• 10:33
  day
• 10:33
  Novo
• 10:33
  Pathway,
• 10:34
  which
• 10:34
  is
• 10:34
  for
• 10:34
  when
• 10:34
  you
• 10:34
  have
• 10:34
  a
• 10:34
  completely
• 10:35
  novel
• 10:35
  product,
• 10:36
  they
• 10:36
  would've
• 10:36
  had
• 10:36
  their
• 10:36
  unique
• 10:37
  selling
• 10:37
  point.
• 10:37
  So
• 10:38
  just
• 10:38
  by
• 10:38
  chasing
• 10:39
  speed.
• 10:39
  They
• 10:39
  ended
• 10:39
  up
• 10:39
  getting
• 10:40
  a
• 10:40
  regulatory
• 10:40
  approval
• 10:41
  of
• 10:41
  which
• 10:41
  wasn't
• 10:41
  really
• 10:42
  commercially
• 10:42
  viable
• 10:42
  for
• 10:42
  them
• 10:43
  in
• 10:43
  the
• 10:43
  end.
• 10:43
  Yeah,
• 10:43
  and
• 10:44
  I
• 10:44
  suppose
• 10:44
  the
• 10:44
  challenge
• 10:44
  with
• 10:45
  the
• 10:45
  speed
• 10:45
  element
• 10:46
  is
• 10:46
  although
• 10:47
  there's
• 10:47
  nothing
• 10:47
  more
• 10:47
  costly
• 10:47
  than
• 10:48
  a
• 10:48
  product
• 10:48
  that
• 10:48
  you
• 10:48
  never
• 10:48
  sell.
• 10:49
  But
• 10:49
  I've
• 10:49
  worked
• 10:49
  with
• 10:50
  people
• 10:50
  like
• 10:50
  that
• 10:50
  before
• 10:50
  and
• 10:51
  it's,
• 10:51
  I
• 10:51
  often,
• 10:52
  because
• 10:52
  they've
• 10:52
  got
• 10:52
  funding
• 10:53
  for
• 10:53
  a
• 10:53
  certain
• 10:54
  period
• 10:54
  of
• 10:54
  time
• 10:54
  and
• 10:54
  they're
• 10:55
  thinking,
• 10:55
  well,
• 10:55
  we
• 10:55
  actually
• 10:55
  can't,
• 10:56
  we
• 10:56
  literally
• 10:56
  can't
• 10:57
  hang
• 10:57
  on
• 10:57
  for
• 10:57
  another
• 10:58
  six
• 10:58
  to
• 10:58
  12
• 10:58
  months
• 10:59
  ago
• 10:59
  de
• 10:59
  novo.
• 11:00
  So
• 11:00
  in
• 11:00
  that
• 11:00
  sub
• 11:01
  situation,
• 11:02
  I
• 11:02
  suppose
• 11:02
  what.
• 11:03
  Had
• 11:03
  you
• 11:03
  gotten
• 11:03
  there
• 11:03
  earlier,
• 11:04
  you'd
• 11:04
  been
• 11:04
  there,
• 11:05
  would've
• 11:05
  advised
• 11:05
  them
• 11:05
  in
• 11:05
  the
• 11:05
  right
• 11:05
  way.
• 11:06
  I
• 11:06
  suppose
• 11:06
  it's
• 11:06
  because
• 11:06
  they
• 11:06
  came
• 11:07
  to
• 11:07
  you
• 11:07
  when
• 11:07
  they've
• 11:07
  actually
• 11:07
  already
• 11:08
  done
• 11:08
  the
• 11:08
  five
• 11:08
  10
• 11:08
  K.
• 11:09
  So
• 11:09
  is
• 11:09
  it,
• 11:09
  had
• 11:10
  you
• 11:10
  gotten
• 11:10
  there
• 11:10
  earlier,
• 11:11
  is
• 11:11
  there
• 11:11
  anything
• 11:11
  that
• 11:12
  you
• 11:12
  could
• 11:12
  have
• 11:12
  done
• 11:12
  which
• 11:12
  would've
• 11:13
  married
• 11:13
  up
• 11:13
  their,
• 11:14
  the
• 11:14
  amount
• 11:14
  of
• 11:14
  money
• 11:14
  they
• 11:15
  had
• 11:15
  with
• 11:15
  the
• 11:16
  speed
• 11:16
  element,
• 11:16
  which
• 11:16
  was
• 11:16
  the
• 11:17
  challenge
• 11:17
  that
• 11:17
  they
• 11:17
  were
• 11:17
  try
• 11:17
  to
• 11:18
  find?
• 11:18
  Yeah,
• 11:18
  so
• 11:18
  in
• 11:18
  the
• 11:19
  case
• 11:19
  here
• 11:19
  and
• 11:19
  understand
• 11:20
  they
• 11:20
  are
• 11:20
  investor
• 11:20
  deadlines,
• 11:21
  but
• 11:21
  if
• 11:21
  you
• 11:21
  can,
• 11:21
  again,
• 11:22
  investors
• 11:23
  may
• 11:23
  not
• 11:23
  understand
• 11:23
  this,
• 11:23
  they
• 11:24
  just
• 11:24
  see
• 11:24
  a
• 11:24
  regulatory
• 11:24
  approval.
• 11:25
  They,
• 11:25
  yeah,
• 11:26
  see
• 11:26
  a
• 11:26
  five
• 11:26
  10
• 11:26
  K.
• 11:26
  They
• 11:26
  say
• 11:27
  a
• 11:27
  day
• 11:27
  of
• 11:27
  and
• 11:27
  go,
• 11:27
  this
• 11:27
  one's
• 11:28
  quicker.
• 11:28
  Let's
• 11:28
  pick
• 11:28
  that
• 11:29
  one.
• 11:29
  Not
• 11:29
  realizing
• 11:30
  the
• 11:30
  differences
• 11:30
  of
• 11:30
  it.
• 11:31
  So
• 11:31
  the
• 11:31
  way
• 11:31
  that
• 11:31
  I
• 11:31
  would've
• 11:32
  done
• 11:32
  it
• 11:32
  is
• 11:32
  I
• 11:32
  would've
• 11:32
  explained
• 11:33
  to
• 11:33
  them
• 11:33
  in
• 11:33
  a
• 11:33
  language
• 11:34
  again,
• 11:34
  that
• 11:34
  they
• 11:34
  understand
• 11:35
  saying,
• 11:35
  look,
• 11:35
  this
• 11:35
  is
• 11:35
  our
• 11:35
  unique
• 11:36
  selling
• 11:36
  point,
• 11:36
  but
• 11:37
  if
• 11:37
  we
• 11:37
  go
• 11:37
  down
• 11:37
  this
• 11:37
  pathway,
• 11:38
  we
• 11:38
  can
• 11:38
  make
• 11:38
  these
• 11:39
  claims.
• 11:39
  There's
• 11:39
  no
• 11:39
  other
• 11:40
  product
• 11:40
  like
• 11:40
  this
• 11:40
  on
• 11:40
  the
• 11:40
  market.
• 11:41
  We
• 11:41
  can
• 11:41
  get
• 11:41
  this
• 11:41
  particular
• 11:42
  reimbursement
• 11:43
  code,
• 11:43
  and
• 11:43
  this
• 11:43
  is
• 11:43
  the
• 11:43
  data
• 11:44
  to
• 11:44
  show
• 11:44
  that,
• 11:44
  hospitals
• 11:45
  are
• 11:45
  interested
• 11:45
  in
• 11:46
  it.
• 11:46
  So
• 11:46
  they
• 11:46
  would
• 11:46
  just
• 11:46
  see
• 11:46
  as,
• 11:47
  oh,
• 11:47
  well
• 11:47
  if
• 11:47
  we
• 11:47
  hold
• 11:48
  on
• 11:48
  for
• 11:48
  six
• 11:48
  months
• 11:48
  longer,
• 11:49
  for
• 11:49
  example,
• 11:49
  we
• 11:50
  can
• 11:50
  make
• 11:50
  two,
• 11:50
  three
• 11:51
  full
• 11:51
  times
• 11:51
  X
• 11:51
  profit
• 11:52
  than
• 11:52
  if
• 11:52
  we
• 11:52
  just
• 11:52
  get
• 11:53
  the
• 11:53
  five
• 11:53
  10
• 11:53
  k.
• 11:53
  And
• 11:53
  it's
• 11:54
  just
• 11:54
  that
• 11:54
  explaining
• 11:55
  to
• 11:55
  a
• 11:55
  language
• 11:55
  which
• 11:55
  they
• 11:56
  understand.
• 11:56
  Now
• 11:56
  in
• 11:56
  some
• 11:57
  cases
• 11:57
  like
• 11:57
  this,
• 11:57
  where
• 11:58
  the
• 11:58
  companies,
• 11:58
  the
• 11:58
  investors
• 11:59
  go
• 11:59
  get
• 11:59
  to
• 11:59
  the
• 11:59
  market
• 11:59
  as
• 12:00
  fast
• 12:00
  as
• 12:00
  possible,
• 12:00
  but
• 12:01
  they
• 12:01
  may
• 12:01
  not
• 12:01
  understand
• 12:01
  the
• 12:01
  consequences
• 12:02
  of
• 12:02
  going
• 12:03
  down
• 12:03
  something
• 12:03
  like
• 12:03
  a
• 12:03
  five
• 12:03
  10
• 12:04
  K.
• 12:04
  But
• 12:04
  if
• 12:04
  you
• 12:04
  explain
• 12:05
  that
• 12:05
  to
• 12:05
  them,
• 12:05
  you
• 12:06
  can
• 12:06
  potentially
• 12:06
  work
• 12:07
  with
• 12:07
  'em
• 12:07
  and
• 12:07
  extend
• 12:07
  that.
• 12:07
  Now,
• 12:08
  if
• 12:08
  they
• 12:08
  still
• 12:08
  want
• 12:08
  the
• 12:09
  five
• 12:09
  10
• 12:09
  K,
• 12:09
  then
• 12:10
  that's
• 12:10
  fine,
• 12:10
  but
• 12:10
  you
• 12:10
  explicitly
• 12:11
  say
• 12:11
  that
• 12:12
  to
• 12:12
  them
• 12:12
  because
• 12:12
  the
• 12:12
  last
• 12:12
  thing
• 12:12
  an
• 12:13
  investor
• 12:13
  wants
• 12:13
  is,
• 12:14
  why
• 12:14
  don't
• 12:14
  you
• 12:14
  tell
• 12:14
  me
• 12:14
  about
• 12:14
  this
• 12:15
  de
• 12:15
  Novo
• 12:15
  process
• 12:15
  earlier?
• 12:16
  We
• 12:16
  didn't
• 12:16
  realize
• 12:16
  that
• 12:17
  five
• 12:17
  10
• 12:17
  K
• 12:17
  was
• 12:17
  gonna
• 12:18
  be
• 12:18
  like
• 12:18
  this,
• 12:18
  but
• 12:18
  had
• 12:19
  you
• 12:19
  spoken
• 12:19
  to
• 12:19
  them
• 12:19
  earlier.
• 12:20
  And
• 12:20
  then
• 12:20
  the
• 12:20
  company
• 12:20
  still
• 12:21
  went
• 12:21
  into
• 12:21
  five
• 12:21
  10
• 12:21
  k
• 12:22
  at
• 12:22
  least
• 12:22
  then
• 12:22
  the
• 12:22
  company
• 12:22
  say,
• 12:22
  Hey,
• 12:23
  look,
• 12:23
  we
• 12:23
  held
• 12:23
  our
• 12:24
  end
• 12:24
  of
• 12:24
  the
• 12:24
  bargain.
• 12:24
  We
• 12:24
  did
• 12:24
  explain
• 12:25
  it.
• 12:25
  And
• 12:25
  then
• 12:25
  you've
• 12:25
  sort
• 12:26
  of
• 12:26
  protected
• 12:26
  yourself
• 12:27
  in
• 12:27
  that
• 12:27
  sense.
• 12:27
  Yeah.
• 12:28
  So
• 12:28
  effectively
• 12:29
  it's,
• 12:29
  again,
• 12:29
  it's
• 12:29
  a
• 12:29
  case
• 12:29
  of
• 12:30
  transparency.
• 12:31
  Well,
• 12:31
  it's
• 12:31
  understanding
• 12:32
  what's
• 12:33
  available
• 12:33
  and
• 12:33
  then
• 12:33
  transparency
• 12:34
  with
• 12:34
  all
• 12:34
  the
• 12:34
  people
• 12:35
  involved
• 12:35
  so
• 12:35
  that
• 12:36
  you
• 12:36
  can
• 12:36
  still
• 12:36
  make
• 12:36
  the
• 12:36
  decision
• 12:37
  that
• 12:37
  actually
• 12:37
  will
• 12:37
  go
• 12:38
  five,
• 12:38
  10
• 12:38
  K
• 12:38
  as
• 12:39
  opposed
• 12:39
  to
• 12:39
  de
• 12:39
  novo.
• 12:39
  But
• 12:40
  you
• 12:40
  have
• 12:40
  to
• 12:40
  understand
• 12:41
  what
• 12:41
  that
• 12:41
  means
• 12:42
  in
• 12:42
  terms
• 12:42
  of
• 12:42
  your
• 12:43
  market
• 12:43
  penetration
• 12:44
  because
• 12:44
  you're
• 12:44
  fi
• 12:45
  you're
• 12:45
  then
• 12:45
  fighting
• 12:45
  it
• 12:46
  out
• 12:46
  with.
• 12:46
  May,
• 12:46
  maybe
• 12:47
  not
• 12:47
  Lowe's,
• 12:47
  but
• 12:48
  some
• 12:48
  other
• 12:48
  products
• 12:49
  which
• 12:49
  are
• 12:49
  obviously
• 12:49
  there
• 12:50
  already
• 12:50
  and
• 12:50
  in
• 12:51
  the
• 12:51
  market
• 12:51
  as
• 12:51
  opposed
• 12:52
  to
• 12:52
  saying,
• 12:52
  yeah,
• 12:53
  we
• 12:53
  may
• 12:53
  be
• 12:53
  similar
• 12:53
  to
• 12:54
  that
• 12:54
  in
• 12:54
  terms
• 12:54
  of
• 12:55
  class,
• 12:55
  but
• 12:55
  actually
• 12:56
  we've
• 12:56
  gone
• 12:56
  back
• 12:56
  down
• 12:56
  to
• 12:56
  Novo,
• 12:57
  which
• 12:57
  means
• 12:57
  we're
• 12:57
  actually
• 12:57
  completely
• 12:58
  novel
• 12:59
  in
• 12:59
  terms
• 12:59
  of
• 12:59
  these
• 13:00
  things,
• 13:00
  which
• 13:01
  then,
• 13:02
  obviously
• 13:02
  have
• 13:02
  a
• 13:02
  completely
• 13:03
  different
• 13:03
  commercial
• 13:03
  impacts.
• 13:03
  Okay.
• 13:04
  So,
• 13:04
  and
• 13:04
  then
• 13:04
  have
• 13:05
  you
• 13:05
  got
• 13:05
  an
• 13:05
  example
• 13:05
  of
• 13:05
  where
• 13:06
  it
• 13:06
  went
• 13:06
  well
• 13:07
  where
• 13:07
  basically
• 13:07
  regulator
• 13:08
  and
• 13:08
  commercial
• 13:08
  were
• 13:08
  working
• 13:09
  hand
• 13:09
  in
• 13:09
  hand,
• 13:09
  and
• 13:10
  what
• 13:10
  was
• 13:10
  the
• 13:10
  result
• 13:10
  there?
• 13:11
  Yeah,
• 13:11
  definitely.
• 13:11
  So
• 13:11
  I've
• 13:12
  been
• 13:12
  in
• 13:12
  companies
• 13:12
  who
• 13:13
  sort
• 13:13
  of
• 13:13
  bring
• 13:13
  me
• 13:13
  on
• 13:13
  very
• 13:14
  early
• 13:14
  on,
• 13:14
  and
• 13:14
  the
• 13:14
  way
• 13:15
  that
• 13:15
  I
• 13:15
  do
• 13:15
  it
• 13:15
  is
• 13:15
  I
• 13:15
  create
• 13:16
  a
• 13:16
  regulatory
• 13:16
  strategy
• 13:17
  with
• 13:17
  them.
• 13:17
  So
• 13:17
  obviously
• 13:17
  they're
• 13:18
  often
• 13:18
  chasing
• 13:18
  speed
• 13:19
  and
• 13:19
  I
• 13:19
  talk
• 13:19
  about
• 13:19
  their
• 13:20
  drawbacks
• 13:20
  and
• 13:21
  speech.
• 13:21
  Now,
• 13:21
  the
• 13:21
  mistake
• 13:22
  that
• 13:22
  a
• 13:22
  lot
• 13:22
  of
• 13:22
  companies
• 13:23
  are
• 13:23
  making,
• 13:23
  and
• 13:23
  this
• 13:23
  is
• 13:23
  an
• 13:23
  example
• 13:24
  that
• 13:24
  I
• 13:24
  can
• 13:24
  give,
• 13:24
  is
• 13:25
  I
• 13:25
  kept
• 13:25
  saying
• 13:25
  to
• 13:25
  this
• 13:25
  company,
• 13:26
  well,
• 13:26
  why
• 13:26
  do
• 13:26
  you
• 13:26
  want
• 13:27
  to
• 13:27
  go
• 13:27
  to
• 13:27
  the
• 13:27
  US
• 13:27
  first?
• 13:28
  And
• 13:28
  they
• 13:28
  simply
• 13:28
  said,
• 13:29
  it's
• 13:29
  because
• 13:29
  the
• 13:29
  regulatory
• 13:30
  looks
• 13:30
  easier.
• 13:30
  But
• 13:31
  reality
• 13:31
  of
• 13:31
  the
• 13:31
  situation
• 13:32
  is
• 13:32
  when
• 13:32
  I
• 13:32
  looked
• 13:32
  at
• 13:33
  their
• 13:33
  studies,
• 13:33
  a
• 13:33
  lot
• 13:33
  of
• 13:34
  the
• 13:34
  studies
• 13:34
  were
• 13:34
  done
• 13:34
  in
• 13:35
  Africa,
• 13:35
  Asia,
• 13:36
  and
• 13:36
  Europe.
• 13:36
  Which
• 13:36
  are
• 13:36
  not
• 13:37
  representative
• 13:37
  of
• 13:37
  a
• 13:37
  US
• 13:38
  based
• 13:38
  population.
• 13:39
  So
• 13:39
  they
• 13:39
  just
• 13:39
  assumed
• 13:40
  that
• 13:40
  just
• 13:40
  because
• 13:40
  we'd
• 13:40
  done
• 13:41
  these
• 13:41
  studies
• 13:41
  on
• 13:41
  some,
• 13:42
  so
• 13:42
  much
• 13:42
  of
• 13:42
  a
• 13:42
  diverse
• 13:42
  part
• 13:43
  of
• 13:43
  the
• 13:43
  world,
• 13:43
  it's
• 13:43
  still
• 13:43
  not
• 13:44
  representative
• 13:44
  of
• 13:44
  a
• 13:44
  US
• 13:45
  population.
• 13:46
  And
• 13:46
  in
• 13:46
  this
• 13:46
  case
• 13:46
  here,
• 13:47
  that
• 13:47
  study
• 13:47
  would
• 13:47
  not
• 13:47
  have
• 13:48
  been
• 13:48
  accepted
• 13:48
  in
• 13:48
  the
• 13:48
  us.
• 13:49
  So
• 13:49
  they
• 13:49
  were
• 13:49
  under
• 13:50
  the
• 13:50
  impression
• 13:50
  that
• 13:50
  the
• 13:50
  US
• 13:51
  is
• 13:51
  sort
• 13:51
  of
• 13:51
  quicker.
• 13:52
  But
• 13:52
  when
• 13:52
  I
• 13:52
  looked
• 13:52
  at
• 13:52
  their
• 13:53
  data,
• 13:53
  it
• 13:53
  was
• 13:53
  a
• 13:53
  case
• 13:54
  of
• 13:54
  saying,
• 13:54
  no,
• 13:54
  I
• 13:54
  recommend
• 13:55
  that
• 13:55
  you
• 13:55
  go
• 13:55
  EU
• 13:56
  first
• 13:56
  because
• 13:56
  you've
• 13:56
  got
• 13:56
  the
• 13:56
  clinical
• 13:57
  data
• 13:57
  to
• 13:57
  back
• 13:57
  it.
• 13:58
  So
• 13:58
  the
• 13:58
  mistake
• 13:58
  that
• 13:58
  they
• 13:58
  would've
• 13:59
  made
• 13:59
  is,
• 13:59
  let's
• 13:59
  go
• 13:59
  us
• 14:00
  and
• 14:00
  then.
• 14:00
  Having
• 14:00
  done
• 14:00
  a
• 14:01
  pre-submission
• 14:01
  with
• 14:01
  the
• 14:01
  us,
• 14:02
  they
• 14:02
  potentially
• 14:02
  would've
• 14:02
  come
• 14:02
  back
• 14:03
  to
• 14:03
  'em
• 14:03
  and
• 14:03
  say,
• 14:03
  you
• 14:03
  need
• 14:03
  to
• 14:03
  do
• 14:04
  clinical
• 14:04
  studies
• 14:05
  based
• 14:05
  in
• 14:05
  the
• 14:05
  us.
• 14:06
  So
• 14:06
  it
• 14:06
  was
• 14:06
  a
• 14:06
  case
• 14:07
  of
• 14:07
  that
• 14:07
  helped
• 14:07
  saved
• 14:08
  a
• 14:08
  lot
• 14:08
  of
• 14:08
  time
• 14:08
  because
• 14:09
  even
• 14:09
  the
• 14:09
  pres
• 14:09
  sub
• 14:09
  processing,
• 14:10
  and
• 14:10
  I've
• 14:10
  done
• 14:10
  dunno
• 14:10
  the
• 14:10
  exact
• 14:11
  time,
• 14:11
  I
• 14:11
  think
• 14:11
  it's
• 14:11
  60
• 14:11
  to
• 14:11
  90
• 14:12
  days.
• 14:12
  I
• 14:12
  don
• 14:12
  get
• 14:13
  done,
• 14:13
  know
• 14:13
  the
• 14:13
  exact
• 14:13
  number
• 14:13
  off
• 14:14
  the
• 14:14
  top
• 14:14
  of
• 14:14
  my
• 14:14
  head.
• 14:14
  But
• 14:14
  that
• 14:15
  would've
• 14:15
  been
• 14:15
  three
• 14:15
  months
• 14:15
  of
• 14:15
  them
• 14:16
  waiting
• 14:16
  feedback
• 14:16
  on
• 14:17
  the
• 14:17
  FDA
• 14:17
  where
• 14:17
  they
• 14:17
  could
• 14:17
  have
• 14:18
  just
• 14:18
  cracked
• 14:18
  on
• 14:18
  with
• 14:18
  an
• 14:18
  EU
• 14:19
  submission.
• 14:19
  Yeah.
• 14:19
  So
• 14:19
  I
• 14:20
  think
• 14:20
  the
• 14:20
  space
• 14:20
  here
• 14:20
  is
• 14:21
  all
• 14:21
  about
• 14:21
  time.
• 14:21
  Every
• 14:22
  time
• 14:22
  you
• 14:22
  are
• 14:22
  having
• 14:22
  pre-submission
• 14:23
  or.
• 14:24
  Discussions
• 14:24
  with
• 14:24
  anyone.
• 14:25
  Again,
• 14:25
  it's
• 14:25
  time
• 14:25
  that
• 14:25
  you
• 14:26
  are
• 14:26
  not
• 14:26
  on
• 14:26
  the
• 14:26
  market
• 14:26
  and
• 14:26
  you're
• 14:27
  potentially
• 14:27
  risking
• 14:27
  another
• 14:28
  competitor
• 14:28
  coming
• 14:28
  in.
• 14:29
  So
• 14:29
  that
• 14:29
  is
• 14:29
  a
• 14:29
  case
• 14:30
  of
• 14:30
  where
• 14:30
  you
• 14:30
  can
• 14:31
  mitigate
• 14:31
  in
• 14:31
  terms
• 14:32
  of
• 14:32
  regulatory
• 14:32
  full
• 14:33
  speed.
• 14:33
  Okay.
• 14:33
  Yeah,
• 14:33
  that
• 14:34
  makes
• 14:34
  perfect
• 14:34
  sense
• 14:34
  actually.
• 14:35
  So
• 14:35
  it's
• 14:35
  about
• 14:35
  getting
• 14:36
  people
• 14:36
  in
• 14:36
  it.
• 14:37
  The
• 14:37
  earlier
• 14:37
  you
• 14:37
  can
• 14:37
  get
• 14:37
  people
• 14:38
  in
• 14:38
  are
• 14:38
  the
• 14:38
  better.
• 14:39
  And
• 14:39
  I
• 14:39
  suppose
• 14:40
  the
• 14:40
  question
• 14:40
  I
• 14:40
  would
• 14:40
  ask
• 14:41
  is,
• 14:41
  especially
• 14:41
  with
• 14:41
  founders
• 14:42
  and
• 14:42
  startups,
• 14:43
  what
• 14:43
  I've
• 14:43
  noticed,
• 14:43
  and
• 14:44
  it'd
• 14:44
  be
• 14:44
  interesting
• 14:44
  to
• 14:45
  see
• 14:45
  your
• 14:45
  views
• 14:45
  that
• 14:46
  most
• 14:47
  startups
• 14:47
  seem
• 14:47
  to
• 14:47
  try
• 14:48
  and
• 14:48
  do
• 14:48
  all
• 14:48
  the
• 14:48
  bits,
• 14:49
  the
• 14:49
  regulatory
• 14:50
  bits
• 14:50
  themselves
• 14:50
  were
• 14:50
  at
• 14:50
  the
• 14:51
  beginning
• 14:51
  'cause
• 14:51
  it's
• 14:51
  cheaper.
• 14:51
  So
• 14:52
  the
• 14:52
  regulatory
• 14:52
  they
• 14:53
  bring
• 14:53
  when
• 14:53
  they've
• 14:53
  actually
• 14:54
  got
• 14:54
  down.
• 14:55
  Some
• 14:55
  way
• 14:56
  across
• 14:56
  the
• 14:56
  pathway.
• 14:57
  They've
• 14:57
  done
• 14:57
  a
• 14:57
  like
• 14:57
  make
• 14:57
  a,
• 14:58
  they've
• 14:58
  done
• 14:58
  a
• 14:58
  bit
• 14:58
  of
• 14:58
  patent
• 14:59
  submission,
• 14:59
  they've
• 14:59
  done
• 15:00
  a
• 15:00
  bit
• 15:00
  of
• 15:00
  regulatory
• 15:00
  here,
• 15:01
  they've
• 15:01
  investigated
• 15:02
  it,
• 15:02
  outsourced
• 15:03
  it
• 15:03
  a
• 15:03
  little
• 15:03
  bit.
• 15:03
  So
• 15:04
  if
• 15:04
  that's
• 15:04
  something
• 15:05
  that
• 15:05
  you
• 15:05
  see,
• 15:05
  what
• 15:06
  would
• 15:06
  be
• 15:06
  your
• 15:06
  recommendation
• 15:07
  in
• 15:07
  terms
• 15:07
  of
• 15:08
  at
• 15:08
  what
• 15:08
  point
• 15:09
  should
• 15:09
  a
• 15:09
  starter
• 15:10
  start
• 15:11
  up
• 15:11
  or
• 15:11
  a
• 15:11
  founder
• 15:12
  be
• 15:12
  thinking
• 15:12
  actually.
• 15:13
  When
• 15:13
  I
• 15:13
  get
• 15:13
  to
• 15:13
  this
• 15:14
  point,
• 15:14
  I
• 15:14
  need
• 15:14
  to
• 15:14
  get
• 15:14
  regulatory
• 15:15
  and
• 15:15
  I
• 15:15
  need
• 15:15
  to
• 15:15
  be
• 15:16
  discussing
• 15:16
  with
• 15:16
  them
• 15:16
  what
• 15:17
  the
• 15:17
  commercial
• 15:17
  strategy
• 15:18
  that
• 15:18
  as
• 15:18
  well.
• 15:18
  So
• 15:19
  at
• 15:19
  the
• 15:19
  very
• 15:19
  least,
• 15:19
  right
• 15:20
  at
• 15:20
  the
• 15:20
  start
• 15:20
  of
• 15:20
  where
• 15:20
  they
• 15:20
  come
• 15:21
  up
• 15:21
  with
• 15:21
  the
• 15:21
  idea,
• 15:21
  the
• 15:21
  concept
• 15:22
  of
• 15:22
  the
• 15:22
  idea,
• 15:23
  they
• 15:23
  should
• 15:23
  have
• 15:24
  be
• 15:24
  speaking
• 15:24
  to
• 15:24
  a
• 15:24
  regulatory
• 15:25
  expert
• 15:26
  to
• 15:26
  see
• 15:26
  whether
• 15:27
  it's
• 15:27
  possible
• 15:27
  for
• 15:27
  them
• 15:28
  to
• 15:28
  even
• 15:28
  release
• 15:28
  a
• 15:28
  product
• 15:29
  like
• 15:29
  that
• 15:29
  with
• 15:29
  the
• 15:29
  kind
• 15:29
  of
• 15:29
  claims
• 15:30
  that
• 15:30
  they're
• 15:30
  making.
• 15:30
  That
• 15:31
  person
• 15:31
  can
• 15:31
  then
• 15:31
  check,
• 15:32
  okay,
• 15:32
  is
• 15:32
  the
• 15:32
  existing
• 15:33
  clinical
• 15:33
  data,
• 15:33
  do
• 15:33
  we
• 15:33
  need
• 15:34
  to
• 15:34
  do
• 15:34
  our
• 15:34
  own
• 15:34
  clinical
• 15:34
  studies?
• 15:35
  Are
• 15:35
  some
• 15:35
  of
• 15:35
  these
• 15:35
  claims
• 15:36
  that
• 15:36
  need
• 15:36
  to
• 15:36
  be
• 15:36
  removed?
• 15:37
  What
• 15:37
  is
• 15:37
  allowed
• 15:37
  and
• 15:38
  what
• 15:38
  isn't
• 15:38
  allowed?
• 15:38
  An
• 15:38
  example
• 15:39
  I
• 15:39
  can
• 15:39
  give
• 15:39
  is.
• 15:40
  There's
• 15:40
  a
• 15:40
  lot
• 15:40
  of
• 15:40
  companies
• 15:40
  out
• 15:41
  there
• 15:41
  saying,
• 15:41
  we
• 15:41
  want
• 15:41
  to
• 15:41
  bring
• 15:41
  an
• 15:41
  LLM
• 15:42
  onto
• 15:42
  the
• 15:42
  market
• 15:43
  as
• 15:43
  a
• 15:43
  medical
• 15:43
  device.
• 15:44
  Sorry,
• 15:44
  not
• 15:44
  realizing,
• 15:45
  An
• 15:45
  LLMA
• 15:46
  large
• 15:46
  language
• 15:46
  model.
• 15:46
  Oh,
• 15:47
  okay.
• 15:47
  Yeah,
• 15:47
  sorry.
• 15:48
  Yeah.
• 15:48
  At
• 15:48
  GPT
• 15:48
  and
• 15:49
  I
• 15:49
  have
• 15:49
  to
• 15:49
  explain
• 15:49
  to
• 15:49
  them
• 15:50
  at
• 15:50
  the
• 15:50
  point
• 15:50
  of
• 15:50
  submission,
• 15:50
  the
• 15:50
  model
• 15:51
  is
• 15:51
  locked
• 15:51
  so
• 15:51
  it
• 15:52
  wouldn't
• 15:52
  work
• 15:52
  like
• 15:52
  a
• 15:52
  traditional
• 15:53
  LLM.
• 15:53
  And
• 15:53
  then
• 15:54
  had
• 15:54
  they
• 15:54
  spoke
• 15:54
  to
• 15:54
  someone
• 15:55
  like
• 15:55
  me,
• 15:55
  they
• 15:55
  would
• 15:55
  not
• 15:55
  have
• 15:55
  sort
• 15:56
  of
• 15:56
  wasted
• 15:56
  time
• 15:56
  coming
• 15:57
  up
• 15:57
  with
• 15:57
  this
• 15:57
  idea
• 15:57
  or
• 15:57
  concept
• 15:58
  where
• 15:58
  I
• 15:58
  said,
• 15:59
  would've
• 15:59
  said
• 15:59
  to
• 15:59
  them,
• 15:59
  yes,
• 15:59
  you
• 16:00
  can
• 16:00
  have
• 16:00
  an
• 16:00
  LLM,
• 16:00
  but
• 16:01
  we
• 16:01
  need
• 16:01
  to
• 16:01
  lock
• 16:01
  the
• 16:01
  model
• 16:01
  at
• 16:02
  this
• 16:02
  point.
• 16:02
  And
• 16:02
  they
• 16:02
  got
• 16:02
  our
• 16:02
  great,
• 16:03
  that's
• 16:03
  our
• 16:03
  limitation.
• 16:04
  So
• 16:04
  the
• 16:04
  earlier
• 16:04
  they
• 16:05
  speak
• 16:05
  to
• 16:05
  someone,
• 16:05
  the
• 16:06
  quicker
• 16:06
  they
• 16:06
  can
• 16:06
  get
• 16:06
  that
• 16:07
  typical
• 16:07
  sort
• 16:07
  of
• 16:07
  advice,
• 16:08
  whether
• 16:08
  to
• 16:08
  see
• 16:08
  whether
• 16:08
  the
• 16:08
  idea
• 16:09
  is
• 16:09
  perceivable
• 16:09
  or
• 16:09
  not.
• 16:10
  A
• 16:10
  second
• 16:10
  point,
• 16:10
  of
• 16:11
  course,
• 16:11
  is
• 16:11
  my
• 16:11
  recommendation
• 16:12
  is,
• 16:12
  alongside
• 16:13
  regulatory.
• 16:14
  Once
• 16:14
  they've
• 16:14
  got
• 16:14
  that
• 16:14
  regulatory
• 16:15
  piece
• 16:15
  saying,
• 16:15
  okay,
• 16:16
  this
• 16:16
  is
• 16:16
  what
• 16:16
  the
• 16:16
  product's
• 16:16
  gonna
• 16:17
  look
• 16:17
  like,
• 16:17
  they
• 16:17
  then
• 16:18
  need
• 16:18
  to
• 16:18
  speak
• 16:18
  to
• 16:18
  someone
• 16:19
  who
• 16:19
  understands
• 16:20
  effectively
• 16:20
  health
• 16:21
  economics.
• 16:21
  Just
• 16:22
  because
• 16:22
  physicians
• 16:23
  love
• 16:23
  your
• 16:23
  product
• 16:23
  doesn't
• 16:24
  automatically
• 16:24
  mean
• 16:24
  that
• 16:24
  your
• 16:25
  product's
• 16:25
  gonna
• 16:25
  sell
• 16:25
  because
• 16:26
  the
• 16:26
  physician
• 16:26
  might
• 16:27
  be
• 16:27
  the
• 16:27
  user,
• 16:27
  but
• 16:27
  they're
• 16:27
  not
• 16:28
  the
• 16:28
  buyer.
• 16:28
  If
• 16:28
  you
• 16:28
  say
• 16:29
  something
• 16:29
  to
• 16:29
  me
• 16:29
  like
• 16:29
  a
• 16:29
  hospital
• 16:30
  that
• 16:30
  said
• 16:30
  that
• 16:30
  they
• 16:30
  wanna
• 16:31
  buy
• 16:31
  a
• 16:31
  hundred
• 16:31
  units
• 16:31
  of
• 16:32
  your
• 16:32
  product,
• 16:32
  I
• 16:32
  would
• 16:32
  say,
• 16:32
  okay,
• 16:33
  that's
• 16:33
  great.
• 16:33
  To
• 16:33
  me,
• 16:34
  that's
• 16:34
  saying
• 16:34
  the
• 16:34
  product's
• 16:34
  commercially
• 16:35
  viable,
• 16:35
  not
• 16:36
  just
• 16:36
  a
• 16:36
  surgeon
• 16:36
  at
• 16:37
  such
• 16:37
  and
• 16:37
  such
• 16:37
  university
• 16:38
  said
• 16:38
  that
• 16:38
  we
• 16:38
  will
• 16:38
  love
• 16:38
  to
• 16:39
  use
• 16:39
  this
• 16:39
  product
• 16:39
  and
• 16:39
  this
• 16:39
  would
• 16:40
  change
• 16:40
  the
• 16:40
  way
• 16:40
  in
• 16:40
  which
• 16:41
  we
• 16:41
  work.
• 16:41
  That's
• 16:41
  great,
• 16:42
  but
• 16:42
  that
• 16:42
  doesn't
• 16:42
  equal
• 16:42
  a
• 16:42
  sale.
• 16:43
  Yeah,
• 16:43
  And
• 16:43
  that's
• 16:44
  one
• 16:44
  of
• 16:44
  the
• 16:45
  biggest
• 16:45
  challenges,
• 16:45
  I
• 16:46
  think
• 16:46
  because.
• 16:46
  Firstly,
• 16:47
  a
• 16:47
  lot
• 16:47
  of
• 16:47
  people,
• 16:48
  and
• 16:48
  certainly
• 16:49
  a
• 16:49
  lot
• 16:49
  of
• 16:49
  people
• 16:49
  who
• 16:49
  listen
• 16:49
  to
• 16:50
  this
• 16:50
  podcast
• 16:51
  are
• 16:51
  medical
• 16:52
  inventors,
• 16:52
  so
• 16:52
  they
• 16:52
  come
• 16:53
  from
• 16:53
  a
• 16:53
  clinical
• 16:53
  background.
• 16:54
  So
• 16:55
  in
• 16:55
  their
• 16:55
  mind,
• 16:55
  well,
• 16:56
  I'm
• 16:56
  a
• 16:56
  clinician
• 16:57
  and
• 16:57
  I
• 16:57
  work
• 16:57
  in
• 16:57
  this
• 16:57
  area,
• 16:58
  and
• 16:58
  I
• 16:58
  think
• 16:58
  it's
• 16:58
  a
• 16:58
  great
• 16:58
  idea.
• 16:59
  I've
• 16:59
  then
• 16:59
  spoken
• 17:00
  to
• 17:00
  about
• 17:00
  two
• 17:00
  or
• 17:00
  three
• 17:00
  other
• 17:00
  people
• 17:01
  who
• 17:01
  are
• 17:01
  friends
• 17:01
  of
• 17:01
  mine,
• 17:02
  or
• 17:02
  people
• 17:02
  that
• 17:03
  I
• 17:03
  know,
• 17:03
  and
• 17:03
  they've
• 17:03
  said,
• 17:03
  it's
• 17:03
  a
• 17:03
  great
• 17:04
  idea,
• 17:04
  and
• 17:04
  they
• 17:04
  automatically
• 17:05
  assume
• 17:06
  that
• 17:06
  that
• 17:06
  means
• 17:06
  that
• 17:06
  everyone's
• 17:06
  gonna
• 17:07
  buy
• 17:07
  it.
• 17:07
  And
• 17:07
  I
• 17:07
  said,
• 17:08
  so
• 17:08
  I
• 17:08
  think
• 17:08
  what
• 17:08
  you
• 17:08
  just
• 17:08
  said
• 17:08
  there,
• 17:09
  the
• 17:09
  really
• 17:09
  important
• 17:10
  point,
• 17:10
  in
• 17:10
  terms
• 17:11
  of
• 17:11
  you
• 17:11
  need
• 17:11
  a.
• 17:11
  A
• 17:12
  system
• 17:12
  or
• 17:12
  a
• 17:12
  hospital
• 17:13
  saying,
• 17:13
  yes,
• 17:14
  this
• 17:14
  is
• 17:14
  something
• 17:14
  that
• 17:14
  we'd
• 17:14
  be
• 17:14
  really
• 17:15
  interested
• 17:15
  in.
• 17:16
  And
• 17:16
  whether
• 17:16
  that's
• 17:16
  through
• 17:16
  trials
• 17:17
  or
• 17:17
  even
• 17:17
  just
• 17:17
  seeing
• 17:18
  the
• 17:18
  data
• 17:18
  rather
• 17:18
  than
• 17:19
  just
• 17:19
  a
• 17:19
  few
• 17:20
  individuals,
• 17:21
  sporadic
• 17:21
  individuals
• 17:22
  around
• 17:22
  the
• 17:22
  place
• 17:22
  saying,
• 17:22
  oh
• 17:23
  yeah,
• 17:23
  we
• 17:23
  think
• 17:23
  it's
• 17:23
  great,
• 17:24
  because
• 17:24
  that
• 17:25
  does
• 17:25
  not
• 17:25
  automatically
• 17:26
  lead
• 17:26
  to
• 17:26
  pe
• 17:27
  to,
• 17:27
  to
• 17:27
  hospitals
• 17:27
  purchasing
• 17:28
  it.
• 17:28
  And
• 17:28
  unfortunately,
• 17:29
  the
• 17:29
  healthcare
• 17:30
  environment
• 17:30
  now
• 17:30
  and
• 17:31
  actually.
• 17:31
  America,
• 17:32
  the
• 17:32
  clinicians
• 17:33
  still
• 17:33
  probably
• 17:33
  have
• 17:33
  a
• 17:33
  bit
• 17:33
  more
• 17:34
  influence
• 17:35
  over
• 17:35
  what
• 17:35
  happens
• 17:36
  than
• 17:37
  in
• 17:37
  the
• 17:37
  UK
• 17:38
  and
• 17:38
  actually
• 17:38
  in
• 17:38
  Europe,
• 17:39
  but.
• 17:39
  It's
• 17:39
  not
• 17:40
  a
• 17:40
  decision
• 17:40
  of
• 17:40
  a
• 17:40
  clinician.
• 17:41
  The
• 17:41
  clinician
• 17:41
  can
• 17:41
  like
• 17:42
  it,
• 17:42
  and
• 17:42
  it
• 17:42
  doesn't
• 17:42
  go
• 17:42
  anywhere
• 17:43
  because
• 17:43
  procurement
• 17:44
  or
• 17:45
  whoever
• 17:45
  else
• 17:45
  gets
• 17:45
  involved
• 17:46
  and
• 17:46
  says,
• 17:46
  well,
• 17:46
  actually,
• 17:47
  you
• 17:47
  may
• 17:47
  like
• 17:48
  it,
• 17:48
  but
• 17:48
  I
• 17:48
  don't.
• 17:48
  And
• 17:48
  the
• 17:49
  price
• 17:49
  isn't
• 17:49
  quite
• 17:49
  right,
• 17:50
  et
• 17:50
  cetera.
• 17:50
  So
• 17:50
  I
• 17:50
  think
• 17:51
  that's
• 17:51
  a,
• 17:51
  an
• 17:51
  important
• 17:52
  point
• 17:52
  for
• 17:52
  everybody,
• 17:53
  to
• 17:53
  take
• 17:53
  on
• 17:53
  board.
• 17:53
  So
• 17:54
  just
• 17:54
  on,
• 17:54
  on
• 17:55
  in
• 17:55
  terms
• 17:55
  of
• 17:55
  that,
• 17:56
  if
• 17:56
  you're
• 17:56
  giving
• 17:57
  advice
• 17:57
  to
• 17:57
  people
• 17:57
  listening
• 17:58
  in
• 17:58
  terms
• 17:59
  of.
• 17:59
  Getting
• 18:00
  that
• 18:00
  understanding
• 18:01
  of
• 18:01
  that
• 18:01
  commercial
• 18:02
  viability,
• 18:02
  around
• 18:03
  not
• 18:03
  just
• 18:03
  being
• 18:04
  a,
• 18:04
  an
• 18:04
  individual
• 18:04
  doctor,
• 18:05
  but
• 18:05
  really
• 18:05
  around
• 18:06
  hospital
• 18:07
  buying
• 18:07
  behavior,
• 18:08
  for
• 18:08
  example,
• 18:08
  how,
• 18:09
  what
• 18:09
  advice
• 18:10
  would
• 18:10
  you
• 18:10
  give
• 18:10
  them
• 18:10
  in
• 18:11
  terms
• 18:11
  of
• 18:11
  understanding
• 18:13
  how
• 18:13
  what
• 18:13
  happens
• 18:14
  in
• 18:14
  the
• 18:15
  hospital
• 18:15
  or
• 18:16
  at
• 18:16
  that
• 18:16
  level
• 18:17
  should
• 18:17
  impact
• 18:18
  your
• 18:18
  regulatory
• 18:18
  submissions
• 18:19
  as
• 18:19
  well
• 18:19
  as
• 18:19
  the
• 18:19
  commercial?
• 18:20
  Yeah,
• 18:20
  so
• 18:21
  the
• 18:21
  example
• 18:21
  I
• 18:21
  can
• 18:21
  give
• 18:22
  here
• 18:22
  is
• 18:22
  for
• 18:22
  the
• 18:22
  us.
• 18:23
  So
• 18:23
  the
• 18:23
  US
• 18:23
  is
• 18:24
  the
• 18:24
  reimbursement
• 18:24
  system.
• 18:25
  So
• 18:25
  depending
• 18:26
  on
• 18:26
  what
• 18:26
  your
• 18:26
  product
• 18:27
  is,
• 18:27
  you
• 18:27
  get
• 18:27
  what's
• 18:27
  known
• 18:27
  as
• 18:28
  a
• 18:28
  reimbursement
• 18:29
  code,
• 18:29
  and
• 18:29
  that
• 18:29
  can
• 18:29
  determine
• 18:30
  sort
• 18:30
  of
• 18:30
  how
• 18:30
  much,
• 18:30
  you'll
• 18:30
  get
• 18:31
  paid
• 18:31
  for
• 18:31
  that
• 18:31
  particular
• 18:31
  product.
• 18:32
  Now,
• 18:32
  there
• 18:33
  are
• 18:33
  certain
• 18:33
  circumstances
• 18:34
  of
• 18:34
  which
• 18:34
  you
• 18:34
  might
• 18:35
  have
• 18:35
  one
• 18:35
  product
• 18:35
  that
• 18:36
  potentially
• 18:36
  sits
• 18:36
  in
• 18:37
  between
• 18:37
  two
• 18:37
  reimbursement
• 18:38
  codes.
• 18:39
  One
• 18:39
  reimbursement
• 18:39
  code
• 18:40
  could
• 18:40
  be
• 18:40
  many
• 18:40
  times
• 18:41
  more
• 18:41
  profitable
• 18:41
  for
• 18:41
  your
• 18:41
  company
• 18:42
  than
• 18:42
  the
• 18:42
  other
• 18:42
  one.
• 18:43
  So
• 18:43
  had
• 18:43
  you
• 18:43
  looked
• 18:44
  at
• 18:44
  the
• 18:44
  sort
• 18:44
  of
• 18:44
  regulatory
• 18:45
  piece
• 18:45
  early,
• 18:45
  you
• 18:45
  might
• 18:45
  be
• 18:46
  thinking,
• 18:46
  ah,
• 18:46
  let's
• 18:46
  maybe
• 18:47
  change
• 18:47
  this
• 18:47
  claim
• 18:47
  and
• 18:47
  let's
• 18:48
  say
• 18:48
  that
• 18:48
  this
• 18:48
  product
• 18:48
  is
• 18:49
  this
• 18:49
  instead
• 18:49
  of
• 18:49
  that,
• 18:50
  that
• 18:50
  can
• 18:50
  potentially
• 18:50
  push
• 18:51
  you
• 18:51
  into
• 18:51
  a
• 18:51
  different
• 18:51
  reimbursement
• 18:52
  code,
• 18:52
  which
• 18:52
  can
• 18:53
  be
• 18:53
  more
• 18:53
  profitable
• 18:53
  for
• 18:53
  your
• 18:54
  company.
• 18:54
  So
• 18:54
  I
• 18:54
  think
• 18:54
  that's
• 18:55
  a
• 18:55
  very
• 18:55
  important
• 18:55
  decision
• 18:56
  that
• 18:56
  companies
• 18:56
  need
• 18:56
  to
• 18:56
  make
• 18:57
  very
• 18:57
  early
• 18:57
  on,
• 18:57
  is
• 18:58
  this
• 18:58
  is
• 18:58
  the
• 18:58
  regulatory
• 18:59
  piece,
• 18:59
  this
• 18:59
  is
• 18:59
  what
• 19:00
  the
• 19:00
  product's
• 19:00
  gonna
• 19:00
  be.
• 19:00
  What
• 19:01
  potential
• 19:01
  reimbursement
• 19:02
  code
• 19:02
  or
• 19:02
  codes
• 19:03
  would
• 19:03
  it
• 19:03
  fall
• 19:04
  under?
• 19:04
  And
• 19:04
  at
• 19:04
  that
• 19:04
  point,
• 19:05
  is
• 19:05
  it
• 19:05
  economically
• 19:05
  viable
• 19:06
  to
• 19:06
  sell
• 19:06
  it
• 19:06
  like
• 19:06
  that?
• 19:07
  That's
• 19:07
  an
• 19:07
  important
• 19:07
  piece
• 19:07
  that
• 19:07
  a
• 19:08
  lot
• 19:08
  of
• 19:08
  companies
• 19:08
  miss
• 19:08
  out
• 19:09
  on.
• 19:09
  And
• 19:09
  of
• 19:09
  course,
• 19:09
  the
• 19:09
  reimbursement
• 19:10
  phase
• 19:10
  can
• 19:10
  take
• 19:11
  just
• 19:11
  as
• 19:11
  long
• 19:11
  as
• 19:11
  regulatory,
• 19:12
  if
• 19:12
  not
• 19:12
  more.
• 19:13
  It's
• 19:13
  not
• 19:13
  uncommon
• 19:13
  to
• 19:13
  see
• 19:13
  that
• 19:14
  it
• 19:14
  can
• 19:14
  take
• 19:14
  a
• 19:14
  few
• 19:14
  years,
• 19:15
  it
• 19:15
  can
• 19:15
  take
• 19:15
  shorter.
• 19:16
  The
• 19:16
  last
• 19:16
  thing
• 19:16
  you
• 19:16
  want
• 19:16
  is
• 19:17
  to
• 19:17
  get
• 19:17
  your
• 19:17
  regulatory
• 19:17
  approval
• 19:18
  and
• 19:18
  then
• 19:18
  you're
• 19:18
  sitting
• 19:18
  for
• 19:19
  another
• 19:19
  three
• 19:19
  years
• 19:19
  before
• 19:20
  you
• 19:20
  can
• 19:20
  get
• 19:20
  your
• 19:20
  reimbursement
• 19:21
  code.
• 19:21
  So
• 19:21
  if
• 19:21
  your
• 19:21
  strategy
• 19:22
  is
• 19:22
  working
• 19:22
  together
• 19:23
  and
• 19:23
  ensuring
• 19:23
  that
• 19:24
  your
• 19:24
  regulatory
• 19:24
  is
• 19:24
  aligned
• 19:25
  with
• 19:25
  your
• 19:25
  sort
• 19:25
  of
• 19:25
  health
• 19:26
  economics.
• 19:26
  You
• 19:26
  can
• 19:26
  make
• 19:26
  sure
• 19:27
  that
• 19:27
  the
• 19:27
  timing
• 19:27
  of
• 19:27
  the
• 19:27
  regulatory
• 19:28
  and
• 19:29
  also
• 19:29
  the
• 19:29
  reimbursement
• 19:30
  card
• 19:30
  are
• 19:30
  aligned,
• 19:30
  so
• 19:31
  at
• 19:31
  least
• 19:31
  then
• 19:31
  you
• 19:31
  can
• 19:31
  start
• 19:31
  making
• 19:32
  sales
• 19:32
  soon
• 19:32
  as
• 19:32
  you
• 19:32
  hit
• 19:32
  the
• 19:33
  market.
• 19:33
  Yeah,
• 19:33
  no,
• 19:33
  I,
• 19:33
  that's
• 19:34
  a
• 19:34
  really
• 19:34
  important
• 19:34
  point,
• 19:35
  isn't
• 19:35
  it?
• 19:35
  Because
• 19:35
  it's
• 19:35
  not,
• 19:36
  and
• 19:36
  this
• 19:36
  is
• 19:36
  what
• 19:36
  we
• 19:36
  talk
• 19:36
  about
• 19:37
  all
• 19:37
  the
• 19:37
  time.
• 19:37
  This
• 19:37
  is
• 19:37
  the
• 19:38
  purpose
• 19:38
  of
• 19:38
  this
• 19:38
  episode.
• 19:39
  It's
• 19:39
  not
• 19:39
  just
• 19:40
  about,
• 19:40
  you've
• 19:40
  got
• 19:40
  regulatory
• 19:41
  and
• 19:41
  then
• 19:42
  you
• 19:42
  start
• 19:42
  thinking
• 19:42
  about
• 19:43
  what
• 19:43
  you
• 19:43
  do
• 19:43
  next.
• 19:43
  cause
• 19:43
  if,
• 19:44
  as
• 19:44
  you
• 19:44
  said,
• 19:44
  if
• 19:44
  you
• 19:44
  can't,
• 19:45
  if
• 19:45
  you
• 19:45
  can't
• 19:45
  get
• 19:45
  it
• 19:45
  reimbursed,
• 19:46
  then
• 19:46
  it's
• 19:46
  gonna
• 19:46
  be
• 19:47
  harder
• 19:47
  to
• 19:47
  sell
• 19:47
  it.
• 19:47
  You
• 19:47
  can
• 19:47
  still
• 19:48
  sell
• 19:48
  it,
• 19:48
  but
• 19:48
  it's,
• 19:48
  it
• 19:48
  is
• 19:48
  gonna
• 19:48
  be
• 19:49
  much
• 19:49
  harder
• 19:49
  to
• 19:49
  sell
• 19:50
  it.
• 19:50
  And
• 19:50
  if
• 19:50
  you
• 19:50
  don't
• 19:50
  understand
• 19:51
  and
• 19:51
  not,
• 19:51
  it's
• 19:51
  not
• 19:51
  even
• 19:52
  just
• 19:52
  having
• 19:52
  the
• 19:52
  reimbursement
• 19:53
  code,
• 19:53
  it's
• 19:53
  understanding
• 19:54
  how
• 19:54
  they
• 19:54
  work.
• 19:54
  Because
• 19:55
  you
• 19:55
  will
• 19:55
  be
• 19:55
  asked
• 19:56
  as
• 19:56
  soon
• 19:56
  as
• 19:56
  you
• 19:56
  get
• 19:56
  into
• 19:56
  the
• 19:56
  market.
• 19:57
  The
• 19:57
  first,
• 19:57
  the,
• 19:58
  in
• 19:58
  the
• 19:58
  US
• 19:59
  the
• 19:59
  first
• 19:59
  thing
• 19:59
  they
• 19:59
  ask
• 19:59
  you
• 19:59
  is,
• 20:00
  oh,
• 20:00
  have
• 20:00
  you
• 20:00
  got
• 20:00
  regulatory
• 20:01
  approval?
• 20:01
  A
• 20:01
  have
• 20:01
  you
• 20:01
  got
• 20:02
  an
• 20:02
  FDA
• 20:02
  approval?
• 20:02
  That's
• 20:03
  the
• 20:03
  first
• 20:03
  thing.
• 20:03
  And
• 20:03
  then
• 20:03
  that
• 20:04
  thing
• 20:04
  is,
• 20:04
  oh,
• 20:04
  what's
• 20:04
  the
• 20:04
  reimbursement
• 20:05
  code?
• 20:05
  And
• 20:05
  if
• 20:05
  you
• 20:05
  don't,
• 20:06
  if
• 20:06
  you
• 20:06
  don't
• 20:06
  have
• 20:06
  answers,
• 20:07
  clear
• 20:07
  answers
• 20:07
  to
• 20:07
  those,
• 20:08
  then
• 20:08
  the
• 20:08
  marketplace
• 20:09
  starts
• 20:09
  thinking,
• 20:09
  Hmm,
• 20:10
  are
• 20:10
  they
• 20:10
  really
• 20:11
  serious?
• 20:11
  'cause
• 20:12
  they
• 20:12
  don't
• 20:12
  really
• 20:12
  understand
• 20:13
  the
• 20:13
  US
• 20:13
  'cause
• 20:13
  they
• 20:13
  don't
• 20:14
  know
• 20:14
  the
• 20:14
  answers
• 20:15
  to
• 20:15
  those
• 20:15
  questions.
• 20:15
  So
• 20:16
  I
• 20:16
  think
• 20:16
  that's,
• 20:16
  that
• 20:16
  is
• 20:17
  important
• 20:17
  and
• 20:17
  it's
• 20:17
  really
• 20:18
  critical,
• 20:19
  as
• 20:19
  you're
• 20:19
  starting
• 20:20
  on
• 20:20
  any
• 20:20
  journey
• 20:21
  to
• 20:21
  really
• 20:21
  understand
• 20:22
  the
• 20:22
  whole
• 20:22
  of
• 20:22
  the
• 20:22
  picture.
• 20:23
  So,
• 20:23
  as
• 20:23
  Karen
• 20:23
  Beep
• 20:24
  said,
• 20:24
  I
• 20:24
  think
• 20:25
  it
• 20:25
  is
• 20:25
  critical
• 20:26
  for
• 20:27
  people
• 20:27
  to
• 20:27
  get
• 20:27
  at
• 20:28
  least,
• 20:28
  I
• 20:28
  forgot
• 20:29
  you
• 20:29
  described
• 20:29
  there,
• 20:29
  the,
• 20:30
  that
• 20:30
  initial
• 20:31
  review
• 20:32
  of
• 20:32
  the
• 20:32
  viability
• 20:33
  of
• 20:33
  the
• 20:33
  product.
• 20:33
  So
• 20:33
  that
• 20:34
  you
• 20:34
  know,
• 20:34
  what
• 20:35
  path
• 20:35
  you
• 20:35
  want
• 20:35
  to
• 20:35
  go
• 20:35
  down.
• 20:35
  And
• 20:35
  I
• 20:35
  think
• 20:36
  that's
• 20:36
  a
• 20:36
  really,
• 20:37
  good
• 20:37
  example
• 20:38
  of,
• 20:38
  you
• 20:38
  might
• 20:38
  sit
• 20:38
  in
• 20:39
  between
• 20:39
  two
• 20:39
  reimbursement
• 20:40
  codes
• 20:40
  where
• 20:41
  you
• 20:41
  want
• 20:41
  to
• 20:41
  go
• 20:41
  down
• 20:41
  the
• 20:41
  one
• 20:41
  that's
• 20:42
  gonna
• 20:42
  give
• 20:42
  you
• 20:42
  the
• 20:42
  most
• 20:42
  money
• 20:42
  rather
• 20:43
  than
• 20:43
  the
• 20:43
  other
• 20:43
  one.
• 20:44
  Or
• 20:44
  at
• 20:44
  least
• 20:45
  you
• 20:45
  want
• 20:45
  to
• 20:45
  know
• 20:45
  what
• 20:46
  those
• 20:46
  two
• 20:46
  opportunities
• 20:47
  are
• 20:47
  and
• 20:47
  make
• 20:47
  a
• 20:47
  decision
• 20:48
  based
• 20:48
  on
• 20:48
  fact,
• 20:49
  rather
• 20:49
  than
• 20:49
  just
• 20:50
  guessing,
• 20:51
  getting
• 20:51
  to
• 20:51
  the
• 20:51
  market
• 20:52
  and
• 20:52
  then
• 20:52
  finding,
• 20:52
  oh.
• 20:52
  We
• 20:53
  could
• 20:53
  have
• 20:53
  done
• 20:53
  this,
• 20:53
  but
• 20:53
  we
• 20:54
  didn't
• 20:54
  know
• 20:54
  about
• 20:54
  that.
• 20:55
  So
• 20:55
  in
• 20:55
  terms
• 20:55
  of
• 20:55
  frameworks,
• 20:57
  there
• 20:57
  any
• 20:57
  specific
• 20:58
  regulatory
• 20:59
  frameworks
• 20:59
  that
• 21:00
  you
• 21:00
  use
• 21:01
  that
• 21:01
  are
• 21:01
  particularly
• 21:02
  well
• 21:02
  suited
• 21:02
  for
• 21:03
  commercial
• 21:03
  success?
• 21:04
  Or
• 21:04
  is
• 21:04
  that
• 21:05
  dependent
• 21:05
  on
• 21:06
  the
• 21:06
  particular
• 21:06
  products
• 21:06
  or
• 21:07
  service
• 21:07
  that
• 21:07
  you're
• 21:07
  working
• 21:08
  with?
• 21:08
  I
• 21:08
  don't
• 21:08
  think
• 21:08
  there's
• 21:09
  a
• 21:09
  set
• 21:09
  framework
• 21:09
  as
• 21:09
  such.
• 21:10
  So
• 21:10
  it
• 21:10
  really
• 21:10
  depends
• 21:11
  on
• 21:11
  the
• 21:11
  type
• 21:11
  of
• 21:11
  product
• 21:11
  you
• 21:12
  have
• 21:12
  and
• 21:12
  where
• 21:12
  you're
• 21:13
  working.
• 21:13
  Is
• 21:13
  it
• 21:13
  a
• 21:13
  physical
• 21:14
  product?
• 21:14
  Is
• 21:14
  it
• 21:14
  a
• 21:14
  software
• 21:15
  As
• 21:15
  a
• 21:15
  medical
• 21:15
  device?
• 21:15
  But
• 21:16
  my
• 21:16
  recommendation
• 21:16
  is
• 21:17
  for
• 21:17
  any
• 21:17
  of
• 21:17
  the
• 21:17
  listeners
• 21:17
  today
• 21:18
  is.
• 21:18
  The
• 21:18
  regulations
• 21:19
  are
• 21:19
  free,
• 21:19
  completely
• 21:20
  online.
• 21:20
  The
• 21:20
  FDA
• 21:21
  has
• 21:21
  guidance
• 21:21
  documents.
• 21:22
  The
• 21:22
  medical
• 21:22
  device
• 21:22
  coordination
• 21:23
  group
• 21:23
  has
• 21:24
  documents.
• 21:24
  There
• 21:25
  are
• 21:25
  tons
• 21:25
  and
• 21:25
  tons
• 21:26
  of
• 21:26
  guidance
• 21:26
  documents
• 21:27
  out
• 21:27
  there
• 21:27
  helping
• 21:28
  you
• 21:28
  understand
• 21:28
  the
• 21:28
  regulatory
• 21:29
  process.
• 21:29
  My
• 21:30
  view
• 21:30
  here
• 21:30
  is
• 21:30
  by
• 21:30
  all
• 21:31
  means,
• 21:31
  hire
• 21:31
  professional
• 21:32
  people
• 21:32
  in
• 21:32
  commercial
• 21:33
  and
• 21:33
  regulatory,
• 21:34
  but
• 21:34
  you
• 21:34
  should
• 21:34
  have
• 21:34
  a
• 21:34
  basic
• 21:35
  understanding
• 21:35
  of
• 21:35
  it.
• 21:35
  And
• 21:36
  the
• 21:36
  example
• 21:36
  I
• 21:36
  give
• 21:36
  for
• 21:36
  anyone
• 21:37
  who
• 21:37
  runs
• 21:37
  a
• 21:37
  business
• 21:38
  is
• 21:38
  you
• 21:38
  may
• 21:38
  not
• 21:38
  understand
• 21:39
  accounting
• 21:39
  in
• 21:40
  and
• 21:40
  out,
• 21:40
  but
• 21:40
  you
• 21:40
  should
• 21:40
  also
• 21:40
  have
• 21:41
  a
• 21:41
  basic
• 21:41
  understanding
• 21:42
  of
• 21:42
  things
• 21:42
  like
• 21:42
  VAT
• 21:43
  and
• 21:43
  how
• 21:43
  often
• 21:43
  do
• 21:43
  your
• 21:43
  returns.
• 21:44
  So
• 21:44
  my
• 21:44
  view
• 21:45
  is
• 21:45
  if
• 21:45
  you
• 21:45
  really
• 21:45
  wanna
• 21:46
  succeed
• 21:46
  is
• 21:46
  at
• 21:46
  least
• 21:47
  go
• 21:47
  out
• 21:47
  and
• 21:47
  get
• 21:47
  yourself
• 21:47
  the
• 21:47
  base
• 21:48
  level
• 21:48
  knowledge
• 21:48
  for
• 21:49
  the
• 21:49
  very
• 21:49
  point
• 21:49
  is
• 21:49
  that
• 21:49
  you
• 21:50
  then
• 21:50
  begin
• 21:50
  to
• 21:50
  understand
• 21:51
  what
• 21:51
  these
• 21:51
  experts
• 21:51
  are
• 21:51
  actually
• 21:52
  talking
• 21:52
  about.
• 21:52
  Yeah,
• 21:53
  I
• 21:53
  think
• 21:53
  that's,
• 21:53
  that
• 21:54
  is
• 21:54
  a
• 21:54
  key
• 21:55
  element
• 21:55
  because
• 21:56
  I
• 21:56
  think
• 21:56
  if
• 21:56
  you
• 21:56
  said
• 21:56
  right
• 21:56
  at
• 21:56
  the
• 21:56
  beginning,
• 21:57
  re
• 21:58
  and
• 21:58
  this
• 21:58
  is
• 21:58
  not
• 21:58
  just
• 21:58
  regulator
• 21:59
  consultants,
• 21:59
  it's
• 22:00
  any
• 22:00
  consultant
• 22:01
  has
• 22:01
  a
• 22:01
  specific
• 22:02
  language.
• 22:02
  Commercial
• 22:02
  people
• 22:03
  have,
• 22:03
  a
• 22:03
  commercial
• 22:04
  language,
• 22:04
  reor
• 22:05
  have
• 22:05
  a
• 22:05
  regulatory
• 22:05
  language
• 22:06
  and
• 22:06
  they
• 22:06
  all
• 22:06
  come
• 22:06
  in
• 22:07
  and
• 22:07
  assume.
• 22:08
  The
• 22:08
  person
• 22:08
  they're
• 22:08
  speaking
• 22:09
  to
• 22:09
  understand
• 22:09
  exactly
• 22:10
  what
• 22:10
  they're
• 22:10
  talking
• 22:10
  about.
• 22:11
  And
• 22:11
  they
• 22:11
  don't
• 22:11
  necessarily
• 22:12
  bring,
• 22:12
  they
• 22:12
  don't
• 22:12
  necessarily
• 22:13
  bring
• 22:13
  it
• 22:13
  down
• 22:13
  to
• 22:13
  a,
• 22:13
  like
• 22:14
  a
• 22:14
  layman's
• 22:14
  level.
• 22:15
  So
• 22:15
  if
• 22:15
  you
• 22:15
  don't
• 22:16
  understand
• 22:17
  those
• 22:17
  things,
• 22:17
  then
• 22:17
  when
• 22:18
  people
• 22:18
  are
• 22:18
  talking
• 22:18
  to
• 22:18
  you
• 22:18
  about,
• 22:19
  EBITDA
• 22:19
  and
• 22:20
  gross
• 22:20
  margin,
• 22:21
  et
• 22:21
  cetera,
• 22:21
  or
• 22:21
  they're
• 22:21
  talking
• 22:22
  about
• 22:22
  the
• 22:22
  ISOs
• 22:23
  and
• 22:23
  you're
• 22:23
  sitting
• 22:23
  there
• 22:23
  nodding
• 22:24
  along
• 22:24
  thinking,
• 22:24
  oh,
• 22:24
  yeah.
• 22:25
  You
• 22:25
  might
• 22:25
  not
• 22:25
  have
• 22:25
  a
• 22:25
  clue
• 22:26
  what
• 22:26
  they're
• 22:26
  talking
• 22:26
  about
• 22:27
  and
• 22:27
  therefore
• 22:27
  you're
• 22:27
  making
• 22:27
  decisions
• 22:28
  based
• 22:28
  on
• 22:28
  information
• 22:29
  that
• 22:29
  you
• 22:30
  don't
• 22:30
  really
• 22:30
  understand.
• 22:31
  So
• 22:31
  I
• 22:31
  think
• 22:31
  you
• 22:31
  are
• 22:31
  right.
• 22:32
  It
• 22:32
  is
• 22:32
  critical,
• 22:33
  I
• 22:33
  think,
• 22:33
  to
• 22:33
  get
• 22:33
  an
• 22:34
  understanding
• 22:34
  at
• 22:34
  least
• 22:34
  of
• 22:34
  the
• 22:35
  basics
• 22:35
  of
• 22:35
  what
• 22:36
  commercial
• 22:36
  launch
• 22:36
  is
• 22:36
  looking
• 22:37
  like
• 22:37
  and
• 22:37
  what
• 22:38
  are
• 22:38
  the
• 22:38
  things
• 22:38
  that
• 22:38
  you
• 22:38
  need
• 22:38
  to
• 22:39
  consider.
• 22:39
  You
• 22:39
  might.
• 22:40
  Be
• 22:40
  able
• 22:40
  to
• 22:40
  make
• 22:40
  decisions,
• 22:40
  but
• 22:41
  at
• 22:41
  least
• 22:41
  you've
• 22:41
  got
• 22:41
  an
• 22:41
  understanding.
• 22:42
  So
• 22:42
  when
• 22:42
  you
• 22:42
  speak
• 22:42
  to
• 22:42
  a
• 22:42
  commercial
• 22:43
  person,
• 22:43
  you
• 22:44
  understand
• 22:44
  that.
• 22:44
  And
• 22:44
  the
• 22:44
  same
• 22:44
  thing
• 22:44
  from
• 22:45
  a
• 22:45
  regulatory,
• 22:45
  position.
• 22:46
  You
• 22:46
  need
• 22:46
  to
• 22:46
  be
• 22:46
  able
• 22:46
  to
• 22:47
  have
• 22:47
  at
• 22:47
  least
• 22:47
  intelligent
• 22:48
  conversations
• 22:49
  about
• 22:49
  what
• 22:50
  paths
• 22:50
  that
• 22:50
  are
• 22:50
  going
• 22:50
  down,
• 22:51
  what
• 22:51
  the
• 22:51
  key
• 22:52
  things
• 22:52
  that
• 22:52
  you
• 22:52
  need
• 22:52
  from
• 22:53
  an
• 22:53
  FDA,
• 22:53
  situation,
• 22:54
  or
• 22:54
  a
• 22:54
  ce
• 22:55
  mark,
• 22:55
  et
• 22:55
  cetera,
• 22:56
  so
• 22:56
  that
• 22:56
  you
• 22:56
  actually,
• 22:57
  you
• 22:57
  at
• 22:57
  least
• 22:58
  understand
• 22:58
  a
• 22:58
  bit
• 22:59
  of
• 22:59
  what
• 23:00
  the
• 23:00
  conversation
• 23:01
  that
• 23:01
  you're
• 23:01
  having.
• 23:01
  So
• 23:01
  I
• 23:01
  think
• 23:02
  that's
• 23:02
  an
• 23:02
  important
• 23:02
  thing.
• 23:03
  So
• 23:03
  in
• 23:03
  terms
• 23:03
  of.
• 23:03
  Your
• 23:04
  experience,
• 23:04
  over
• 23:05
  many,
• 23:05
  many
• 23:06
  different
• 23:06
  products
• 23:06
  over
• 23:07
  many,
• 23:07
  many
• 23:07
  years,
• 23:08
  what
• 23:08
  would
• 23:08
  you
• 23:08
  say
• 23:09
  would
• 23:09
  be
• 23:09
  the
• 23:09
  most
• 23:09
  valuable
• 23:10
  lesson
• 23:11
  you've
• 23:11
  learned
• 23:11
  about
• 23:12
  integrating
• 23:12
  that
• 23:12
  regulatory
• 23:13
  strategy
• 23:13
  with
• 23:13
  market
• 23:14
  objectives
• 23:15
  and
• 23:15
  commercial,
• 23:16
  implementation?
• 23:17
  So
• 23:17
  the
• 23:17
  first
• 23:18
  thing
• 23:18
  is
• 23:19
  quality
• 23:19
  management
• 23:19
  systems.
• 23:20
  A
• 23:20
  quality
• 23:20
  management
• 23:21
  system
• 23:21
  is
• 23:21
  built,
• 23:22
  not
• 23:22
  bought.
• 23:23
  Yes,
• 23:23
  you
• 23:23
  can
• 23:23
  go
• 23:23
  online
• 23:24
  and
• 23:24
  buy
• 23:24
  EQMS
• 23:25
  systems
• 23:25
  and
• 23:26
  there's
• 23:26
  very
• 23:26
  good
• 23:26
  ones
• 23:26
  out
• 23:27
  there.
• 23:27
  But
• 23:27
  it's
• 23:27
  something
• 23:27
  that
• 23:28
  you
• 23:28
  need
• 23:28
  to
• 23:28
  build
• 23:28
  internally
• 23:29
  and
• 23:29
  tailor
• 23:29
  for
• 23:29
  yourself,
• 23:30
  for
• 23:30
  your
• 23:30
  company.
• 23:30
  The
• 23:30
  same
• 23:31
  goes
• 23:31
  with
• 23:31
  companies
• 23:32
  who
• 23:32
  think
• 23:32
  they
• 23:32
  can
• 23:32
  just
• 23:32
  go
• 23:33
  and
• 23:33
  buy
• 23:33
  regulatory
• 23:33
  templates.
• 23:34
  Some
• 23:34
  of
• 23:34
  them
• 23:34
  may
• 23:34
  be
• 23:35
  great,
• 23:35
  but
• 23:35
  then
• 23:35
  you
• 23:35
  also
• 23:36
  need
• 23:36
  someone
• 23:36
  who
• 23:36
  understands
• 23:37
  'em
• 23:37
  and
• 23:37
  can
• 23:37
  tailor
• 23:37
  them
• 23:38
  to
• 23:38
  your
• 23:38
  actual
• 23:38
  company.
• 23:39
  So
• 23:39
  things
• 23:39
  are
• 23:40
  built,
• 23:40
  not
• 23:40
  bought
• 23:41
  is
• 23:41
  the
• 23:41
  main
• 23:41
  one
• 23:41
  there
• 23:42
  to
• 23:42
  understand.
• 23:42
  Another
• 23:43
  point
• 23:43
  is
• 23:43
  the
• 23:43
  device
• 23:44
  that
• 23:44
  you
• 23:44
  get
• 23:44
  your
• 23:44
  regulatory
• 23:45
  approval
• 23:45
  for
• 23:46
  should
• 23:46
  be
• 23:46
  the
• 23:46
  type
• 23:46
  of
• 23:46
  device
• 23:47
  that
• 23:47
  you
• 23:47
  can
• 23:47
  sell.
• 23:48
  So
• 23:48
  what
• 23:48
  do
• 23:48
  I
• 23:48
  mean
• 23:48
  by
• 23:49
  that?
• 23:49
  Sometimes
• 23:49
  companies
• 23:50
  are
• 23:50
  removing
• 23:51
  claims,
• 23:51
  as
• 23:51
  I
• 23:51
  was
• 23:51
  talking
• 23:52
  about
• 23:52
  earlier,
• 23:52
  to
• 23:52
  get
• 23:53
  that
• 23:53
  regulatory
• 23:53
  approval
• 23:54
  a
• 23:54
  bit
• 23:54
  quicker.
• 23:54
  But
• 23:54
  then
• 23:55
  as
• 23:55
  a
• 23:55
  consequence
• 23:55
  of
• 23:55
  that,
• 23:56
  they
• 23:56
  end
• 23:56
  up
• 23:56
  with
• 23:56
  a
• 23:56
  device
• 23:56
  which
• 23:57
  nobody
• 23:57
  really
• 23:57
  wants
• 23:57
  to
• 23:58
  buy.
• 23:58
  So
• 23:58
  sometimes
• 23:59
  it's
• 23:59
  worth
• 23:59
  going
• 23:59
  the
• 23:59
  extra
• 24:00
  pathway
• 24:00
  or
• 24:01
  taking
• 24:01
  the
• 24:01
  longer
• 24:01
  route
• 24:02
  simply
• 24:02
  because
• 24:02
  you
• 24:02
  get
• 24:03
  a
• 24:03
  better
• 24:03
  product
• 24:03
  at
• 24:03
  the
• 24:03
  end
• 24:04
  of
• 24:04
  something
• 24:04
  that
• 24:04
  you
• 24:04
  can
• 24:04
  actually
• 24:05
  sell.
• 24:05
  So
• 24:05
  don't
• 24:06
  try
• 24:06
  to,
• 24:07
  basically
• 24:07
  try
• 24:08
  to
• 24:08
  do
• 24:08
  everything
• 24:08
  as
• 24:08
  fast
• 24:09
  as
• 24:09
  possible,
• 24:09
  because
• 24:09
  then
• 24:09
  in
• 24:10
  reality
• 24:10
  you
• 24:10
  might
• 24:10
  get
• 24:10
  to
• 24:11
  market
• 24:11
  quicker,
• 24:11
  but
• 24:11
  then
• 24:12
  you
• 24:12
  may
• 24:12
  not
• 24:12
  have
• 24:12
  anything
• 24:12
  to
• 24:12
  sell
• 24:13
  at
• 24:13
  all,
• 24:13
  very
• 24:13
  wise.
• 24:13
  And
• 24:14
  just
• 24:14
  on
• 24:14
  that.
• 24:15
  Last
• 24:15
  point.
• 24:15
  'cause
• 24:16
  I
• 24:16
  see
• 24:16
  of
• 24:16
  often
• 24:17
  the
• 24:17
  convert.
• 24:17
  'cause
• 24:17
  what
• 24:17
  you're
• 24:18
  talking
• 24:18
  about
• 24:18
  is
• 24:18
  actually,
• 24:19
  they
• 24:19
  want
• 24:19
  to
• 24:19
  get
• 24:19
  to
• 24:19
  the
• 24:19
  market
• 24:20
  quickly
• 24:20
  so
• 24:20
  they
• 24:20
  take
• 24:21
  stuff
• 24:21
  out
• 24:21
  because.
• 24:21
  In
• 24:22
  your
• 24:22
  example,
• 24:23
  the
• 24:23
  FDA,
• 24:23
  you
• 24:23
  wanna
• 24:23
  do
• 24:23
  a
• 24:24
  five
• 24:24
  10
• 24:24
  care
• 24:24
  as
• 24:24
  opposed
• 24:25
  to
• 24:25
  a
• 24:25
  de
• 24:25
  novo.
• 24:25
  So
• 24:26
  you
• 24:26
  just
• 24:26
  say,
• 24:26
  okay,
• 24:26
  well
• 24:26
  we're
• 24:26
  gonna
• 24:27
  do
• 24:27
  this,
• 24:27
  and
• 24:27
  then
• 24:27
  it's
• 24:27
  not,
• 24:28
  no
• 24:28
  one
• 24:28
  wants
• 24:28
  it.
• 24:28
  What
• 24:29
  about
• 24:29
  the
• 24:29
  other
• 24:29
  side
• 24:30
  whereby
• 24:30
  you
• 24:31
  go
• 24:31
  to
• 24:31
  the
• 24:31
  OR
• 24:31
  or
• 24:32
  you
• 24:32
  started
• 24:32
  testing
• 24:33
  it
• 24:33
  in
• 24:33
  the
• 24:33
  market
• 24:34
  and
• 24:34
  then
• 24:35
  someone
• 24:35
  is,
• 24:35
  oh,
• 24:35
  well
• 24:35
  can
• 24:35
  you
• 24:35
  make
• 24:36
  it
• 24:36
  blue?
• 24:36
  Oh,
• 24:36
  can
• 24:36
  you
• 24:37
  chain
• 24:37
  this?
• 24:37
  Can
• 24:38
  you
• 24:38
  add
• 24:38
  this
• 24:38
  on?
• 24:38
  What's
• 24:39
  your
• 24:39
  advice
• 24:39
  to
• 24:39
  those
• 24:40
  sorts
• 24:40
  of
• 24:40
  situations?
• 24:41
  'cause
• 24:41
  obviously.
• 24:41
  If
• 24:42
  you
• 24:42
  are
• 24:42
  going
• 24:42
  down
• 24:42
  one
• 24:42
  regulatory
• 24:43
  path,
• 24:43
  every
• 24:44
  time
• 24:44
  you're
• 24:44
  adding
• 24:44
  something
• 24:44
  on
• 24:45
  or
• 24:45
  making
• 24:46
  slightly
• 24:46
  different,
• 24:46
  that's
• 24:47
  not
• 24:47
  the
• 24:47
  same
• 24:47
  product
• 24:47
  that
• 24:47
  you
• 24:48
  are
• 24:48
  actually,
• 24:48
  going
• 24:48
  down
• 24:49
  the
• 24:49
  regulatory
• 24:49
  pathway
• 24:49
  for.
• 24:50
  So
• 24:50
  what's
• 24:50
  your
• 24:50
  view
• 24:50
  on
• 24:50
  that?
• 24:51
  So
• 24:51
  another
• 24:51
  one,
• 24:52
  again,
• 24:52
  you
• 24:52
  have
• 24:52
  to
• 24:52
  be
• 24:52
  very,
• 24:53
  very
• 24:53
  careful
• 24:53
  with
• 24:53
  is
• 24:54
  in
• 24:54
  some
• 24:54
  cases
• 24:55
  some
• 24:55
  people
• 24:55
  may
• 24:55
  get
• 24:56
  a
• 24:56
  regulatory
• 24:56
  approval
• 24:57
  for,
• 24:57
  let's
• 24:57
  just
• 24:57
  say
• 24:57
  a
• 24:57
  version
• 24:58
  one,
• 24:58
  but
• 24:58
  the
• 24:58
  product
• 24:59
  they
• 24:59
  actually
• 24:59
  go
• 24:59
  on
• 24:59
  to
• 24:59
  sell
• 24:59
  is
• 24:59
  actually
• 25:00
  the
• 25:00
  version
• 25:00
  three.
• 25:00
  Yeah.
• 25:00
  So
• 25:01
  what
• 25:01
  they
• 25:01
  do
• 25:01
  is
• 25:01
  once
• 25:02
  it's
• 25:02
  on
• 25:02
  the
• 25:02
  market,
• 25:03
  they
• 25:03
  submit
• 25:03
  what's
• 25:03
  known.
• 25:03
  Known
• 25:04
  is
• 25:04
  basically
• 25:04
  a
• 25:04
  substantial
• 25:05
  change.
• 25:06
  And
• 25:06
  that's
• 25:06
  the
• 25:06
  way
• 25:06
  I
• 25:06
  go
• 25:07
  around
• 25:07
  it.
• 25:07
  So
• 25:08
  if
• 25:08
  it
• 25:08
  is
• 25:08
  a
• 25:08
  circumstance,
• 25:09
  and
• 25:09
  I
• 25:09
  have
• 25:09
  seen
• 25:09
  some
• 25:09
  companies
• 25:10
  do
• 25:10
  this,
• 25:10
  whether
• 25:10
  that's
• 25:11
  an
• 25:11
  investor
• 25:11
  milestone
• 25:12
  or
• 25:12
  something
• 25:12
  like
• 25:12
  that,
• 25:12
  where
• 25:13
  they've
• 25:13
  had
• 25:13
  to
• 25:13
  release
• 25:14
  a
• 25:14
  version
• 25:14
  of
• 25:14
  the
• 25:14
  product
• 25:15
  whilst
• 25:15
  they're
• 25:15
  in
• 25:15
  the
• 25:16
  background.
• 25:16
  So
• 25:16
  what
• 25:16
  they
• 25:16
  do
• 25:16
  is
• 25:16
  they
• 25:17
  release
• 25:17
  that
• 25:17
  version
• 25:17
  of
• 25:17
  the
• 25:17
  product
• 25:18
  and
• 25:18
  they
• 25:18
  sell
• 25:18
  that
• 25:18
  which
• 25:18
  may
• 25:19
  have
• 25:19
  minimum
• 25:19
  sales,
• 25:20
  but
• 25:20
  then
• 25:20
  in
• 25:20
  the
• 25:20
  back
• 25:21
  they
• 25:21
  may
• 25:21
  be
• 25:21
  working
• 25:21
  on
• 25:21
  a
• 25:21
  V
• 25:22
  two
• 25:22
  or
• 25:22
  a
• 25:22
  V
• 25:22
  three,
• 25:23
  getting
• 25:23
  that
• 25:23
  extra
• 25:23
  clinical
• 25:24
  data
• 25:24
  whilst
• 25:24
  they're
• 25:25
  still
• 25:25
  getting
• 25:25
  sales
• 25:25
  on
• 25:25
  a
• 25:26
  lower
• 25:26
  volume.
• 25:26
  Yeah.
• 25:27
  Reality
• 25:27
  is
• 25:27
  the
• 25:27
  V
• 25:28
  three
• 25:28
  is
• 25:28
  a
• 25:28
  product
• 25:28
  that
• 25:28
  they
• 25:28
  wanted
• 25:29
  out
• 25:29
  on
• 25:29
  the
• 25:29
  market,
• 25:29
  but
• 25:30
  they
• 25:30
  released
• 25:30
  the
• 25:30
  V
• 25:30
  one,
• 25:31
  which
• 25:31
  is
• 25:31
  a
• 25:31
  sort
• 25:31
  of,
• 25:31
  let's
• 25:32
  just
• 25:32
  say
• 25:32
  a
• 25:32
  lesser
• 25:32
  claim
• 25:33
  version
• 25:33
  of
• 25:33
  it.
• 25:33
  Just
• 25:33
  to
• 25:34
  generate
• 25:34
  a
• 25:34
  bit
• 25:34
  of
• 25:34
  sales
• 25:35
  and
• 25:35
  get
• 25:35
  that
• 25:35
  sort
• 25:35
  of
• 25:35
  commercial
• 25:36
  approval.
• 25:36
  But
• 25:36
  reality
• 25:37
  is
• 25:37
  the
• 25:37
  aim
• 25:37
  has
• 25:38
  always
• 25:38
  been
• 25:38
  that
• 25:38
  sort
• 25:38
  of
• 25:38
  the
• 25:38
  V
• 25:39
  three
• 25:39
  of
• 25:39
  the
• 25:39
  product,
• 25:40
  so
• 25:40
  yeah.
• 25:40
  So
• 25:40
  your
• 25:40
  advice
• 25:41
  would
• 25:41
  be
• 25:41
  release
• 25:42
  the
• 25:42
  V
• 25:42
  one
• 25:43
  and
• 25:43
  do
• 25:43
  exactly
• 25:43
  what
• 25:43
  you've
• 25:44
  just
• 25:44
  described,
• 25:44
  rather
• 25:44
  than
• 25:45
  iterating,
• 25:45
  get
• 25:45
  to
• 25:45
  the
• 25:45
  V
• 25:46
  three,
• 25:46
  which
• 25:46
  is
• 25:46
  obviously
• 25:47
  gonna
• 25:47
  cost
• 25:47
  a
• 25:47
  lot
• 25:47
  more
• 25:47
  money
• 25:48
  because
• 25:48
  you've
• 25:48
  got
• 25:48
  no
• 25:48
  revenue
• 25:49
  coming
• 25:49
  in
• 25:49
  and
• 25:49
  then
• 25:49
  release
• 25:50
  the
• 25:50
  V
• 25:50
  three
• 25:50
  effectively.
• 25:51
  Yes.
• 25:51
  If
• 25:51
  there's
• 25:51
  still
• 25:52
  gonna
• 25:52
  be
• 25:52
  some
• 25:52
  sales
• 25:53
  for
• 25:53
  that
• 25:53
  V
• 25:53
  one,
• 25:53
  it
• 25:53
  may
• 25:53
  not
• 25:54
  be
• 25:54
  what
• 25:54
  we
• 25:54
  want,
• 25:54
  but
• 25:55
  of
• 25:55
  course
• 25:55
  if
• 25:55
  the
• 25:55
  V
• 25:55
  one's
• 25:55
  not
• 25:56
  gonna
• 25:56
  make
• 25:56
  any
• 25:56
  sales
• 25:57
  and
• 25:57
  you
• 25:57
  just
• 25:57
  sort
• 25:57
  of.
• 25:57
  Make
• 25:57
  the
• 25:57
  V
• 25:58
  one
• 25:58
  for
• 25:58
  the
• 25:58
  sake
• 25:58
  making
• 25:58
  the
• 25:59
  V
• 25:59
  one,
• 25:59
  then
• 25:59
  I
• 25:59
  don't
• 25:59
  think
• 26:00
  it's
• 26:00
  worth
• 26:00
  the
• 26:00
  time
• 26:00
  at
• 26:00
  all.
• 26:00
  Yeah,
• 26:01
  no,
• 26:01
  that,
• 26:01
  that
• 26:01
  makes
• 26:01
  sense.
• 26:02
  It
• 26:02
  is
• 26:02
  just
• 26:02
  lots
• 26:03
  of
• 26:03
  clinicians
• 26:03
  are.
• 26:03
  By
• 26:04
  virtue
• 26:04
  of
• 26:04
  the
• 26:04
  fact
• 26:04
  they're
• 26:04
  clinicians,
• 26:05
  I'm
• 26:05
  not,
• 26:06
  the
• 26:06
  kind
• 26:06
  of,
• 26:06
  I
• 26:06
  don't
• 26:06
  know,
• 26:06
  I
• 26:07
  dunno
• 26:07
  whether
• 26:07
  you
• 26:07
  describe
• 26:07
  'em
• 26:07
  as
• 26:08
  perfectionist
• 26:08
  or
• 26:08
  procrastinators,
• 26:09
  but
• 26:10
  they're
• 26:10
  in
• 26:10
  between
• 26:10
  one
• 26:10
  of
• 26:10
  those
• 26:11
  two.
• 26:11
  So
• 26:11
  they're
• 26:11
  like,
• 26:12
  oh,
• 26:12
  well
• 26:12
  we,
• 26:12
  we've
• 26:13
  got
• 26:13
  this
• 26:13
  feedback,
• 26:13
  so
• 26:13
  we
• 26:13
  don't
• 26:14
  wanna
• 26:14
  do
• 26:14
  anything.
• 26:14
  Let's
• 26:14
  do
• 26:14
  a
• 26:15
  bit
• 26:15
  more
• 26:15
  feedback
• 26:15
  and
• 26:15
  a
• 26:15
  bit
• 26:16
  more.
• 26:16
  And
• 26:16
  you're
• 26:16
  thinking.
• 26:16
  You
• 26:16
  do
• 26:17
  know
• 26:17
  you're
• 26:17
  not
• 26:17
  making
• 26:17
  any
• 26:17
  cash
• 26:18
  at
• 26:18
  the
• 26:18
  moment,
• 26:18
  and
• 26:18
  you're
• 26:19
  burning
• 26:19
  through
• 26:19
  cash.
• 26:19
  So
• 26:20
  you
• 26:20
  do
• 26:20
  need
• 26:20
  to
• 26:20
  have,
• 26:21
  which
• 26:21
  is
• 26:21
  the
• 26:21
  whole
• 26:21
  point
• 26:21
  of
• 26:21
  this,
• 26:22
  is
• 26:22
  have
• 26:22
  some
• 26:22
  sort
• 26:23
  of
• 26:23
  platform
• 26:23
  or
• 26:23
  some
• 26:23
  sort
• 26:24
  of
• 26:24
  pathway
• 26:24
  to
• 26:24
  commercialization
• 26:26
  whilst
• 26:26
  you're
• 26:26
  doing
• 26:26
  the
• 26:26
  regulatory
• 26:27
  'cause
• 26:27
  the
• 26:27
  regulation's
• 26:27
  gonna
• 26:27
  cost
• 26:28
  you.
• 26:28
  So
• 26:28
  you
• 26:28
  need
• 26:28
  to
• 26:28
  know,
• 26:29
  right?
• 26:29
  Well,
• 26:30
  this
• 26:30
  is
• 26:30
  where
• 26:30
  if
• 26:30
  we're
• 26:30
  gonna
• 26:31
  spend
• 26:31
  that
• 26:31
  money,
• 26:31
  this
• 26:32
  is
• 26:32
  what
• 26:32
  we
• 26:32
  need
• 26:32
  to
• 26:32
  do
• 26:32
  to
• 26:33
  recoup
• 26:33
  that
• 26:33
  and
• 26:34
  actually
• 26:34
  make
• 26:35
  ourselves
• 26:35
  a
• 26:35
  viable
• 26:36
  business.
• 26:37
  So.
• 26:37
  And
• 26:37
  then
• 26:37
  in
• 26:38
  terms
• 26:38
  of,
• 26:38
  measure
• 26:39
  the
• 26:39
  success,
• 26:39
  commercial
• 26:40
  measures,
• 26:40
  the
• 26:40
  success
• 26:40
  are
• 26:40
  very
• 26:41
  easy.
• 26:41
  you're
• 26:41
  either
• 26:41
  making
• 26:41
  money
• 26:42
  or
• 26:42
  you're
• 26:42
  not.
• 26:42
  You're
• 26:42
  either
• 26:42
  hitting
• 26:42
  your
• 26:43
  targets
• 26:43
  or
• 26:43
  you're
• 26:43
  not.
• 26:44
  How
• 26:44
  do
• 26:44
  you
• 26:44
  specifically
• 26:45
  measure
• 26:45
  the
• 26:46
  success
• 26:46
  of
• 26:46
  a
• 26:46
  product?
• 26:47
  When
• 26:47
  you're
• 26:47
  talking
• 26:47
  about
• 26:48
  relating
• 26:48
  that
• 26:48
  to
• 26:49
  its
• 26:49
  regulatory
• 26:49
  approval
• 26:50
  timeline,
• 26:50
  is
• 26:50
  there
• 26:50
  anything
• 26:51
  that
• 26:51
  you
• 26:51
  look
• 26:51
  at
• 26:51
  to
• 26:52
  say,
• 26:52
  yeah,
• 26:52
  this
• 26:52
  has
• 26:52
  been
• 26:52
  successful,
• 26:53
  alongside
• 26:54
  the
• 26:54
  commercials
• 26:55
  or
• 26:55
  not?
• 26:55
  Yeah.
• 26:56
  So
• 26:56
  having
• 26:56
  reviewed
• 26:56
  a
• 26:56
  pitch
• 26:57
  deck
• 26:57
  of
• 26:57
  a
• 26:57
  few
• 26:58
  companies,
• 26:58
  I
• 26:59
  think
• 26:59
  that
• 26:59
  days
• 26:59
  clearance
• 27:00
  is
• 27:00
  nothing
• 27:00
  but
• 27:00
  a
• 27:00
  vanity
• 27:01
  metric.
• 27:01
  When
• 27:01
  a
• 27:01
  company
• 27:02
  say
• 27:02
  something
• 27:02
  like,
• 27:02
  it
• 27:02
  took
• 27:03
  us
• 27:03
  180
• 27:03
  days
• 27:03
  to
• 27:04
  get
• 27:04
  to
• 27:04
  the
• 27:04
  market,
• 27:04
  or
• 27:04
  150
• 27:05
  days
• 27:05
  to
• 27:05
  get
• 27:05
  to
• 27:05
  the
• 27:05
  market,
• 27:06
  which
• 27:06
  is
• 27:06
  fine,
• 27:06
  but
• 27:07
  the
• 27:07
  ones
• 27:07
  that
• 27:07
  really
• 27:07
  matter
• 27:08
  is
• 27:08
  the
• 27:08
  time
• 27:09
  it
• 27:09
  takes
• 27:09
  from
• 27:09
  that
• 27:09
  regulatory
• 27:10
  approval
• 27:10
  to
• 27:11
  get
• 27:11
  that
• 27:11
  first
• 27:11
  customer.
• 27:12
  I
• 27:12
  think
• 27:12
  that's
• 27:12
  way
• 27:13
  more
• 27:13
  of
• 27:13
  an
• 27:13
  important
• 27:13
  metric,
• 27:14
  even
• 27:14
  if
• 27:14
  it
• 27:14
  took
• 27:14
  you
• 27:14
  three
• 27:15
  years
• 27:15
  to
• 27:15
  get
• 27:15
  your
• 27:15
  product
• 27:16
  onto
• 27:16
  the
• 27:16
  market.
• 27:16
  The
• 27:16
  metric
• 27:17
  that
• 27:17
  I'm
• 27:17
  gonna
• 27:17
  be
• 27:17
  looking
• 27:18
  for
• 27:18
  is
• 27:18
  at
• 27:18
  the
• 27:18
  point
• 27:18
  of
• 27:19
  when
• 27:19
  was
• 27:19
  you
• 27:19
  allowed
• 27:19
  to
• 27:19
  legally
• 27:20
  sell
• 27:20
  it
• 27:20
  and
• 27:20
  when
• 27:21
  did
• 27:21
  you
• 27:21
  get
• 27:21
  that
• 27:21
  first
• 27:21
  customer?
• 27:22
  The
• 27:22
  smaller
• 27:22
  that
• 27:22
  gap,
• 27:23
  that
• 27:23
  tells
• 27:23
  me
• 27:24
  the
• 27:24
  more
• 27:24
  need
• 27:24
  there
• 27:24
  was
• 27:24
  from
• 27:25
  your
• 27:25
  product
• 27:25
  and
• 27:25
  the
• 27:25
  more
• 27:25
  you
• 27:25
  did
• 27:26
  from
• 27:26
  a
• 27:26
  health
• 27:26
  economic
• 27:26
  side
• 27:27
  as
• 27:27
  well.
• 27:27
  Another
• 27:27
  metric
• 27:28
  I'll
• 27:28
  be
• 27:28
  looking
• 27:28
  at
• 27:29
  is
• 27:29
  your
• 27:29
  revenue
• 27:29
  at
• 27:30
  12
• 27:30
  months
• 27:30
  and
• 27:30
  24
• 27:31
  months
• 27:31
  post
• 27:32
  approval.
• 27:32
  Those
• 27:33
  are
• 27:33
  the
• 27:33
  very
• 27:33
  important
• 27:34
  numbers.
• 27:34
  And
• 27:34
  then
• 27:34
  that
• 27:35
  will
• 27:35
  tell
• 27:35
  me
• 27:35
  straight
• 27:35
  away
• 27:36
  is
• 27:36
  that
• 27:36
  you
• 27:36
  not
• 27:37
  just
• 27:37
  had
• 27:37
  a
• 27:37
  strong
• 27:37
  regulatory
• 27:38
  strategy,
• 27:38
  but
• 27:39
  you
• 27:39
  also
• 27:39
  had
• 27:39
  a
• 27:39
  strong
• 27:40
  commercial
• 27:40
  strategy
• 27:41
  and
• 27:41
  you
• 27:41
  had
• 27:41
  all
• 27:41
  your
• 27:41
  docs
• 27:42
  aligned
• 27:42
  effectively.
• 27:43
  And
• 27:43
  it's
• 27:43
  interesting.
• 27:44
  This
• 27:44
  is
• 27:44
  obviously
• 27:44
  why
• 27:44
  I've
• 27:45
  got
• 27:45
  you
• 27:45
  on
• 27:45
  'cause
• 27:45
  you're
• 27:45
  very
• 27:46
  commercial.
• 27:46
  Do
• 27:46
  you
• 27:46
  think
• 27:47
  that
• 27:47
  many
• 27:48
  regulatory
• 27:48
  people.
• 27:49
  It's
• 27:49
  a
• 27:49
  leading
• 27:49
  question
• 27:49
  really,
• 27:50
  but
• 27:50
  do
• 27:50
  you
• 27:50
  think
• 27:50
  there's
• 27:50
  that
• 27:51
  many
• 27:51
  regulatory
• 27:51
  people
• 27:52
  who
• 27:52
  are
• 27:52
  thinking
• 27:52
  like
• 27:53
  you?
• 27:53
  I
• 27:53
  don't
• 27:53
  think
• 27:53
  so,
• 27:54
  and
• 27:54
  I
• 27:54
  think
• 27:54
  what
• 27:54
  makes
• 27:54
  me
• 27:55
  different
• 27:55
  is
• 27:55
  sort
• 27:55
  of
• 27:56
  being
• 27:56
  a
• 27:56
  consultant.
• 27:57
  And
• 27:57
  again,
• 27:57
  it's
• 27:57
  not
• 27:58
  just
• 27:58
  regulatory.
• 27:58
  Also,
• 27:59
  startup
• 27:59
  advisor
• 28:00
  and
• 28:00
  I
• 28:00
  work
• 28:00
  with
• 28:01
  different
• 28:01
  companies,
• 28:01
  so
• 28:01
  I
• 28:02
  get
• 28:02
  to
• 28:02
  see
• 28:02
  things
• 28:02
  from
• 28:03
  a
• 28:03
  many
• 28:03
  different
• 28:04
  lens.
• 28:04
  Now,
• 28:04
  the
• 28:05
  problem
• 28:05
  is
• 28:05
  with
• 28:06
  regulatory,
• 28:06
  and
• 28:07
  it's
• 28:07
  due
• 28:07
  to
• 28:08
  the
• 28:08
  nature
• 28:08
  of
• 28:08
  the
• 28:08
  role.
• 28:08
  Sometimes
• 28:09
  they
• 28:09
  just
• 28:09
  don't
• 28:10
  get
• 28:10
  this
• 28:10
  exposure.
• 28:11
  Yeah,
• 28:11
  so
• 28:11
  particularly
• 28:11
  for
• 28:11
  those
• 28:12
  in
• 28:12
  permanent
• 28:13
  roles,
• 28:13
  and
• 28:13
  I
• 28:13
  remember
• 28:13
  when
• 28:13
  I
• 28:13
  was
• 28:14
  in
• 28:14
  permanent
• 28:14
  roles,
• 28:14
  I'm
• 28:14
  not
• 28:15
  saying
• 28:15
  anything
• 28:15
  against
• 28:16
  them,
• 28:16
  but
• 28:16
  sometimes
• 28:16
  you
• 28:16
  are
• 28:16
  just
• 28:17
  that
• 28:17
  regulatory
• 28:17
  department
• 28:18
  and
• 28:18
  you
• 28:18
  don't
• 28:18
  know
• 28:18
  why
• 28:19
  certain
• 28:19
  claims
• 28:19
  are
• 28:19
  being
• 28:20
  made
• 28:20
  and
• 28:20
  you
• 28:20
  don't
• 28:20
  really
• 28:20
  get
• 28:21
  to
• 28:21
  speak
• 28:21
  to
• 28:21
  commercial
• 28:22
  and
• 28:22
  that
• 28:22
  sort
• 28:22
  of
• 28:22
  thing.
• 28:22
  I
• 28:23
  think
• 28:23
  that's
• 28:23
  what
• 28:23
  it
• 28:23
  is
• 28:23
  in
• 28:23
  majority
• 28:24
  of
• 28:24
  regulatory
• 28:24
  roles
• 28:25
  are
• 28:25
  unfortunately,
• 28:25
  particularly
• 28:26
  in
• 28:26
  bigger
• 28:26
  multinationals,
• 28:27
  is
• 28:27
  they
• 28:27
  just
• 28:27
  don't
• 28:27
  get
• 28:28
  that
• 28:28
  exposure.
• 28:28
  So
• 28:28
  they
• 28:29
  don't
• 28:29
  get
• 28:29
  this
• 28:29
  understanding
• 28:30
  of,
• 28:30
  ah,
• 28:30
  that's
• 28:30
  how
• 28:30
  commercial
• 28:31
  works,
• 28:31
  or
• 28:31
  that
• 28:31
  education,
• 28:32
  I
• 28:32
  think,
• 28:32
  as
• 28:33
  consultants
• 28:33
  is
• 28:33
  a
• 28:33
  bit
• 28:34
  different
• 28:34
  because
• 28:34
  we
• 28:35
  are
• 28:35
  sort
• 28:35
  of
• 28:35
  brought
• 28:35
  in
• 28:35
  at
• 28:35
  the
• 28:35
  latest
• 28:35
  stages.
• 28:36
  We
• 28:36
  could
• 28:36
  speak
• 28:36
  directly
• 28:37
  with
• 28:37
  investors.
• 28:38
  That
• 28:38
  sort
• 28:38
  of
• 28:38
  thing.
• 28:38
  So
• 28:39
  my
• 28:39
  view
• 28:39
  here
• 28:39
  is
• 28:40
  if
• 28:40
  you
• 28:40
  are
• 28:40
  in
• 28:40
  one
• 28:40
  of
• 28:40
  those
• 28:40
  kind
• 28:41
  of
• 28:41
  roles
• 28:41
  where
• 28:41
  you,
• 28:41
  and
• 28:42
  not
• 28:42
  getting
• 28:42
  the
• 28:42
  exposure,
• 28:43
  see
• 28:43
  if
• 28:43
  there's
• 28:43
  any
• 28:44
  sort
• 28:44
  of
• 28:44
  boards
• 28:44
  that
• 28:45
  you
• 28:45
  can
• 28:45
  join,
• 28:45
  any
• 28:46
  professional
• 28:46
  bodies
• 28:46
  or
• 28:47
  anything
• 28:47
  like
• 28:47
  that.
• 28:47
  And
• 28:47
  that's
• 28:48
  a
• 28:48
  way
• 28:48
  to
• 28:48
  sort
• 28:48
  of
• 28:48
  get
• 28:48
  into
• 28:49
  this
• 28:49
  thinking.
• 28:49
  But
• 28:49
  to
• 28:49
  answer
• 28:50
  that
• 28:50
  question,
• 28:50
  the
• 28:50
  answer
• 28:51
  is
• 28:51
  no
• 28:51
  money
• 28:52
  to
• 28:52
  regulatory
• 28:52
  people
• 28:52
  don't,
• 28:53
  and
• 28:53
  it's
• 28:53
  simply
• 28:53
  because
• 28:54
  they
• 28:54
  don't
• 28:54
  get
• 28:54
  the,
• 28:54
  this
• 28:54
  kind
• 28:55
  of
• 28:55
  exposure.
• 28:55
  Yeah.
• 28:56
  And
• 28:56
  my
• 28:56
  advice
• 28:56
  to
• 28:56
  my
• 28:56
  listeners
• 28:57
  would
• 28:57
  be
• 28:58
  quite
• 28:58
  simply,
• 28:58
  if
• 28:59
  you
• 28:59
  are,
• 28:59
  in
• 28:59
  a
• 28:59
  startup
• 29:00
  phase,
• 29:00
  and
• 29:00
  even
• 29:00
  if
• 29:01
  you're
• 29:01
  not
• 29:01
  in
• 29:01
  a
• 29:01
  startup
• 29:01
  phase,
• 29:01
  but
• 29:01
  if
• 29:01
  you're
• 29:01
  in
• 29:02
  the
• 29:02
  startup
• 29:02
  phase
• 29:02
  and
• 29:02
  you're
• 29:02
  thinking
• 29:03
  that
• 29:03
  actually
• 29:03
  you
• 29:03
  need
• 29:03
  some
• 29:04
  decent
• 29:04
  regulatory
• 29:04
  support,
• 29:05
  you
• 29:05
  do
• 29:05
  need
• 29:05
  to
• 29:05
  look
• 29:05
  for
• 29:06
  somebody
• 29:06
  like
• 29:06
  Karen
• 29:06
  Deep,
• 29:07
  who
• 29:07
  is
• 29:07
  commercial
• 29:08
  because
• 29:08
  in
• 29:08
  startups
• 29:09
  specifically,
• 29:10
  if
• 29:10
  even
• 29:10
  more
• 29:11
  important
• 29:11
  that
• 29:12
  commercial
• 29:12
  and
• 29:12
  regulatory
• 29:13
  work
• 29:13
  together,
• 29:13
  'cause
• 29:13
  it's
• 29:14
  small,
• 29:14
  you've
• 29:14
  got
• 29:14
  an
• 29:15
  opportunity
• 29:15
  to
• 29:15
  do
• 29:15
  it
• 29:16
  and
• 29:16
  you
• 29:16
  haven't
• 29:17
  got
• 29:17
  as
• 29:17
  much
• 29:17
  money.
• 29:17
  So
• 29:18
  it
• 29:18
  is
• 29:18
  important
• 29:18
  'cause,
• 29:18
  it's
• 29:19
  very
• 29:19
  rare
• 29:19
  for
• 29:19
  me
• 29:20
  to
• 29:20
  speak
• 29:20
  to
• 29:20
  a
• 29:20
  regulatory
• 29:21
  person,
• 29:21
  and
• 29:21
  they're
• 29:21
  talking
• 29:22
  about
• 29:22
  the
• 29:22
  time
• 29:22
  from
• 29:23
  regulatory
• 29:23
  approval
• 29:23
  to
• 29:23
  first,
• 29:24
  sale
• 29:24
  or
• 29:25
  sales,
• 29:26
  12
• 29:26
  months,
• 29:27
  24
• 29:27
  months.
• 29:27
  Most
• 29:28
  regulatory
• 29:28
  people
• 29:29
  that
• 29:29
  I'll
• 29:29
  speak
• 29:29
  to
• 29:29
  are
• 29:29
  just
• 29:29
  talk.
• 29:30
  They've
• 29:30
  got
• 29:30
  the
• 29:30
  head
• 29:30
  in
• 29:30
  the
• 29:31
  detail
• 29:31
  of
• 29:31
  the
• 29:31
  regulatory.
• 29:32
  They're
• 29:32
  not
• 29:32
  asking
• 29:32
  those,
• 29:33
  they're
• 29:33
  not
• 29:33
  asking
• 29:33
  those
• 29:33
  commercial
• 29:34
  questions.
• 29:34
  And
• 29:34
  that's
• 29:34
  where
• 29:35
  a
• 29:35
  lot
• 29:36
  of
• 29:36
  issues,
• 29:37
  go
• 29:37
  bad.
• 29:38
  Because
• 29:38
  then
• 29:39
  what
• 29:39
  you're
• 29:39
  looking
• 29:39
  at
• 29:39
  is,
• 29:40
  I've
• 29:40
  got
• 29:40
  a
• 29:40
  regulatory
• 29:40
  person.
• 29:41
  Who
• 29:41
  I
• 29:41
  might
• 29:41
  have
• 29:41
  brought
• 29:42
  in
• 29:42
  late
• 29:42
  and
• 29:43
  then
• 29:43
  spend
• 29:43
  them
• 29:43
  a
• 29:43
  lot
• 29:43
  of
• 29:43
  money
• 29:44
  to
• 29:44
  fix
• 29:44
  that
• 29:44
  out.
• 29:44
  Then
• 29:45
  it's
• 29:45
  almost
• 29:45
  like
• 29:46
  a
• 29:46
  linear
• 29:46
  process.
• 29:46
  They'll
• 29:47
  see
• 29:47
  it
• 29:47
  after
• 29:47
  them
• 29:47
  moving
• 29:48
  on
• 29:48
  and
• 29:48
  saying,
• 29:48
  right,
• 29:48
  I've
• 29:48
  got
• 29:48
  the
• 29:48
  regulatory,
• 29:49
  now
• 29:49
  I
• 29:49
  need
• 29:49
  to
• 29:49
  go
• 29:49
  and
• 29:49
  get
• 29:49
  another
• 29:50
  commercial
• 29:50
  person.
• 29:51
  And
• 29:51
  the
• 29:51
  commercial
• 29:51
  person
• 29:52
  then
• 29:52
  saying,
• 29:52
  oh,
• 29:52
  but
• 29:52
  you
• 29:52
  haven't
• 29:53
  done
• 29:53
  this.
• 29:53
  You
• 29:53
  haven't
• 29:53
  done
• 29:53
  that,
• 29:53
  and
• 29:54
  then
• 29:54
  they're
• 29:54
  going
• 29:54
  back
• 29:54
  to
• 29:54
  it.
• 29:54
  So
• 29:55
  just
• 29:55
  become
• 29:55
  the
• 29:55
  vicious
• 29:55
  cycle
• 29:56
  as
• 29:56
  opposed
• 29:56
  to
• 29:56
  when
• 29:56
  you
• 29:56
  do
• 29:57
  it
• 29:57
  together,
• 29:57
  it
• 29:57
  might
• 29:58
  be
• 29:58
  initially
• 29:58
  more
• 29:59
  expensive.
• 29:59
  But
• 29:59
  I
• 30:00
  can
• 30:00
  guarantee
• 30:00
  over
• 30:00
  the
• 30:00
  long
• 30:01
  term
• 30:01
  it'll
• 30:01
  be
• 30:01
  much
• 30:02
  more
• 30:02
  cost
• 30:02
  effective
• 30:03
  and
• 30:03
  more
• 30:03
  importantly,
• 30:04
  that
• 30:04
  12
• 30:05
  month
• 30:05
  and
• 30:05
  24
• 30:05
  month
• 30:06
  post
• 30:06
  regulatory
• 30:07
  approval
• 30:07
  is
• 30:07
  gonna
• 30:08
  be
• 30:08
  looking
• 30:08
  much
• 30:08
  better
• 30:09
  than
• 30:09
  when
• 30:09
  you
• 30:09
  do
• 30:09
  it
• 30:10
  piecemeal
• 30:10
  and
• 30:10
  you're
• 30:10
  doing
• 30:11
  little
• 30:11
  bits
• 30:11
  here
• 30:11
  because
• 30:12
  you
• 30:12
  think,
• 30:12
  oh,
• 30:12
  it's
• 30:12
  a
• 30:12
  bit
• 30:12
  cheaper
• 30:13
  for
• 30:13
  me
• 30:13
  just
• 30:13
  to
• 30:13
  get
• 30:13
  a
• 30:14
  regulatory
• 30:14
  person
• 30:15
  who
• 30:15
  just
• 30:15
  get
• 30:15
  gets
• 30:16
  me
• 30:16
  those
• 30:16
  certificates.
• 30:17
  So
• 30:17
  I
• 30:17
  think
• 30:17
  that's
• 30:17
  a
• 30:18
  really
• 30:18
  important,
• 30:18
  piece
• 30:19
  of
• 30:19
  advice
• 30:19
  there.
• 30:19
  So.
• 30:20
  In
• 30:20
  terms
• 30:21
  of
• 30:21
  final
• 30:21
  question,
• 30:22
  if,
• 30:22
  and
• 30:23
  I'm
• 30:23
  sure
• 30:23
  everyone's
• 30:23
  listened
• 30:23
  to
• 30:24
  every
• 30:24
  word
• 30:24
  that
• 30:24
  we've
• 30:24
  said
• 30:25
  all
• 30:25
  the
• 30:25
  way
• 30:25
  through,
• 30:25
  if
• 30:25
  there
• 30:25
  was
• 30:26
  like
• 30:26
  one
• 30:27
  piece
• 30:27
  of
• 30:27
  advice
• 30:28
  that
• 30:28
  you
• 30:28
  could
• 30:29
  give,
• 30:29
  'cause
• 30:30
  someone's
• 30:30
  just
• 30:30
  jumped
• 30:30
  in
• 30:30
  at
• 30:31
  the
• 30:31
  end,
• 30:31
  I
• 30:31
  don't
• 30:31
  know
• 30:31
  why
• 30:31
  they
• 30:31
  would.
• 30:32
  One
• 30:32
  piece
• 30:32
  of
• 30:32
  advice
• 30:33
  that
• 30:33
  you
• 30:33
  could
• 30:33
  give
• 30:34
  to
• 30:34
  a
• 30:34
  start
• 30:34
  Founder
• 30:35
  who
• 30:35
  prior
• 30:36
  to
• 30:36
  this
• 30:36
  call
• 30:37
  we're
• 30:37
  thinking,
• 30:37
  I
• 30:37
  just
• 30:37
  need
• 30:38
  to
• 30:38
  get
• 30:38
  regulation,
• 30:39
  sorted,
• 30:39
  and
• 30:40
  then
• 30:40
  I'll
• 30:40
  think
• 30:40
  about
• 30:40
  commercial.
• 30:41
  What
• 30:41
  would
• 30:41
  your
• 30:42
  advice
• 30:42
  be?
• 30:42
  My
• 30:42
  advice
• 30:43
  here
• 30:43
  will
• 30:43
  be
• 30:44
  to
• 30:44
  go
• 30:44
  out
• 30:44
  and
• 30:44
  talk
• 30:45
  to,
• 30:45
  let's
• 30:45
  just
• 30:46
  say
• 30:46
  10.
• 30:47
  10
• 30:47
  customers.
• 30:48
  And
• 30:48
  this
• 30:48
  is
• 30:48
  not
• 30:48
  10
• 30:49
  end
• 30:49
  users,
• 30:49
  not
• 30:50
  10
• 30:50
  physicians,
• 30:50
  not
• 30:51
  10
• 30:51
  subject
• 30:51
  matter
• 30:52
  experts,
• 30:52
  but
• 30:52
  10
• 30:53
  actual
• 30:53
  customers
• 30:53
  who's
• 30:54
  actually
• 30:54
  gonna
• 30:54
  be
• 30:54
  buying
• 30:55
  from
• 30:55
  you
• 30:55
  and
• 30:55
  see
• 30:56
  if
• 30:56
  they
• 30:56
  will
• 30:56
  be
• 30:56
  interested
• 30:57
  in
• 30:57
  your
• 30:57
  type
• 30:58
  of
• 30:58
  product.
• 30:58
  And
• 30:58
  what
• 30:58
  I
• 30:59
  mean
• 30:59
  by
• 30:59
  this
• 30:59
  is
• 30:59
  how
• 31:00
  does
• 31:00
  that
• 31:00
  buyer
• 31:00
  go
• 31:01
  about
• 31:01
  qualifying
• 31:01
  a
• 31:01
  product?
• 31:02
  What
• 31:02
  is
• 31:02
  their
• 31:02
  search
• 31:03
  process
• 31:03
  looking
• 31:03
  like?
• 31:04
  Would
• 31:04
  your
• 31:04
  product
• 31:04
  even
• 31:05
  come
• 31:05
  into
• 31:05
  the
• 31:05
  picture
• 31:05
  based
• 31:06
  on
• 31:06
  the
• 31:06
  criteria
• 31:06
  of
• 31:07
  which
• 31:07
  they're
• 31:07
  searching?
• 31:07
  How
• 31:08
  do
• 31:08
  they
• 31:08
  go
• 31:08
  about
• 31:08
  finding
• 31:08
  these
• 31:09
  kind
• 31:09
  of
• 31:09
  products?
• 31:10
  Do
• 31:10
  they
• 31:10
  have
• 31:10
  to
• 31:10
  go
• 31:10
  through
• 31:10
  third
• 31:11
  parties?
• 31:11
  Is
• 31:11
  there
• 31:11
  a
• 31:11
  contract
• 31:12
  process?
• 31:13
  That
• 31:13
  is
• 31:13
  what
• 31:13
  you
• 31:13
  need
• 31:13
  to
• 31:13
  be
• 31:14
  looking
• 31:14
  at.
• 31:14
  Looking
• 31:14
  the
• 31:14
  way
• 31:15
  in
• 31:15
  which
• 31:15
  buyers
• 31:15
  search
• 31:16
  for
• 31:16
  products
• 31:16
  and
• 31:17
  products
• 31:17
  end
• 31:17
  up
• 31:17
  on
• 31:17
  their
• 31:18
  radar,
• 31:18
  and
• 31:18
  at
• 31:18
  that
• 31:19
  point
• 31:19
  you
• 31:19
  can
• 31:19
  then
• 31:19
  work
• 31:19
  with
• 31:20
  them
• 31:20
  and
• 31:20
  see
• 31:20
  if
• 31:20
  your
• 31:20
  product's
• 31:20
  economically
• 31:21
  viable
• 31:22
  or
• 31:22
  not.
• 31:22
  Not
• 31:22
  just
• 31:22
  because
• 31:23
  your
• 31:23
  product's
• 31:23
  fantastic
• 31:24
  or
• 31:24
  your
• 31:24
  technology's
• 31:25
  fantastic,
• 31:25
  because
• 31:26
  that
• 31:26
  doesn't
• 31:26
  guarantee
• 31:26
  sales.
• 31:27
  Thank
• 31:27
  you
• 31:27
  very
• 31:27
  much.
• 31:28
  I
• 31:28
  think
• 31:28
  that's,
• 31:28
  a
• 31:28
  perfect
• 31:29
  place
• 31:29
  on
• 31:29
  which
• 31:30
  to
• 31:30
  stop.
• 31:30
  I
• 31:30
  think
• 31:30
  it's
• 31:31
  very
• 31:31
  clear
• 31:31
  that
• 31:32
  regulatory
• 31:32
  and
• 31:33
  commercial,
• 31:33
  as
• 31:33
  Karen
• 31:34
  Beep
• 31:34
  said,
• 31:34
  right
• 31:34
  at
• 31:34
  the
• 31:34
  beginning,
• 31:35
  are
• 31:36
  a
• 31:36
  single
• 31:36
  stream
• 31:37
  and
• 31:37
  two
• 31:37
  sides
• 31:37
  of
• 31:38
  that
• 31:38
  stream.
• 31:38
  And
• 31:39
  doing
• 31:39
  one
• 31:39
  without
• 31:39
  the
• 31:39
  other
• 31:40
  is
• 31:40
  gonna
• 31:40
  lead
• 31:41
  to
• 31:41
  a
• 31:41
  whole
• 31:41
  lot
• 31:41
  of
• 31:41
  problems
• 31:42
  in
• 31:42
  the
• 31:42
  future.
• 31:43
  If
• 31:43
  you
• 31:43
  do
• 31:43
  commercial
• 31:43
  without
• 31:44
  regulatory.
• 31:45
  At
• 31:45
  some
• 31:45
  point,
• 31:45
  you're
• 31:45
  gonna,
• 31:46
  you
• 31:46
  might
• 31:46
  have
• 31:46
  a
• 31:46
  recall.
• 31:47
  You
• 31:47
  might
• 31:47
  have
• 31:47
  to
• 31:48
  stop
• 31:48
  selling
• 31:48
  it.
• 31:48
  And
• 31:48
  if
• 31:48
  you
• 31:48
  want
• 31:48
  to
• 31:49
  sell
• 31:49
  the
• 31:49
  business,
• 31:50
  as
• 31:50
  currently
• 31:50
  said,
• 31:50
  investors,
• 31:51
  and
• 31:51
  therefore
• 31:52
  people
• 31:52
  who
• 31:52
  wanna
• 31:52
  buy
• 31:53
  the
• 31:53
  business
• 31:53
  are
• 31:54
  gonna
• 31:54
  be
• 31:54
  looking
• 31:54
  at
• 31:54
  regulatory.
• 31:55
  And
• 31:55
  if
• 31:55
  your
• 31:55
  regulatory
• 31:55
  isn't
• 31:55
  on
• 31:56
  point,
• 31:56
  that
• 31:56
  could
• 31:56
  completely
• 31:57
  derail
• 31:58
  any
• 31:58
  purchase.
• 31:58
  And
• 31:59
  conversely,
• 31:59
  if
• 32:00
  you
• 32:00
  do
• 32:00
  regulatory
• 32:00
  without
• 32:01
  the
• 32:01
  commercial.
• 32:01
  You
• 32:01
  may
• 32:02
  have
• 32:02
  a
• 32:02
  fantastic
• 32:03
  product
• 32:04
  in
• 32:04
  your
• 32:04
  eyes,
• 32:05
  which
• 32:06
  have
• 32:06
  all
• 32:06
  of
• 32:06
  the
• 32:06
  regulatory
• 32:07
  certificates,
• 32:08
  but
• 32:08
  you
• 32:08
  can't
• 32:08
  sell
• 32:08
  it.
• 32:08
  And
• 32:09
  at
• 32:09
  the
• 32:09
  end
• 32:09
  of
• 32:09
  the
• 32:09
  day,
• 32:09
  your
• 32:10
  business
• 32:10
  is
• 32:10
  a
• 32:10
  commercial
• 32:11
  entity
• 32:11
  and
• 32:11
  that
• 32:12
  the
• 32:12
  end
• 32:12
  game
• 32:13
  and
• 32:13
  the
• 32:13
  end
• 32:13
  point
• 32:14
  is
• 32:14
  to
• 32:14
  deliver
• 32:14
  that.
• 32:15
  So
• 32:15
  thank
• 32:15
  you
• 32:15
  very
• 32:15
  much
• 32:15
  for
• 32:15
  your
• 32:15
  time,
• 32:16
  Karen.
• 32:16
  Deep.
• 32:16
  And
• 32:17
  now
• 32:17
  onto
• 32:18
  the
• 32:18
  decision
• 32:18
  making
• 32:19
  scenario
• 32:19
  for
• 32:20
  this
• 32:20
  episode,
• 32:22
  which
• 32:22
  Karen
• 32:22
  Deep
• 32:22
  will
• 32:23
  answer,
• 32:24
  and
• 32:24
  then
• 32:24
  we'll
• 32:24
  go
• 32:24
  through
• 32:25
  the
• 32:25
  answer
• 32:26
  on
• 32:26
  the
• 32:26
  next
• 32:27
  episode.
• 32:27
  So
• 32:28
  imagine
• 32:28
  you
• 32:29
  are
• 32:29
  guiding
• 32:29
  a
• 32:29
  MedTech
• 32:30
  startup
• 32:30
  that's
• 32:30
  progressing
• 32:31
  through
• 32:31
  regulatory
• 32:32
  approval
• 32:32
  for
• 32:32
  that
• 32:32
  device,
• 32:33
  early
• 32:34
  signal,
• 32:34
  the
• 32:34
  positive.
• 32:35
  But
• 32:35
  they
• 32:35
  have
• 32:35
  not
• 32:35
  yet
• 32:36
  developed
• 32:36
  a
• 32:36
  clear
• 32:36
  commercial
• 32:37
  strategy
• 32:38
  for
• 32:38
  market
• 32:38
  entry.
• 32:39
  Do
• 32:39
  you
• 32:39
  a
• 32:40
  focus
• 32:40
  solely
• 32:41
  on
• 32:41
  refining
• 32:41
  the
• 32:42
  products
• 32:42
  based
• 32:42
  on
• 32:42
  feedback
• 32:43
  from
• 32:43
  regulatory
• 32:43
  authorities?
• 32:44
  Before
• 32:45
  considering
• 32:45
  market
• 32:45
  entry,
• 32:46
  do
• 32:46
  you
• 32:46
  B
• 32:47
  launch
• 32:47
  the
• 32:47
  products
• 32:47
  immediately
• 32:48
  to
• 32:48
  capitalize
• 32:48
  on
• 32:48
  regulatory
• 32:49
  approval,
• 32:49
  even
• 32:50
  with
• 32:50
  minimal
• 32:51
  market
• 32:51
  analysis?
• 32:52
  Do
• 32:52
  you
• 32:52
  see
• 32:53
  developer
• 32:53
  comprehensive
• 32:54
  commercial
• 32:54
  strategy
• 32:54
  parallel
• 32:55
  to
• 32:55
  ongoing
• 32:55
  regulatory
• 32:56
  processes
• 32:56
  to
• 32:57
  ensure
• 32:57
  market
• 32:57
  readiness?
• 32:58
  Or
• 32:58
  do
• 32:58
  you
• 32:58
  d
• 32:59
  partner
• 32:59
  with
• 33:00
  an
• 33:00
  external
• 33:00
  commercial
• 33:01
  or
• 33:01
  marketing
• 33:01
  firms
• 33:02
  to
• 33:02
  lead
• 33:02
  market
• 33:03
  entry
• 33:03
  while
• 33:03
  you
• 33:04
  focus
• 33:04
  internally
• 33:05
  on
• 33:05
  product
• 33:06
  and
• 33:06
  regulatory
• 33:07
  execution.
• 33:08
  So
• 33:08
  tune
• 33:09
  in
• 33:09
  to
• 33:09
  the
• 33:09
  next
• 33:09
  episode
• 33:10
  to
• 33:10
  find
• 33:11
  out
• 33:11
  what
• 33:12
  Karen's
• 33:12
  answer
• 33:13
  is
• 33:13
  and
• 33:13
  the
• 33:13
  reason
• 33:14
  why
• 33:14
  he's
• 33:14
  picked
• 33:15
  that
• 33:15
  specific
• 33:16
  option.
• 33:16
  And
• 33:17
  if
• 33:17
  you're
• 33:17
  building
• 33:18
  a
• 33:18
  MedTech
• 33:19
  business
• 33:19
  and
• 33:20
  you're
• 33:20
  not
• 33:20
  sure
• 33:20
  whether
• 33:20
  your
• 33:21
  next
• 33:21
  move
• 33:21
  should
• 33:21
  be
• 33:21
  around
• 33:22
  evidence,
• 33:22
  market
• 33:23
  access,
• 33:23
  commercialization,
• 33:24
  distributor
• 33:25
  strategy.
• 33:25
  Or
• 33:25
  adoption.
• 33:26
  Do
• 33:27
  not
• 33:27
  guess.
• 33:28
  Book
• 33:28
  a
• 33:28
  healthcare
• 33:29
  export
• 33:29
  accelerator
• 33:30
  diagnostic
• 33:30
  Call
• 33:30
  with
• 33:31
  me.
• 33:31
  Use
• 33:31
  my
• 33:32
  link
• 33:32
  in
• 33:32
  the
• 33:32
  show
• 33:32
  notes.
• 33:33
  And
• 33:33
  in
• 33:33
  that
• 33:34
  session
• 33:34
  I'll
• 33:35
  help
• 33:35
  you
• 33:35
  identify
• 33:36
  the
• 33:36
  specific
• 33:36
  constraints
• 33:37
  blocking
• 33:38
  your
• 33:38
  momentum
• 33:39
  and
• 33:39
  the
• 33:39
  commercial
• 33:40
  move
• 33:40
  most
• 33:41
  likely
• 33:41
  to
• 33:41
  unlock
• 33:41
  your
• 33:42
  progress.
• 33:42
  Thanks
• 33:43
  for
• 33:43
  tuning
• 33:43
  in.
• 33:44
  Until
• 33:44
  next
• 33:44
  time,
• 33:45
  thanks
• 33:45
  for
• 33:45
  listening.
• 33:46
  Keep
• 33:46
  challenging
• 33:46
  your
• 33:47
  assumptions
• 33:47
  and
• 33:48
  keep
• 33:48
  growing.