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Transcript

#182 | Why Jumping To Clinical Trials Too Soon With Your Medical Device Prototype Can Be Fatal For Your Startup (For Clinicians) · 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,
• 0:01
  you're
• 0:01
  going
• 0:01
  to
• 0:01
  learn
• 0:02
  what
• 0:02
  to
• 0:02
  do
• 0:03
  after
• 0:03
  you've
• 0:03
  built
• 0:04
  a
• 0:04
  working
• 0:04
  MedTech
• 0:05
  prototype,
• 0:05
  and
• 0:06
  then
• 0:06
  you're
• 0:06
  stuck
• 0:07
  between
• 0:07
  raving
• 0:08
  funding,
• 0:09
  running
• 0:09
  clinical
• 0:09
  trials,
• 0:10
  or
• 0:10
  trying
• 0:10
  to
• 0:11
  do
• 0:11
  both.
• 0:11
  More
• 0:12
  importantly,
• 0:12
  I'm
• 0:13
  going
• 0:13
  to
• 0:13
  give
• 0:13
  you
• 0:14
  a
• 0:14
  simple
• 0:14
  decision
• 0:15
  rule
• 0:15
  that
• 0:16
  can
• 0:16
  save
• 0:16
  you
• 0:16
  months
• 0:16
  of
• 0:17
  wasted
• 0:17
  time
• 0:17
  and
• 0:17
  potentially
• 0:18
  a
• 0:18
  lot
• 0:18
  of
• 0:19
  unnecessary
• 0:19
  spend.
• 0:20
  Welcome
• 0:21
  to
• 0:21
  Clinician
• 0:21
  to
• 0:21
  CEO,
• 0:23
  the
• 0:23
  podcast
• 0:23
  helping
• 0:24
  clinicians
• 0:24
  simplify
• 0:25
  your
• 0:25
  go-to-market
• 0:26
  strategy
• 0:26
  so
• 0:27
  that
• 0:27
  you
• 0:27
  can
• 0:27
  stop
• 0:27
  guessing
• 0:28
  and
• 0:28
  turn
• 0:29
  your
• 0:29
  working
• 0:29
  prototypes
• 0:30
  into
• 0:30
  international
• 0:31
  MedTech
• 0:32
  businesses.
• 0:32
  I'm
• 0:33
  your
• 0:33
  host,
• 0:33
  Hakeem
• 0:34
  Aade.
• 0:35
  Let's
• 0:35
  get
• 0:35
  started.
• 0:36
  So
• 0:36
  in
• 0:36
  the
• 0:36
  last
• 0:37
  episode,
• 0:37
  I
• 0:37
  posed
• 0:38
  the
• 0:38
  decision
• 0:39
  scenario.
• 0:40
  You're
• 0:40
  at
• 0:40
  a
• 0:40
  critical
• 0:40
  juncture
• 0:41
  where
• 0:41
  you've
• 0:41
  developed
• 0:42
  a
• 0:42
  functional
• 0:42
  prototype
• 0:43
  of
• 0:43
  your
• 0:43
  med
• 0:44
  set
• 0:44
  device,
• 0:44
  but
• 0:45
  you're
• 0:45
  unsure
• 0:45
  about
• 0:46
  the
• 0:46
  next
• 0:46
  step.
• 0:46
  Do
• 0:47
  you
• 0:47
  a
• 0:47
  focus
• 0:48
  solely
• 0:48
  on
• 0:49
  securing
• 0:49
  funding
• 0:50
  to
• 0:50
  scale
• 0:50
  production?
• 0:51
  B?
• 0:51
  Invest
• 0:52
  time
• 0:52
  in
• 0:52
  clinical
• 0:52
  trials
• 0:53
  to
• 0:53
  validate
• 0:53
  the
• 0:53
  prototype
• 0:54
  before
• 0:54
  seeking
• 0:54
  funding.
• 0:55
  C.
• 0:56
  Split
• 0:56
  your
• 0:56
  efforts
• 0:57
  evenly
• 0:57
  between
• 0:58
  securing
• 0:59
  funding
• 0:59
  and
• 0:59
  conducting
• 1:00
  clinical
• 1:00
  trials.
• 1:01
  Or
• 1:01
  D,
• 1:02
  seek
• 1:02
  partnership
• 1:03
  with
• 1:03
  a
• 1:03
  larger
• 1:04
  institution
• 1:05
  that
• 1:05
  can
• 1:05
  provide
• 1:05
  both
• 1:06
  funding
• 1:06
  and
• 1:06
  clinical
• 1:07
  validation.
• 1:08
  Sounds
• 1:09
  like
• 1:09
  a
• 1:09
  proper
• 1:09
  strategic
• 1:10
  decision,
• 1:11
  doesn't
• 1:11
  it?
• 1:11
  And
• 1:11
  I
• 1:11
  put
• 1:11
  this
• 1:12
  exact
• 1:12
  question
• 1:12
  to
• 1:12
  Mark
• 1:13
  Fox,
• 1:13
  and
• 1:14
  his
• 1:14
  answer
• 1:15
  didn't
• 1:15
  fit
• 1:15
  any
• 1:16
  of
• 1:16
  those
• 1:16
  options.
• 1:17
  This
• 1:18
  was
• 1:18
  an
• 1:18
  interesting
• 1:19
  response.
• 1:20
  Actually,
• 1:20
  my
• 1:20
  answer
• 1:20
  wouldn't
• 1:21
  be
• 1:21
  in
• 1:21
  any
• 1:21
  of
• 1:21
  those.
• 1:22
  Instead
• 1:22
  of
• 1:22
  spending
• 1:22
  money
• 1:23
  on
• 1:23
  a
• 1:23
  bunch
• 1:23
  of
• 1:23
  mold
• 1:23
  tooling
• 1:24
  and
• 1:24
  design,
• 1:25
  I
• 1:25
  found
• 1:25
  a,
• 1:26
  company
• 1:26
  that
• 1:26
  makes
• 1:27
  Bluetooth
• 1:27
  speakers
• 1:28
  and
• 1:28
  just
• 1:28
  bought
• 1:29
  those
• 1:29
  things
• 1:29
  at
• 1:29
  $10
• 1:30
  each.
• 1:30
  I
• 1:30
  took
• 1:30
  a
• 1:31
  off
• 1:31
  the
• 1:31
  shelf
• 1:32
  product
• 1:32
  and
• 1:32
  modify
• 1:33
  it
• 1:33
  so
• 1:33
  I
• 1:33
  could
• 1:33
  actually
• 1:33
  test
• 1:34
  it
• 1:34
  with
• 1:34
  friends
• 1:35
  and
• 1:35
  family
• 1:35
  and
• 1:35
  other
• 1:35
  people
• 1:36
  to
• 1:36
  not
• 1:37
  see
• 1:37
  if
• 1:37
  the
• 1:37
  function
• 1:38
  of
• 1:38
  the
• 1:38
  device
• 1:39
  worked.
• 1:39
  I
• 1:40
  wanted
• 1:40
  to
• 1:40
  see
• 1:40
  if
• 1:40
  the
• 1:40
  therapeutic
• 1:41
  results
• 1:42
  were
• 1:42
  there.
• 1:42
  There's
• 1:43
  no
• 1:43
  sense
• 1:43
  in
• 1:43
  making
• 1:43
  a,
• 1:44
  super
• 1:44
  fancy
• 1:45
  designed
• 1:46
  device
• 1:47
  if
• 1:47
  the
• 1:47
  actual.
• 1:48
  Therapy
• 1:49
  didn't
• 1:49
  work.
• 1:49
  I
• 1:49
  looked
• 1:50
  around
• 1:50
  and
• 1:50
  said,
• 1:50
  how
• 1:50
  can
• 1:51
  I
• 1:51
  hack
• 1:51
  what
• 1:51
  exists,
• 1:53
  And
• 1:53
  that
• 1:53
  right
• 1:54
  there
• 1:54
  in
• 1:55
  Mark's
• 1:55
  answer
• 1:55
  is
• 1:55
  where
• 1:56
  most
• 1:56
  Med
• 1:56
  Tech
• 1:57
  founders
• 1:57
  go
• 1:57
  wrong.
• 1:58
  Because
• 1:58
  most
• 1:58
  people
• 1:59
  in
• 1:59
  that
• 1:59
  situation,
• 1:59
  they
• 2:00
  go
• 2:00
  straight
• 2:00
  for
• 2:00
  funding
• 2:01
  or
• 2:01
  straight
• 2:02
  for
• 2:02
  clinical
• 2:02
  trials.
• 2:03
  They
• 2:03
  pick
• 2:03
  one
• 2:03
  of
• 2:03
  the
• 2:03
  two.
• 2:04
  But
• 2:04
  what
• 2:04
  Mark
• 2:05
  just
• 2:05
  did
• 2:05
  is
• 2:05
  completely
• 2:06
  different.
• 2:06
  He
• 2:07
  didn't
• 2:07
  test
• 2:07
  the
• 2:07
  product.
• 2:08
  He
• 2:08
  tested
• 2:09
  the
• 2:09
  assumption,
• 2:10
  and
• 2:10
  this
• 2:10
  is
• 2:10
  the
• 2:10
  bit
• 2:11
  you
• 2:11
  need
• 2:11
  to
• 2:11
  really
• 2:12
  get
• 2:12
  your
• 2:12
  head
• 2:12
  around.
• 2:13
  Most
• 2:13
  founders
• 2:14
  think
• 2:14
  progress
• 2:15
  looks
• 2:15
  like.
• 2:15
  Either
• 2:16
  building
• 2:16
  more
• 2:16
  or
• 2:17
  raising
• 2:17
  money,
• 2:18
  raving
• 2:18
  more
• 2:18
  money,
• 2:19
  or
• 2:19
  moving
• 2:19
  into
• 2:20
  trials.
• 2:20
  But
• 2:20
  none
• 2:21
  of
• 2:21
  that
• 2:21
  matters
• 2:22
  if
• 2:22
  the
• 2:22
  core
• 2:22
  thing
• 2:23
  doesn't
• 2:23
  work
• 2:23
  in
• 2:24
  the
• 2:24
  real
• 2:24
  world.
• 2:25
  Not
• 2:25
  in
• 2:25
  theory,
• 2:26
  not
• 2:26
  in
• 2:26
  a
• 2:26
  controlled
• 2:27
  environment,
• 2:27
  not
• 2:27
  in
• 2:27
  your
• 2:28
  own
• 2:28
  head,
• 2:28
  but
• 2:29
  in
• 2:29
  reality.
• 2:30
  So
• 2:30
  here's
• 2:31
  the
• 2:31
  decision
• 2:31
  rule
• 2:32
  that
• 2:32
  I
• 2:32
  want
• 2:32
  you
• 2:32
  to
• 2:32
  take
• 2:33
  away
• 2:33
  from
• 2:33
  this,
• 2:34
  and
• 2:34
  the
• 2:34
  rule
• 2:34
  is
• 2:34
  called.
• 2:35
  Unfortunately
• 2:35
  not
• 2:35
  that
• 2:36
  inevitably
• 2:36
  the
• 2:36
  hack
• 2:37
  it
• 2:37
  before
• 2:38
  you
• 2:38
  build
• 2:38
  it
• 2:38
  rule.
• 2:39
  So
• 2:40
  before
• 2:40
  you
• 2:40
  commit
• 2:41
  to
• 2:41
  funding
• 2:42
  or
• 2:42
  go
• 2:42
  into
• 2:42
  trials,
• 2:43
  go
• 2:43
  through
• 2:43
  these
• 2:44
  four
• 2:45
  steps.
• 2:45
  Number
• 2:46
  one,
• 2:46
  define
• 2:47
  the
• 2:48
  core
• 2:48
  assumption.
• 2:49
  What
• 2:49
  is
• 2:49
  the
• 2:49
  one
• 2:50
  thing
• 2:50
  that
• 2:50
  must
• 2:50
  be
• 2:51
  true?
• 2:51
  Not
• 2:51
  the
• 2:51
  product
• 2:52
  but
• 2:52
  the
• 2:52
  outcome.
• 2:54
  A,
• 2:54
  does
• 2:54
  the
• 2:54
  therapy
• 2:55
  actually
• 2:55
  deliver
• 2:56
  results?
• 2:56
  Does
• 2:57
  it
• 2:57
  create
• 2:57
  meaningful
• 2:58
  change?
• 2:59
  If
• 2:59
  this
• 2:59
  isn't
• 2:59
  proven.
• 3:00
  Then
• 3:00
  everything
• 3:01
  else
• 3:01
  is
• 3:01
  guesswork.
• 3:02
  And
• 3:02
  then
• 3:03
  number
• 3:03
  two,
• 3:03
  find
• 3:04
  the
• 3:04
  fastest
• 3:05
  way
• 3:05
  to
• 3:05
  test
• 3:05
  it.
• 3:06
  Not
• 3:06
  the
• 3:06
  cleanest
• 3:06
  way,
• 3:07
  not
• 3:07
  the
• 3:07
  most
• 3:07
  impressive
• 3:08
  way,
• 3:08
  but
• 3:09
  the
• 3:09
  fastest,
• 3:10
  mark
• 3:10
  didn't
• 3:10
  build
• 3:11
  a
• 3:11
  product
• 3:11
  from
• 3:11
  scratch.
• 3:12
  He
• 3:12
  found
• 3:12
  something
• 3:12
  that
• 3:13
  existed
• 3:13
  and
• 3:14
  he
• 3:14
  modified
• 3:14
  it,
• 3:15
  and
• 3:15
  that
• 3:15
  gives
• 3:15
  you
• 3:15
  speed,
• 3:16
  and
• 3:16
  speed
• 3:17
  gives
• 3:17
  you
• 3:17
  advantage.
• 3:17
  Number
• 3:18
  three,
• 3:19
  ignore
• 3:19
  everything
• 3:20
  else
• 3:20
  for
• 3:20
  now.
• 3:21
  This
• 3:21
  is
• 3:21
  where
• 3:22
  people
• 3:22
  really
• 3:23
  tend
• 3:23
  to
• 3:23
  struggle
• 3:24
  because
• 3:24
  it
• 3:24
  feels
• 3:25
  uncomfortable,
• 3:26
  but
• 3:26
  you
• 3:26
  have
• 3:26
  to
• 3:26
  ignore
• 3:27
  the
• 3:27
  design.
• 3:28
  You
• 3:28
  have
• 3:28
  to
• 3:28
  ignore
• 3:29
  scalability.
• 3:30
  You
• 3:30
  have
• 3:30
  to
• 3:30
  ignore
• 3:31
  manufacturing.
• 3:32
  Even
• 3:32
  parts
• 3:33
  of
• 3:33
  regulation
• 3:34
  you
• 3:34
  have
• 3:34
  to
• 3:34
  ignore
• 3:34
  early
• 3:34
  on
• 3:35
  because
• 3:35
  if
• 3:35
  the
• 3:35
  core
• 3:35
  assumption
• 3:36
  fails,
• 3:37
  then
• 3:37
  everything
• 3:37
  that
• 3:37
  you've
• 3:37
  done
• 3:38
  and
• 3:38
  everything
• 3:38
  that
• 3:38
  you
• 3:38
  do
• 3:39
  is
• 3:39
  gonna
• 3:39
  be
• 3:39
  completely
• 3:40
  and
• 3:40
  utterly
• 3:41
  wasted
• 3:41
  effort.
• 3:42
  Then
• 3:43
  we
• 3:43
  move
• 3:43
  on
• 3:43
  to
• 3:43
  the
• 3:44
  fourth
• 3:44
  and
• 3:44
  final
• 3:44
  one.
• 3:45
  Once
• 3:45
  you've
• 3:45
  defined
• 3:46
  the
• 3:46
  core
• 3:46
  assumption,
• 3:47
  once
• 3:47
  you've
• 3:47
  found
• 3:48
  the
• 3:48
  fastest
• 3:48
  way
• 3:48
  to
• 3:48
  test
• 3:49
  it,
• 3:49
  and
• 3:49
  then
• 3:49
  once
• 3:50
  you've
• 3:50
  done
• 3:50
  that
• 3:50
  with
• 3:50
  a
• 3:50
  singular
• 3:51
  focus
• 3:52
  and
• 3:52
  you've
• 3:52
  ignored
• 3:53
  everything
• 3:53
  else,
• 3:54
  you
• 3:54
  move
• 3:54
  on
• 3:55
  to
• 3:55
  number
• 3:55
  four.
• 3:56
  You
• 3:56
  choose
• 3:57
  your
• 3:57
  path.
• 3:58
  Once
• 3:58
  you
• 3:58
  know
• 3:58
  that
• 3:59
  it
• 3:59
  works,
• 3:59
  you
• 4:00
  raise
• 4:00
  the
• 4:00
  funding,
• 4:01
  you
• 4:01
  then
• 4:01
  run
• 4:02
  the
• 4:02
  clinical
• 4:02
  trials,
• 4:03
  you
• 4:03
  then
• 4:03
  scale.
• 4:04
  Now
• 4:05
  you
• 4:05
  are
• 4:05
  actually
• 4:05
  building
• 4:06
  something
• 4:06
  that's
• 4:07
  real.
• 4:07
  Let
• 4:07
  me
• 4:07
  be
• 4:07
  blunt,
• 4:08
  and
• 4:08
  I'm
• 4:08
  sure
• 4:08
  that
• 4:09
  you're
• 4:09
  not
• 4:09
  one
• 4:09
  of
• 4:09
  these,
• 4:10
  but
• 4:10
  a
• 4:10
  lot
• 4:10
  of
• 4:11
  founders
• 4:11
  hide
• 4:12
  behind
• 4:12
  complexity
• 4:13
  because
• 4:14
  raising
• 4:15
  funding
• 4:16
  feels
• 4:16
  productive.
• 4:17
  That's
• 4:17
  fair
• 4:17
  enough.
• 4:18
  Preparing
• 4:18
  for
• 4:19
  trials
• 4:19
  feels
• 4:20
  credible.
• 4:20
  Building
• 4:21
  features
• 4:22
  feels
• 4:22
  like
• 4:22
  you're
• 4:22
  progressing,
• 4:23
  but
• 4:23
  sometimes
• 4:24
  it's
• 4:25
  just
• 4:25
  expensive
• 4:26
  procrastination.
• 4:27
  And
• 4:27
  Mark
• 4:28
  didn't
• 4:28
  do
• 4:28
  that.
• 4:28
  What
• 4:29
  did
• 4:29
  he
• 4:29
  do?
• 4:29
  He
• 4:29
  got
• 4:29
  very
• 4:30
  scrappy.
• 4:30
  He
• 4:31
  tested
• 4:31
  the
• 4:31
  thing
• 4:32
  that
• 4:32
  actually
• 4:32
  mattered,
• 4:33
  and
• 4:33
  he
• 4:33
  got.
• 4:34
  Answers
• 4:34
  fast.
• 4:35
  So
• 4:36
  next
• 4:36
  time
• 4:36
  you're
• 4:36
  faced
• 4:37
  with
• 4:37
  a
• 4:37
  big
• 4:37
  decision,
• 4:38
  don't
• 4:38
  just
• 4:39
  pick
• 4:39
  from
• 4:39
  the
• 4:39
  options
• 4:40
  right
• 4:40
  in
• 4:40
  front
• 4:40
  of
• 4:40
  you.
• 4:41
  Challenge
• 4:41
  the
• 4:41
  question
• 4:42
  because
• 4:42
  the
• 4:42
  smartest
• 4:43
  move
• 4:43
  might
• 4:44
  not
• 4:44
  be
• 4:44
  option
• 4:45
  A,
• 4:45
  option
• 4:45
  B,
• 4:46
  option
• 4:46
  C,
• 4:46
  or
• 4:46
  option
• 4:47
  D.
• 4:47
  It
• 4:47
  might
• 4:48
  just
• 4:48
  be
• 4:49
  to
• 4:49
  find
• 4:49
  a
• 4:49
  way
• 4:49
  to
• 4:50
  test
• 4:50
  the
• 4:50
  core
• 4:50
  assumption
• 4:51
  quickly,
• 4:52
  cheaply,
• 4:52
  and
• 4:53
  in
• 4:53
  the
• 4:53
  real
• 4:54
  world.
• 4:55
  And
• 4:55
  if
• 4:55
  you're
• 4:55
  building
• 4:56
  a
• 4:56
  MedTech
• 4:56
  business
• 4:57
  and
• 4:57
  you're
• 4:57
  not
• 4:58
  sure
• 4:58
  whether
• 4:59
  your
• 4:59
  next
• 4:59
  move
• 4:59
  should
• 5:00
  be
• 5:00
  around
• 5:00
  evidence,
• 5:01
  market
• 5:01
  access,
• 5:02
  commercialization,
• 5:03
  distributor
• 5:04
  strategy,
• 5:04
  or
• 5:04
  adoption.
• 5:05
  Don't
• 5:05
  guess.
• 5:06
  Booker
• 5:07
  Healthcare
• 5:07
  export
• 5:08
  accelerated
• 5:08
  diagnostic
• 5:09
  Call
• 5:09
  with
• 5:09
  me.
• 5:10
  Use
• 5:10
  the
• 5:10
  link
• 5:11
  in
• 5:11
  the
• 5:11
  show
• 5:11
  notes
• 5:12
  and
• 5:12
  in
• 5:12
  that
• 5:12
  session
• 5:13
  I'll
• 5:13
  help
• 5:13
  you
• 5:13
  identify
• 5:14
  the
• 5:14
  specific
• 5:14
  constraints
• 5:15
  blocking
• 5:16
  your
• 5:16
  momentum
• 5:16
  and
• 5:16
  the
• 5:17
  commercial
• 5:17
  move,
• 5:18
  most
• 5:18
  likely
• 5:18
  to
• 5:19
  unlock
• 5:19
  your
• 5:19
  progress.
• 5:20
  Until
• 5:20
  next
• 5:21
  time.
• 5:21
  Thanks
• 5:21
  for
• 5:21
  listening.
• 5:22
  Keep
• 5:22
  challenging
• 5:23
  your
• 5:23
  assumptions
• 5:24
  and
• 5:24
  keep
• 5:25
  growing.