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From Idea to Market: Ep 3 - Proof of Concept · AHF Podcast

0:22
Joseph M. Schwab: Hello and welcome to the AHF Podcast.
0:25
Joseph M. Schwab: I'm your host, Joe Schwab.
0:27
Joseph M. Schwab: From Idea to Market is a series about how medical innovation actually happens, not as a straight line from idea to product, but as a sequence of moments where innovators test assumptions, confront reality and decide whether to keep going.
0:45
Joseph M. Schwab: If you're just joining us, I highly recommend going back to episodes one and two.
0:51
Joseph M. Schwab: In those chapters, we explored the spark.
0:54
Joseph M. Schwab: That moment when a problem becomes an obligation and the shaping where we determined if the juice was worth the squeeze.
1:02
Joseph M. Schwab: But once you've decided an idea is worth your time and your capital, you hit a bit of a wall.
1:09
Joseph M. Schwab: That wall is reality.
1:12
Joseph M. Schwab: Up until now, your project has lived in the safety of conversation.
1:17
Joseph M. Schwab: Today we move it into The Crucible.
1:20
Joseph M. Schwab: This is the stage where ideas are forced to function.
1:40
Joseph M. Schwab: You're going to hear many different voices in this episode, and those voices represent people who have seen innovation unfold.
1:49
Joseph M. Schwab: From the inside, rather than introducing them one by one, we want you to first meet them in their own words
1:58
Jared Foran: I'm Jared Foran.
1:59
Jared Foran: I'm an orthopedic surgeon in Denver, Colorado.
2:01
Jared Foran: I'm a hip and knee arthroplasty specialist.
2:04
Jared Foran: I'm the Chief Scientific Officer of Forcast Orthopedics, and I'm one of the co-founders.
2:10
Leo Whiteside: Oh, I'm Leo Whiteside.
2:11
Leo Whiteside: I'm an orthopedic surgeon.
2:13
Leo Whiteside: Just, uh, retired last January.
2:16
Leo Whiteside: Uh, engaged in hip and knee replacement, uh, sort of subspecializing and.
2:22
Leo Whiteside: Uh, infected arthroplasty.
2:24
Peter Noymer: Hi, my name is Peter Noymer.
2:26
Peter Noymer: I'm the CEO of ForCast Orthopedics.
2:28
Peter Noymer: I'm also a PhD in mechanical engineering.
2:30
Peter Noymer: I've spent nearly 30 years, uh, working on, uh, developing novel drug delivery systems for improving treatments across a number of different therapeutic areas.
2:40
Marie-Isabelle Batthyány: My name is Marie-Isabelle Batthyány I'm an board certified anesthesiologist specializing in orthopedic anesthesia at the orthopedic hospital Speising in Vienna.
2:53
Marie-Isabelle Batthyány: And I'm also the founder and CEO of XR Synergies, which is an Austrian company where we build vr, virtual reality patient education tools designed for maximum legal, security and efficiency for our fellow doctor colleagues.
3:09
Doug Fairbanks: my name is Doug Fairbanks.
3:11
Doug Fairbanks: I'm the president, CEO, and board member at VISIE Inc.
3:14
Simon Mifsud: Hello, my name is Simon Mifsud and I'm a co-founder and the CEO of Garland Surgical Limited based in the UK.
3:22
Simon Mifsud: And we're developing a novel hip replacement system called the Malta Hip.
3:26
Robert Cohen: My name is Robert Cohen and I am a mechanical engineer that have worked in the med tech industry for over four decades, and I presently am the Vice President of innovation and technology for the Orthopedic Group at Stryker.
3:40
Joseph M. Schwab: Together their stories help us understand what proof of concept really looks like in real life.
3:48
Joseph M. Schwab: In this episode, we focus on three questions that define proof of concept.
3:54
Joseph M. Schwab: First, what must be proven before an idea earns credibility.
4:00
Joseph M. Schwab: Second, which assumptions survive, first contact with reality and which don't.
4:06
Joseph M. Schwab: And third, how much uncertainty can exist before progress begins to stall?
4:14
Joseph M. Schwab: This is where innovation meets physics, biology, workflow, and human behavior, and where ideas are required to hold up under real conditions.
4:26
Joseph M. Schwab: This is chapter three, proof of Concept.
4:35
Joseph M. Schwab: A good idea can survive a meeting.
4:38
Joseph M. Schwab: It can survive a slide deck and it can even survive a strong opinion, but it can't survive real world constraints unless it's been tested against them.
4:50
Joseph M. Schwab: Up to this point in the series, ideas have been shaped through observation and discussion and instinct.
4:56
Joseph M. Schwab: When people picture proof of concept, they often picture a prototype.
5:01
Joseph M. Schwab: But in medical devices, proof of concept actually starts earlier than that because in a regulated environment, you don't get credibility by building something, you get credibility by proving you can build the right thing.
5:18
Joseph M. Schwab: And that means a shift from excitement to discipline.
5:24
Joseph M. Schwab: You need requirements, you need a plan, and you need a clear definition of what success would even mean.
5:33
Joseph M. Schwab: So let's start there.
5:35
Joseph M. Schwab: What must be proven before an idea earns credibility?
5:44
Joseph M. Schwab: In this series, we've talked about how ideas begin and how they get shaped, but proof of concept is the first time the idea has to become accountable.
5:52
Joseph M. Schwab: And in med tech accountability usually starts with a simple question.
5:57
Joseph M. Schwab: What exactly are we claiming this thing will do?
6:03
Joseph M. Schwab: It sounds obvious, but it's often where teams get stuck because early ideas are usually broad.
6:10
Joseph M. Schwab: They're flexible, they're full of what if a project plan forces the opposite?
6:17
Joseph M. Schwab: Now, a project plan doesn't guarantee clarity.
6:21
Joseph M. Schwab: It forces the team to write things down.
6:25
Joseph M. Schwab: It forces specificity around questions like, what is the intended use and who is the intended user?
6:35
Joseph M. Schwab: What environment are they likely to be using it in, and what are the constraints, if any.
6:42
Joseph M. Schwab: Are there risks, and if so, are they acceptable?
6:46
Joseph M. Schwab: And what evidence would we need to show that our design is controlled?
6:51
Joseph M. Schwab: Repeatable in standard medical device development.
6:55
Joseph M. Schwab: This isn't just a management preference, it's a part of how regulators expect teams to operate.
7:03
Joseph M. Schwab: FDA design controls, for example, are built around the idea that you define design inputs, produce design outputs, and then generate objective evidence through verification and validation.
7:17
Joseph M. Schwab: You met those requirements and the documentation trail often captured through what's called a design history file exists because the process matters, not just the end result.
7:31
Joseph M. Schwab: That's why the plan isn't separate from the innovation.
7:35
Joseph M. Schwab: It's the mechanism that turns an idea into something testable.
7:42
Joseph M. Schwab: And it's the first filter against a common failure mode.
7:45
Joseph M. Schwab: At this stage, teams keep adding features.
7:50
Joseph M. Schwab: The scope expands, the requirements become fuzzy, and the prototype becomes expensive before anyone can prove the core portion works.
8:03
Joseph M. Schwab: Proof of concept is supposed to do the opposite.
8:06
Joseph M. Schwab: It's supposed to narrow the claim to something that can be tested, and it's supposed to get the team confident enough on paper to spend money on a prototype.
8:17
Joseph M. Schwab: Knowing that the first prototype isn't the finish line, it's a learning tool.
8:23
Joseph M. Schwab: It will expose risks, it'll expose constraints, and it'll reveal the gap between what looked good in theory and what works in practice.
8:36
Joseph M. Schwab: Doug Fairbanks describes what it looks like when a team commits to that discipline.
8:42
Doug Fairbanks: And so it was a time where I realized, Hey, look, if you want something done, jump in.
8:47
Doug Fairbanks: Apply yourself.
8:48
Doug Fairbanks: Set very aggressive goals.
8:50
Doug Fairbanks: And don't worry about the obstacles.
8:52
Joseph M. Schwab: What Doug is describing isn't motivation.
8:55
Joseph M. Schwab: It's a decision to define the target and then prove it.
8:58
Joseph M. Schwab: And in his case, proof wasn't vague.
9:01
Joseph M. Schwab: It was measurable.
9:03
Doug Fairbanks: And so when I came across Advanced Scanners, we said, okay, it's taking pictures of the patient and how do we get it to see the patient in real time?
9:12
Doug Fairbanks: And the team got latched onto that and they wouldn't let it go.
9:16
Doug Fairbanks: They just said, we're gonna deliver that, we're gonna deliver that.
9:19
Doug Fairbanks: And the first time they did it kind of fast was four times a second.
9:23
Doug Fairbanks: It's unbelievably still how four times the second is.
9:27
Doug Fairbanks: But then they said, well, we can go faster.
9:28
Doug Fairbanks: We can go faster.
9:29
Doug Fairbanks: And before you know it, that the question of speed was no longer a thing.
9:34
Doug Fairbanks: And we can see the patient and we can remove all this hassle to the procedure and we can really consider what is the impact on the surgeon and what is the impact on the patient and how do you deliver something better.
9:45
Doug Fairbanks: And so we're excited about what CAAT has done.
9:47
Joseph M. Schwab: This is the core of our first question.
9:51
Joseph M. Schwab: Proof of concept earns credibility when it demonstrates objective performance against defined requirements, not, we think it helps, not it looks promising.
10:03
Joseph M. Schwab: But here is what we claimed, and here's the evidence that it meets that claim.
10:09
Joseph M. Schwab: This is also why proof of concept is a gate for outside stakeholders.
10:14
Joseph M. Schwab: Robert Cohen explains how larger organizations often interpret proof of concept.
10:20
Robert Cohen: So I think in one sense of it, I was a small company guy with Mako, but helping them get the technology and proof of concept and in the Stryker, Stryker expects to see that proof of concept de-risked.
10:32
Robert Cohen: But is it something that could be expanded and grow to drive revenue?
10:37
Robert Cohen: Prove the technology.
10:39
Robert Cohen: Prove that it's ready to be marketed and get through all the burdens.
10:43
Joseph M. Schwab: So here's our first answer.
10:45
Joseph M. Schwab: A concept earns credibility when the team can define what must be true and produce early evidence that it is true under real constraints.
10:56
Joseph M. Schwab: That's what the project plan and requirements work is really doing for you.
11:02
Joseph M. Schwab: It's not slowing the idea down, it's making your idea testable, but proof of concept does something else.
11:11
Joseph M. Schwab: At the same time.
11:12
Joseph M. Schwab: It doesn't just validate what works.
11:15
Joseph M. Schwab: It reveals what breaks.
11:18
Joseph M. Schwab: Because the first time an idea touches the real world, it runs into systems, inventory, workflow, economics, and human behavior.
11:28
Joseph M. Schwab: Which brings us to question two.
11:31
Joseph M. Schwab: Which assumptions survive first contact with reality and which don't?
11:41
Joseph M. Schwab: This is the part of innovation that tends to surprise people.
11:45
Joseph M. Schwab: A design can function, the engineering can be correct, and the idea can still fail because healthcare is not only a clinical environment, it's an operating environment.
11:59
Joseph M. Schwab: Hospitals have procurement processes.
12:03
Joseph M. Schwab: They have shelf space constraints, they have bundled payments, they have training burdens, they have committees, they have risk tolerance, so.
12:12
Joseph M. Schwab: Proof of concept is often where teams learn that the hardest problems aren't technical, they're system problems.
12:20
Joseph M. Schwab: Jared Foran described how early concepts can seem viable at first until reality starts to push back.
12:29
Jared Foran: The initial idea was to have an antibiotic eluding polyethylene spacer we, we engineered it, it worked.
12:35
Jared Foran: The problem with it, you can imagine you'd have to have an incredible number of polyethylene sizes on the shelf at every hospital just waiting for the infected patient, which is economically not practical.
12:47
Joseph M. Schwab: The idea functioned the system didn't.
12:51
Joseph M. Schwab: So economic feasibility, inventory, complexity and hospital logistics introduced constraints that engineering alone couldn't solve.
13:00
Joseph M. Schwab: And this pattern shows up again and again in healthcare innovation.
13:05
Joseph M. Schwab: Studies of technology adoption consistently find that many solutions fail, not because they don't work, but because they clash with workflow.
13:16
Joseph M. Schwab: Or reimbursement models or supply chains, or time pressures that clinicians face every day.
13:23
Joseph M. Schwab: Proof of concept is often where teams discover that the hardest problems aren't technical at all.
13:30
Joseph M. Schwab: So the team iterates.
13:33
Jared Foran: And then we shifted to this magnetically coupled subcutaneous pump.
13:38
Jared Foran: We got the engineering there.
13:39
Jared Foran: It was gonna deliver antibiotics.
13:41
Jared Foran: The problem is surgeons didn't wanna go back and have to take something out.
13:45
Joseph M. Schwab: Again, solved one problem, uncovered another.
13:50
Joseph M. Schwab: That back and forth is normal at proof of concept.
13:54
Joseph M. Schwab: It's why the phase is often called a risk reduction phase in standard development playbooks.
14:01
Joseph M. Schwab: The point is to find the failure modes early.
14:04
Joseph M. Schwab: When changes are still possible, and when teams do survive this stage, they tend to converge on the same three conditions that Jared describes.
14:15
Joseph M. Schwab: Clinical value, usability, and economic viability.
14:21
Jared Foran: I learned that you need essentially three things.
14:24
Jared Foran: You need a good idea and it has to be very usable for the surgeon.
14:29
Jared Foran: Very usable for the patient.
14:30
Jared Foran: And it has to be able to make money.
14:32
Jared Foran: And so you kinda learn that the hard way.
14:35
Joseph M. Schwab: So here's our second answer.
14:37
Joseph M. Schwab: The assumptions that survive are the ones that hold up across the full operating reality, not just the engineering.
14:46
Joseph M. Schwab: Early development stages exist specifically to test assumptions and expose weaknesses before larger investments are made Iteration here.
14:55
Joseph M. Schwab: It doesn't represent a setback.
14:58
Joseph M. Schwab: It's how risk is reduced before it reaches patients and systems.
15:04
Joseph M. Schwab: Leo Whiteside describes a similar learning curve moving away from what seemed workable toward what could actually survive real conditions.
15:14
Leo Whiteside: A fellow named Clayton Perry back then was working with a fusion pump that I had all sorts of trouble with a pump.
15:22
Leo Whiteside: And, and I ran across the Hickman catheter and it has a cuff around the tube that seals the cuff so you don't get leakage.
15:32
Leo Whiteside: That, that was the only reasonable way that I could find to, to do prolonged injections.
15:38
Joseph M. Schwab: This is what proof of concept does.
15:41
Joseph M. Schwab: It pushes teams away from what's sophisticated and towards what's workable.
15:45
Joseph M. Schwab: And once you see which assumptions don't survive, you're left with a new question.
15:51
Joseph M. Schwab: How much uncertainty is still acceptable before you move forward?
15:56
Joseph M. Schwab: At the end of this phase, uncertainty doesn't disappear, but it does change shape.
16:02
Joseph M. Schwab: It becomes specific, and teams have to decide whether the remaining unknowns are manageable or whether progress is truly starting to stall.
16:13
Joseph M. Schwab: Which brings us to question three, how much uncertainty can exist before progress begins to stall?
16:26
Joseph M. Schwab: A common misunderstanding about proof of concept is that it creates certainty.
16:31
Joseph M. Schwab: It doesn't.
16:33
Joseph M. Schwab: What it does is shrink uncertainty.
16:37
Joseph M. Schwab: To a size that the team can responsibly carry in innovation research, this is often described as crossing a gap between early proof and real world translation, which many people call the Valley of Death.
16:54
Joseph M. Schwab: The point is not to eliminate every unknown.
16:57
Joseph M. Schwab: The point is to reduce the unknowns that would make the next investment irresponsible.
17:03
Joseph M. Schwab: So you can think of this phase as building an uncertainty budget.
17:09
Joseph M. Schwab: What is still unknown?
17:11
Joseph M. Schwab: Can we test it?
17:12
Joseph M. Schwab: Can we measure it?
17:13
Joseph M. Schwab: And do we understand the risk well enough to keep moving?
17:19
Joseph M. Schwab: Peter Noymer describes how doing the work market research literature and the numbers changed his assumptions about feasibility.
17:29
Peter Noymer: But as I plugged through the numbers that are out there, I did a little bit of market research.
17:33
Peter Noymer: I dove through the literature.
17:35
Peter Noymer: And came up with the, oh, you know, you can actually get a product to market for probably, less money than I thought, and the return on investment especially the revenue potential was much, much stronger than I thought.
17:47
Joseph M. Schwab: This kind of analysis is common as proof of concept.
17:51
Joseph M. Schwab: Technical uncertainty begins to translate into business and clinical risk, market size, adoption potential and economic viability become part of the feasibility question, not something saved for later evidence from healthcare.
18:06
Joseph M. Schwab: Venture and innovation studies show that early alignment.
18:10
Joseph M. Schwab: Between clinical value and economic reality is one of the strongest predictors of whether a concept advances beyond this stage.
18:20
Joseph M. Schwab: Marie Isabelle Beyani describes the same thing through iteration, realizing quickly what wasn't scalable, and switching approaches.
18:31
Marie-Isabelle Batthyány: The first prototype really was real VR films, and it just turned out very quickly that that was not a scalable solution at all because we had.
18:42
Marie-Isabelle Batthyány: You made one mistake or had one content adaptation and you had to get the whole filming team together to redo it all again.
18:50
Marie-Isabelle Batthyány: So very quickly switched from prototyping to, um, meta humans where we could, uh, change content more easily and also adapt, uh, mimic and body language.
19:04
Marie-Isabelle Batthyány: And gender and all this much easier.
19:08
Joseph M. Schwab: That's proof of concept doing its job.
19:11
Joseph M. Schwab: It tells you what path is viable, and sometimes instead of a series of small iterations, one test creates a real shift for Simon msu.
19:24
Joseph M. Schwab: That moment happened when the concept entered the cadaver lab.
19:29
Simon Mifsud: There were probably two moments, uh, to be fair, that made us realize that the concept was.
19:36
Simon Mifsud: Viable behind theory.
19:38
Simon Mifsud: Um, in June of 2019, we did our first cadaveric um, surgery at the University of Malta, and two Maltese surgeons tested, uh, and implanted the device using a standard, um, approach, and they were able to demonstrate the resistance to dislocation of the implant.
19:57
Simon Mifsud: And in fact, that's when the, um.
20:00
Simon Mifsud: When the idea came about that this device would allow a patient to get into, uh, the deep squat in yoga, which is known as the malasana pose, but is also known as the garland pose, and that's where we drew our name from.
20:15
Joseph M. Schwab: So proof of concept doesn't remove risk, but it changes the conversation from, is this plausible to what would it take to make this real?
20:27
Joseph M. Schwab: And by the end of this stage, something important has happened.
20:31
Joseph M. Schwab: The idea is no longer hypothetical.
20:36
Joseph M. Schwab: Some assumptions held.
20:38
Joseph M. Schwab: Some broke and the gap between what was imagined and what actually works is now visible at this stage, teams aren't looking for certainty.
20:51
Joseph M. Schwab: They're looking for movement.
20:54
Joseph M. Schwab: So here's our third answer.
20:56
Joseph M. Schwab: Progress stalls when uncertainty stops shrinking when the next experiment can't be defined, when risks are still unknown.
21:06
Joseph M. Schwab: Not just unresolved or when the remaining uncertainty is larger than the team can responsibly carry forward.
21:22
Joseph M. Schwab: So let's take a step back and answer the three questions we set out to explore First, what must be proven before an idea earns credibility?
21:31
Joseph M. Schwab: Well, a concept earns credibility when it produces evidence against defined requirements.
21:38
Joseph M. Schwab: Not just a prototype, but proof that the claim holds under real constraints.
21:44
Joseph M. Schwab: That's why project plans and requirements matter.
21:48
Joseph M. Schwab: They make proof measurable, and they make early investment rational.
21:54
Joseph M. Schwab: Second, which assumptions survive first contact with reality?
22:00
Joseph M. Schwab: Well, the ones that hold up not only in engineering, but in systems, logistics, workflow and economics.
22:09
Joseph M. Schwab: Jared's story is a reminder that the device can work and still fail if it doesn't fit the environment expected to adopt it.
22:19
Joseph M. Schwab: Third, how much uncertainty can exist before a progress stalls?
22:25
Joseph M. Schwab: Well, not zero, but uncertainty has to shrink.
22:31
Joseph M. Schwab: The unknowns need to become testable and measurable and understood when uncertainty stops moving.
22:40
Joseph M. Schwab: The project stops moving.
22:43
Joseph M. Schwab: So proof of concept is not about being finished, it's about being honest, honest about what works, and honest about what doesn't, and honest about whether this idea deserves the next chapter.
23:06
Joseph M. Schwab: If there's one takeaway from this episode, it's this proof of concept is where ideas earn the right to continue.
23:15
Joseph M. Schwab: Not because the team feels confident, but because the evidence is getting stronger and the risks are getting more clear.
23:23
Joseph M. Schwab: If you're listening and you're holding an idea right now, this stage can feel slow.
23:32
Joseph M. Schwab: But this work is what protects you later.
23:36
Joseph M. Schwab: It protects you from building the wrong thing.
23:39
Joseph M. Schwab: It protects you from spending too much too early.
23:44
Joseph M. Schwab: It protects your future users by forcing the hard questions upfront.
23:51
Joseph M. Schwab: Because the goal isn't just to make something that works.
23:55
Joseph M. Schwab: It's to make something that can survive reality and eventually reach patients.
24:02
Joseph M. Schwab: In our next episode, we follow what happens when the proof is strong enough to move forward, because once an idea survives proof of concept, the work changes.
24:13
Joseph M. Schwab: It becomes operational.
24:16
Joseph M. Schwab: It becomes organizational, and the question becomes not can this work, but can this become a company?