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From Idea to Market: Ep 7 - Beyond Clearance · AHF Podcast

0:21
Joseph M. Schwab: Hello and welcome to the AHF Podcast.
0:24
Joseph M. Schwab: I'm your host, Joe Schwab.
0:26
Joseph M. Schwab: From Idea to Market is a series about how medical innovation actually happens, not as a straight line from insight to impact, but as a sequence of tests that determine whether an idea can survive the real world.
0:42
Joseph M. Schwab: If you're just joining us, I highly recommend pausing and going back to the beginning of the series, the six episodes before this one form the foundation for everything we're about to discuss.
0:54
Joseph M. Schwab: We started with the spark.
0:56
Joseph M. Schwab: That moment when a problem in daily clinical practice becomes an obligation to fix, we shaped the idea.
1:04
Joseph M. Schwab: Stress tested it against reality.
1:07
Joseph M. Schwab: In proof of concept, chose the right structure to carry it forward, navigated the capital markets, and in the latest episode, we crossed the regulatory threshold.
1:19
Joseph M. Schwab: Years of evidence, expense, and uncertainty.
1:23
Joseph M. Schwab: Finally produced clearance, which is a formal permission to bring a technology to patients.
1:30
Joseph M. Schwab: But here's the thing about permission.
1:33
Joseph M. Schwab: It doesn't move anything by itself.
1:37
Joseph M. Schwab: Clearance tells you that your device is safe and effective by the standards a federal regulator can require.
1:44
Joseph M. Schwab: But what it doesn't tell you is whether a busy surgeon will use it.
1:49
Joseph M. Schwab: Whether a procurement committee will approve it or whether a hospital can absorb it into its workflow or whether a patient will ever know it exists.
2:03
Joseph M. Schwab: In other words, clearance isn't adoption, and for many med tech innovators, the gap between those two things turns out to be just as hard to close as the valley they already crossed to get it cleared in the first place.
2:34
Joseph M. Schwab: You're gonna hear from many people in this episode who have lived on both sides of this gap.
2:40
Joseph M. Schwab: Clinicians who have introduced technology into clinical practice, innovators who had to earn trust, one operating room at a time, and leaders who have watched brilliant devices sit on shelves because the system around them wasn't ready.
2:58
Joseph M. Schwab: Rather than introducing them one by one, we want you to hear them first in their own words
3:05
Jared Foran: I'm Jared Foran.
3:06
Jared Foran: I'm an orthopedic surgeon in Denver, Colorado.
3:09
Jared Foran: I'm a hip and knee arthroplasty specialist.
3:12
Jared Foran: I'm the Chief Scientific Officer of Forcast Orthopedics, and I'm one of the co-founders.
3:17
Peter Noymer: Hi, my name is Peter Noymer.
3:19
Peter Noymer: I'm the CEO of ForCast Orthopedics.
3:21
Peter Noymer: I'm also a PhD in mechanical engineering.
3:23
Peter Noymer: I've spent nearly 30 years, developing novel drug delivery systems for improving treatments across a number of different therapeutic areas.
3:31
Leo Whiteside: Oh, I'm Leo Whiteside.
3:33
Leo Whiteside: I'm an orthopedic surgeon.
3:34
Leo Whiteside: Just, uh, retired last January.
3:37
Leo Whiteside: Uh, engaged in hip and knee replacement, uh, sort of subspecializing and.
3:43
Leo Whiteside: Uh, infected arthroplasty.
3:46
Doug Fairbanks: My name is Doug Fairbanks.
3:47
Doug Fairbanks: I'm the president, CEO, and board member at VISIE Inc.
3:50
Marie-Isabelle Batthyány: My name is Marie-Isabelle Batthyány I'm an board certified anesthesiologist specializing in orthopedic anesthesia and I'm also the founder and CEO of XRSynergies.
4:03
Charlie DeCook: My name is Charlie DeCook.
4:04
Charlie DeCook: I'm the president of Total Joint Specialists, a 17 surgeon group here in Atlanta, Georgia.
4:10
Alexander Sah: My name is Alex Sah and I'm a hip and knee surgeon in private practice as medical co-director of the Institute for Joint Restoration in Fremont, California.
4:17
Alexander Sah: I was past president of the Anterior Hip Foundation and currently serve as Chief Medical Officer at Think! Surgical and Chief Innovation Officer at Ospitek.
4:26
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.
4:40
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.
4:48
Simon Mifsud: And we're developing a novel hip replacement system called the Malta Hip.
4:52
Joseph M. Schwab: Together.
4:53
Joseph M. Schwab: Their stories help us understand what adoption actually requires and why.
4:57
Joseph M. Schwab: Earning a place in the operating room takes a completely different kind of work than earning regulatory clearance.
5:04
Joseph M. Schwab: In this episode, we explore three questions that define life after clearance.
5:11
Joseph M. Schwab: First, what changes when an approved product meets real users?
5:17
Joseph M. Schwab: Second, where do intentions and behaviors diverge in practice?
5:23
Joseph M. Schwab: And third, how is success redefined outside controlled settings?
5:30
Joseph M. Schwab: This is the moment where a technology is clinically credible, but must still earn its place in a room that is busy, pressured, and moving fast.
5:41
Joseph M. Schwab: This is chapter seven, beyond Clearance.
5:51
Joseph M. Schwab: There's a phrase that experienced MedTech leaders use when a product gets cleared, they call it the beginning of the real work, not the end of it.
6:02
Joseph M. Schwab: Regulatory clearance changes your legal status.
6:05
Joseph M. Schwab: It doesn't change human behavior.
6:08
Joseph M. Schwab: It doesn't change institutional inertia, and it doesn't change the fact that every operating room in the country already has routines and preferences and habits that have been built over years, sometimes over decades.
6:24
Joseph M. Schwab: So when a cleared product enters that environment, it's not entering a vacuum.
6:29
Joseph M. Schwab: It's entering an occupied space, and the first question it has to answer is not, is this safe?
6:37
Joseph M. Schwab: The regulator already answered that.
6:39
Joseph M. Schwab: The question it has to answer now is, is this worth the disruption?
6:46
Joseph M. Schwab: And that's a very different question.
6:48
Joseph M. Schwab: Answering it well is what separates products that get used from products that get shelved.
6:56
Joseph M. Schwab: And this is where our first question begins.
6:59
Joseph M. Schwab: So what changes when an approved product meets real users?
7:09
Joseph M. Schwab: In controlled environments, innovation is evaluated for safety and performance under defined conditions in the real world.
7:17
Joseph M. Schwab: It's evaluated for something else entirely disruption.
7:22
Joseph M. Schwab: Not whether it works, but whether it's worth what it costs in time and attention and training and workflow change to make it part of daily practice.
7:34
Joseph M. Schwab: There's a well-established framework in innovation research that helps explain how this plays out.
7:41
Joseph M. Schwab: Sociologist Everett Rogers introduced Diffusion of Innovations theory.
7:48
Joseph M. Schwab: As early as 1962, and it remains one of the most cited bodies of work across all social sciences.
7:56
Joseph M. Schwab: Rogers found that new technologies don't spread because they're good.
8:02
Joseph M. Schwab: They spread.
8:04
Joseph M. Schwab: When people in a community see a clear advantage, recognize compatibility with their existing practices and.
8:15
Joseph M. Schwab: Can observe results in others before fully committing themselves In healthcare, this process is especially visible because the stakes of getting it wrong are unusually high.
8:28
Joseph M. Schwab: A surgeon adopting a new device isn't just changing a tool.
8:33
Joseph M. Schwab: They're changing their workflow or their team's workflow and their patient's outcome all at once.
8:40
Joseph M. Schwab: Rogers also described this process as moving through five stages, knowledge, persuasion, decision, implementation, and confirmation.
8:52
Joseph M. Schwab: And in a hospital environment.
8:54
Joseph M. Schwab: Each of those stages involves multiple stakeholders, not just one.
8:59
Joseph M. Schwab: Research on surgical technology adoption is consistent on one point.
9:04
Joseph M. Schwab: Clinical outcomes are the single highest priority criterion that guides both surgeons and hospital administrators when evaluating something new.
9:15
Joseph M. Schwab: But here's the part that surprises people.
9:19
Joseph M. Schwab: Evidence of clinical benefit is necessary.
9:22
Joseph M. Schwab: But it's not sufficient.
9:25
Joseph M. Schwab: The technology also has to fit the room.
9:29
Joseph M. Schwab: It's walking into and the first thing it encounters is judgment.
9:34
Joseph M. Schwab: From regulators, but from users.
9:37
Joseph M. Schwab: Doug Fairbanks describes what matters most in the operating room at the moment of that judgment.
9:43
Doug Fairbanks: in surgery I wanna tell the surgeon where the anatomy is, because that's the whole question.
9:49
Joseph M. Schwab: But it contains the entire logic of real world adoption in a single sentence.
9:54
Joseph M. Schwab: The value proposition isn't the technology, it's the answer to the question The surgeon is already asking in the moment they need it.
10:02
Joseph M. Schwab: If a product delivers that answer clearly and reliably, the case nearly makes itself.
10:09
Joseph M. Schwab: If it requires the surgeon to reframe the question or wait for the answer or manage additional cognitive load to get there, the disruption cost starts to outweigh the clinical benefit.
10:24
Joseph M. Schwab: And this is where many med tech companies miscalculate after clearance.
10:29
Joseph M. Schwab: They've spent years proving what the device can do.
10:33
Joseph M. Schwab: Then they enter the market and discover there's a translation problem between the evidence they built and the question being asked in real time in a real or.
10:47
Joseph M. Schwab: Robert Cohen has watched this pattern repeat across his career inside startups and inside large organizations, and he points to a specific misallocation of resources that happens after clearance, one that compounds the translation problem rather than solving it.
11:06
Robert Cohen: So many people don't invest in robust clinical data.
11:09
Robert Cohen: If it's clinical data or proper follow ups in the interest that they put, and they build way too much inventory.
11:15
Robert Cohen: Instead of going to 25 sites, ask.
11:18
Robert Cohen: I just went to 10 sites.
11:20
Robert Cohen: Save some of that money on inventory, save some of that money on IRBs for clinical research studies, and actually put it in getting more out of the 10 sites.
11:30
Robert Cohen: You may not need 10,000 patients, 250 patients may show what you need.
11:35
Joseph M. Schwab: What Robert is describing is a strategic reorientation that happens after clearance.
11:41
Joseph M. Schwab: The question shifts from can it work to where does it work best and with whom?
11:47
Joseph M. Schwab: And the answer to that question determines everything, which sites you invest in first, how you build the evidence that will convince the next wave of adopters and how efficiently you use the capital that's still running down.
12:04
Joseph M. Schwab: This matters, especially in orthopedics, where the diffusion of innovation curve can look very different from what happens in consumer technology.
12:12
Joseph M. Schwab: Adoption of innovative surgical technologies is a complex multifaceted process that involves surgeons and hospital administrators and procurement specialists, and increasingly.
12:24
Joseph M. Schwab: Value-based purchasing committees.
12:27
Joseph M. Schwab: Studies have shown that surgeons who become early adopters tend to be opinion leaders with significant peer influence.
12:35
Joseph M. Schwab: If a well-respected surgeon at a major center adopts a device and reports positive outcomes, that creates a ripple effect.
12:44
Joseph M. Schwab: That eventually moves the early majority, but getting to that first credible early adopter requires a specific kind of commitment from the company.
12:55
Joseph M. Schwab: Not just access, but accompaniment, education, training, troubleshooting, and genuine clinical partnership.
13:05
Joseph M. Schwab: For Marie-Isabelle Batthyány, the real world signal that her VR based patient education platform was working came not from a submission or a slide deck, but from patients under real conditions,
13:20
Marie-Isabelle Batthyány: they compared patient satisfaction with 3D videos and vr, and the results were nearly embarrassingly high in favors to vr.
13:31
Marie-Isabelle Batthyány: Being in a nice comfy room, you you're not distracted.
13:34
Marie-Isabelle Batthyány: It works wonders on concentration and recall.
13:37
Joseph M. Schwab: Real users redefined value, and they raised the bar far beyond what approval had required.
13:44
Joseph M. Schwab: Not because the regulators set the floor too low, but because patients given a better experience respond in ways that controlled environments simply don't capture better recall, better preparation, less anxiety, those outcomes matter clinically, but they also matter commercially.
14:06
Joseph M. Schwab: Because they're the kind of evidence that moves administrators and payers and other clinical adopters.
14:13
Joseph M. Schwab: So here's our first answer.
14:15
Joseph M. Schwab: When an approved product meets real users, the evaluation criteria change entirely.
14:23
Joseph M. Schwab: Safety and effectiveness under protocol are replaced by a more demanding and more human set of questions.
14:30
Joseph M. Schwab: Does this answer what I'm already asking?
14:33
Joseph M. Schwab: Does the benefit outweigh the disruption and does it change something for the patient?
14:39
Joseph M. Schwab: In a way I can see and feel the products that earn a permanent place in real world practice are the ones that answer all three.
14:49
Joseph M. Schwab: And answering them well requires understanding not just the clinical problem you solved, but the human context.
14:57
Joseph M. Schwab: The solution has to fit.
15:00
Joseph M. Schwab: Here's the uncomfortable truth that follows from everything we just discussed.
15:04
Joseph M. Schwab: Most of the people who will eventually use a new technology start out as skeptics.
15:11
Joseph M. Schwab: Not because they're resistant to change, but because skepticism is rational.
15:17
Joseph M. Schwab: Especially in a high stakes environment, clinicians are trained to be cautious.
15:22
Joseph M. Schwab: Hospitals are trained to be deliberate, and both of those instincts serve patients well most of the time.
15:32
Joseph M. Schwab: The challenge for any innovator entering this environment is that good intentions on both sides don't automatically produce behavior change.
15:43
Joseph M. Schwab: A surgeon may genuinely want to improve outcomes.
15:47
Joseph M. Schwab: A hospital may genuinely want to reduce complications, and a company may genuinely have a product that does both of those things, but none of that means the behavior change actually happens.
16:01
Joseph M. Schwab: Which leads us to question two.
16:04
Joseph M. Schwab: Where do intentions and behaviors diverge in practice?
16:15
Joseph M. Schwab: There's a concept of behavioral science called the intention behavior gap.
16:20
Joseph M. Schwab: It's the space between what people say they'll do and what they actually do.
16:26
Joseph M. Schwab: And in healthcare, the gap is wide, well documented, and directly relevant to every product that has ever entered a clinical market.
16:36
Joseph M. Schwab: Research on surgical technology adoption is consistent.
16:40
Joseph M. Schwab: Even when surgeons express strong interest in a new device, actual adoption is shaped by a workflow fit and training burden, and team dynamics and institutional support.
16:51
Joseph M. Schwab: A 2023 study in JAMA Surgery examining decision-making criteria for early adoption of innovative surgical technologies, found that clinical outcomes were the top priority.
17:04
Joseph M. Schwab: But they were followed closely by factors like ease of use, impact on or efficiency, and the perception of peer behavior, meaning whether people, the surgeon respects were already using the technology.
17:20
Joseph M. Schwab: The last factor, the peer influence variable is the one that often determines whether adoption accelerates or plateaus.
17:30
Joseph M. Schwab: Everett Rogers called these individuals early adopters, and he defined them as the most important people in any diffusion process.
17:39
Joseph M. Schwab: They make up roughly 13.5% of any population, and their distinctive quality is not just that they adopt early, it's that they're credible enough that when they adopt others follow.
17:55
Joseph M. Schwab: In surgical specialties, these early adopters tend to have engineering oriented mindsets.
18:02
Joseph M. Schwab: They're comfortable with uncertainty.
18:04
Joseph M. Schwab: They see the potential before the evidence base is complete, and their opinion matters disproportionately to the broader market.
18:14
Joseph M. Schwab: Simon Mifsud describes exactly this dynamic and how he's thinking about launching the
18:22
Simon Mifsud: we are going to carefully launch this product, um, train the people that are gonna use it well, um, and those initial sort of early users, we would hope would help us to kind of roll out, uh, the use of the device in a, in a very structured, organized way,
18:41
Joseph M. Schwab: Deliberate rollout isn't a concession to slow adoption.
18:44
Joseph M. Schwab: It's a strategy.
18:46
Joseph M. Schwab: For accelerating it.
18:47
Joseph M. Schwab: When you get the early adopters right and you build the evidence base with them carefully, you create the conditions for the early majority to follow.
18:58
Joseph M. Schwab: When you rush and try to be everywhere, all at once, you risk diluting the training or straining the support and producing inconsistent results that skeptics will use to justify staying away.
19:16
Joseph M. Schwab: The early adopters themselves aren't randomly distributed across a specialty.
19:21
Joseph M. Schwab: They have identifiable characteristics.
19:25
Simon Mifsud: those surgeons that we've shown it to, that perhaps have a more engineering focused mind, get it straight away.
19:33
Simon Mifsud: They get what it could possibly offer and, it's gonna be those guys, I guess that will probably put the hand up and use it first,
19:41
Joseph M. Schwab: This is not an accident of personality, it's the diffusion curve.
19:45
Joseph M. Schwab: Operating exactly as theory predicts.
19:48
Joseph M. Schwab: The engineering minded surgeon, the one who asks, how does it work?
19:52
Joseph M. Schwab: Before asking, how does it compare?
19:55
Joseph M. Schwab: Is the innovator profile.
19:57
Joseph M. Schwab: They're drawn to the underlying mechanism.
20:00
Joseph M. Schwab: They're comfortable with early stage uncertainty, and they're the ones who will generate the real world data.
20:08
Joseph M. Schwab: That eventually persuades the early majority, but there's another dimension to adoption that exists entirely outside of the surgeon's individual decision.
20:19
Joseph M. Schwab: Even when a surgeon is fully on board, the technology still has to survive the procurement process and the nursing team's workflow and the OR schedule, and the postoperative handoff.
20:29
Joseph M. Schwab: Adoption isn't a single decision made by one person.
20:33
Joseph M. Schwab: It's a collective behavior and the collective is harder to move than any individual within it.
20:42
Joseph M. Schwab: Alex Sah has introduced multiple technologies into orthopedic practice and his framework for evaluating whether something will stick is built entirely around that collective reality.
20:54
Alexander Sah: technologies are, products that are most impactful are the ones that speak for themselves.
20:59
Alexander Sah: If a surgeon can use it, they can see the impact immediately.
21:03
Alexander Sah: Then adoption is gonna be rapid.
21:05
Alexander Sah: The new ideas that take a lot of explaining or training, or have other hurdles to adoption or have real challenges to change current practice.
21:12
Alexander Sah: So I think simplicity and immediate and tangible benefit are really important to new products, trying to make a difference in our current practice today.
21:21
Joseph M. Schwab: Simplicity here doesn't mean the technology has to be.
21:25
Joseph M. Schwab: Basic, it means the value has to be immediately legible to the person using it.
21:32
Joseph M. Schwab: If a surgeon picks up an instrument and within the first use can feel a difference, the case nearly makes itself.
21:40
Joseph M. Schwab: If the surgeon picks it up and needs three training sessions before the benefit becomes visible, they're being asked to believe on credit.
21:49
Joseph M. Schwab: And in a busy practice under time pressure with a full operating board, most people won't do that.
21:58
Joseph M. Schwab: Alex Sah has another practice that speaks directly to the intention behavior gap, and it's one of the most practically useful ideas in this episode.
22:08
Joseph M. Schwab: He intentionally withholds information from his team when he introduces something new.
22:14
Alexander Sah: I specifically try to not tell them when I'm using something new because I would really like to objectively hear their experience from their point of care Is what I'm adopting making a difference on their end?
22:26
Joseph M. Schwab: That is one of the most practical feedback loops available to any clinician evaluating a new device because the OR team and the scrub tech and the circulating nurse and the anesthesiologist.
22:38
Joseph M. Schwab: They experience the technology differently than the surgeon does.
22:42
Joseph M. Schwab: They feel the time pressure, they manage the extra steps, and their honest unprimed reaction tells you whether the disruption is real or imagined.
22:54
Joseph M. Schwab: This is also why implementation.
22:56
Joseph M. Schwab: Failure in MedTech is often not a product problem.
22:59
Joseph M. Schwab: It's a team and workflow problem that never got solved before the product launched.
23:07
Joseph M. Schwab: Charlie DeCook offers a perspective on this that's worth sitting with because it's more direct than most people in the industry will be, publicly.
23:18
Charlie DeCook: We knew fundamentally the reason why surgical impaction would be adopted.
23:23
Charlie DeCook: It's'cause frankly, it made it simpler for the surgeon.
23:27
Charlie DeCook: It's, it may not ever prove out that it's better for the patient.
23:32
Charlie DeCook: As long as it proves out that it's at least as good as using what we've been using for 3000 years.
23:37
Charlie DeCook: Even when you do that, it's hard to ever prove out it does any better to a patient.
23:43
Charlie DeCook: It's all been about capitalism, market share.
23:47
Charlie DeCook: That's what it's truly been about.
23:49
Joseph M. Schwab: That is a frank description of the tension that lives at the heart of MedTech adoption.
23:54
Joseph M. Schwab: Clinical benefit drives the ideal.
23:57
Joseph M. Schwab: Market behavior, meaning what actually gets purchased and used at scale is often driven by a different set of forces.
24:05
Joseph M. Schwab: Simplicity for the surgeon, efficiency for the hospital, economic incentive for the system.
24:12
Joseph M. Schwab: The innovations that last are the ones that satisfy both dimensions.
24:18
Joseph M. Schwab: They deliver genuine clinical value and they fit the system that they're entering.
24:24
Joseph M. Schwab: The ones that satisfy only one of those dimensions often find themselves in a frustrating middle ground, clinically credible, but commercially stalled.
24:35
Joseph M. Schwab: So here's the second answer.
24:38
Joseph M. Schwab: Intentions and behaviors.
24:40
Joseph M. Schwab: Divergent practice because adoption is not a single decision.
24:46
Joseph M. Schwab: It's a collective behavior shaped by teams and routines and training burdens, workflow pressures, and the deeply rational skepticism.
24:56
Joseph M. Schwab: Of people who have seen other technologies promise more than they delivered, the products that close the gap are the ones that make the value immediately visible and reduce the disruption to near zero and give every person in the room, not just the surgeon, a reason to trust the technology from the first time they encounter it.
25:18
Joseph M. Schwab: Once the technology survives its first encounters with real users, something interesting begins to happen.
25:25
Joseph M. Schwab: Success stops meaning what it meant during development.
25:32
Joseph M. Schwab: During clinical trials, success means hitting endpoints during regulatory review.
25:38
Joseph M. Schwab: Success means meeting standards.
25:40
Joseph M. Schwab: During fundraising success means demonstrating de-risking milestones.
25:47
Joseph M. Schwab: But once a device is in daily practice, success is defined by the people using it and by the patients they're treating.
25:55
Joseph M. Schwab: And that definition is broader, messier and ultimately more meaningful than any of the earlier versions.
26:05
Joseph M. Schwab: Which brings us to question three.
26:08
Joseph M. Schwab: How is success redefined outside controlled settings?
26:18
Joseph M. Schwab: In a controlled clinical trial, you're measuring what you set out to measure.
26:23
Joseph M. Schwab: You define the endpoints in advance, you standardize the conditions, and you report what the protocol specified.
26:30
Joseph M. Schwab: The process is essential and the evidence it generates is what earns regulatory clearance, but it's a narrow slice of what a technology actually does.
26:41
Joseph M. Schwab: Once it's out in the real world, outside controlled settings, success is multidimensional.
26:48
Joseph M. Schwab: It includes the clinical outcomes, the trials measured, but it also includes things that trials almost never capture, whether the nursing team runs a smoother turnaround, whether the scheduler can reliably add another case, whether the patient spends fewer nights in the hospital, and whether the hospital's economics actually improve over time.
27:13
Joseph M. Schwab: Robert Cohen describes what real world success looks like when all of those dimensions align at scale.
27:21
Robert Cohen: you increase patient satisfaction, reduce complications, reduce emissions, reduce reoperations, and increase efficiencies and better workflows.
27:31
Robert Cohen: That's a home run.
27:32
Robert Cohen: That's what all of us companies are looking for, and that's the expectation of all these great technologies coming together at the same time.
27:39
Joseph M. Schwab: Notice that list patient satisfaction.
27:43
Joseph M. Schwab: Complications, re-operations, efficiencies, workflows.
27:49
Joseph M. Schwab: That's not a clinical trial endpoint list, that's a healthcare systems outcome list.
27:57
Joseph M. Schwab: It reflects the full complexity of what innovation is supposed to deliver when it reaches patients at scale and in our specific area of arthroplasty and periprosthetic joint infection.
28:10
Joseph M. Schwab: The economic dimension of that list.
28:13
Joseph M. Schwab: Isn't abstract.
28:14
Joseph M. Schwab: The numbers are staggering and well-documented in literature and the economics behind those outcomes matter enormously in our specific area.
28:24
Joseph M. Schwab: Research published in the Journal of Arthroplasty projected that the combined annual hospital costs related to PJI of the hip and knee in the United States will reach$1.85 billion by 2030.
28:40
Joseph M. Schwab: Treatment costs for PJI run between three and five and a half times higher.
28:47
Joseph M. Schwab: Then those of primary arthroplasty, the mortality rate following PJI after total hip ranges from four to 8% at one year, and the per patient burden.
28:59
Joseph M. Schwab: When you factor in revision surgery, prolonged antibiotic therapy, extended hospital stays lost productivity, and the psychological impact on patients routinely reaches into the six figure range.
29:14
Joseph M. Schwab: Peter Noymer captures the economic argument in terms that any payer or hospital administrator or value-based care committee will immediately understand.
29:24
Peter Noymer: the health economics in the PJI space are, are pretty horrible, and that's driven largely by the failure rates that we see now.
29:31
Peter Noymer: Um, the burden on the healthcare system, on a, on a per patient basis, um, easily gets into the six figure dollars and, and often into seven figures, so that's a huge drain on the healthcare system.
29:42
Peter Noymer: And so obviously by moving the needle, you can get to something that has better outcomes for patients, um, you know, better for the bottom line for the hospitals and the insurers, and there's still room in there for reasonable profit margin for a company to sustain itself.
29:59
Joseph M. Schwab: That framing better outcomes for patients, better economics for the system, and a viable business model for the company is what most durable med tech innovations eventually demonstrate, not in a trial, in practice, and over time across a diverse population of patients and institutions.
30:21
Joseph M. Schwab: This is what the broader innovation literature calls real world evidence, and it's increasingly what health systems and payers require.
30:31
Joseph M. Schwab: Before they commit to a technology at scale, the FDA itself has recognized this shift.
30:37
Joseph M. Schwab: In late 2025, the agency updated its guidance to allow de-identified real world evidence in certain medical device submissions, explicitly acknowledging that the previous standards had created barriers to using the most valuable data that practice actually generates.
30:57
Joseph M. Schwab: Policy shift reflects a deeper truth about how meaningful clinical innovation actually works.
31:05
Joseph M. Schwab: The control trial proves biological plausibility, real world performance proves value, and the bridge between those two is adoption.
31:19
Joseph M. Schwab: Which is why the work of this episode matters as much as any of the earlier ones for Jared Foran.
31:27
Joseph M. Schwab: The signal that the technology is approaching real world readiness is coming from the people who have seen the data and are waiting for access.
31:37
Jared Foran: the feedback is they just can't wait to use it.
31:41
Jared Foran: When can I get this in my hands?
31:43
Jared Foran: That's, I hear over and over.
31:44
Jared Foran: And they've seen the data, they know the, the, the biofilm eradication concentration numbers that we can get to, and it's exciting.
31:50
Joseph M. Schwab: That kind of anticipatory demand is something innovators work toward for years.
31:56
Joseph M. Schwab: It means the evidence has done its job.
31:59
Joseph M. Schwab: It means the early adopters have been identified and engaged, and it means the next conversation is no longer about whether the technology might work.
32:10
Joseph M. Schwab: It's about when it'll be available.
32:14
Joseph M. Schwab: There's also something important in how Jared describes the surgeons expressing that enthusiasm.
32:20
Joseph M. Schwab: They know the specific pharmacological numbers.
32:23
Joseph M. Schwab: They understand the biofilm eradication concentration data.
32:28
Joseph M. Schwab: They're not responding to marketing, they're responding to science, and that is a kind of adoption that sustains itself.
32:38
Joseph M. Schwab: The clinical rationale is embedded in the user's own understanding, not borrowed from a sales call.
32:47
Joseph M. Schwab: What follows from that kind of adoption over time is a shift in what standard practice looks like.
32:54
Joseph M. Schwab: Not a dramatic announcement, not a headline, maybe at a conference, just a gradual normalization where the new approach begins to feel.
33:06
Joseph M. Schwab: Like the expected approach
33:08
Jared Foran: I think that in the not too distant future that, you know, future generations orthopedic surgeons are gonna be using this tech technique, intraarticular infusion, and they're not gonna imagine a world where we didn't use to use it.
33:18
Joseph M. Schwab: That isn't hyperbole.
33:21
Joseph M. Schwab: That is the description of a technology crossing the critical mass threshold that Rogers identified in diffusion theory.
33:29
Joseph M. Schwab: Once enough respected adopters are using something, and once the evidence base from real world practice is deep enough, the innovation stops being a choice among alternatives, it becomes the baseline.
33:45
Joseph M. Schwab: The expectation and eventually the standard of care.
33:51
Joseph M. Schwab: Leo Whiteside has spent decades working at the frontier of infection management in arthroplasty, and the results he describes from prolonged intraarticular antibiotic infusion represent exactly the kind of real world outcome that creates that baseline shift.
34:09
Leo Whiteside: we could get huge doses of antibiotics, we could do it daily, we could do it for six weeks, and that outperformed everything.
34:17
Leo Whiteside: There's nothing that's, that's been as effective as that.
34:21
Leo Whiteside: I was getting 95% success rate with it.
34:24
Leo Whiteside: And, uh, there's no reason not to if you have a meticulous surgical group, and, uh, then a dedicated team to take care of this patient afterward.
34:35
Joseph M. Schwab: 95%.
34:38
Joseph M. Schwab: That's not controlled trial endpoints.
34:41
Joseph M. Schwab: That is a practice outcome built over years by a dedicated team operating with a refined protocol, and that number carries a different kind of weight.
34:54
Joseph M. Schwab: Than just a P value.
34:56
Joseph M. Schwab: It carries the weight of real patients and real infections and real results.
35:02
Joseph M. Schwab: But Leo also adds a condition that matters enormously for real world success, a meticulous surgical group, and a dedicated team.
35:12
Joseph M. Schwab: Afterward, the technology doesn't operate in isolation.
35:18
Joseph M. Schwab: It operates inside a system of people, and the outcomes are only as good as the human infrastructure supporting them, which is precisely what success means.
35:29
Joseph M. Schwab: Outside controlled settings, it becomes less about whether the device worked in a protocol and more about whether it works in a practice.
35:39
Joseph M. Schwab: Less about whether endpoints were met in a trial and more about whether the patient went home better.
35:46
Joseph M. Schwab: Whether the complication rate decreased, whether the surgeon felt confident, whether the team ran smoothly, and whether the institution can sustain that approach at scale.
36:02
Joseph M. Schwab: So here's our third answer.
36:04
Joseph M. Schwab: Outside controlled settings, success is no longer defined by endpoints.
36:10
Joseph M. Schwab: It's defined by the full operating reality, patient outcomes, system, economics, workflow efficiency, and the durability of adoption over time, and the signal that a technology has truly arrived isn't the clearance letter.
36:29
Joseph M. Schwab: It's the moment when the people using it can't imagine going back.
36:35
Joseph M. Schwab: And at that stage, success is measured in trust.
36:39
Joseph M. Schwab: And trust in medicine is the only measure that actually compounds over time.
36:52
Joseph M. Schwab: Let's step back and answer the three questions we began with across all three of our questions today.
36:58
Joseph M. Schwab: A single theme kept coming back.
37:00
Joseph M. Schwab: Clearance is permission.
37:03
Joseph M. Schwab: Adoption is performance, and the distance between them is where most of the hard and unglamorous and deeply human work.
37:14
Joseph M. Schwab: Of innovation happens in the first question.
37:17
Joseph M. Schwab: We learn that when an approved product meets real users, the evaluation criteria change entirely.
37:25
Joseph M. Schwab: The regulator asked whether it's safe, the surgeon asks whether it's worth it.
37:31
Joseph M. Schwab: Answering that question well requires understanding not just the clinical problem you solved, but the human context the solution has to fit in.
37:42
Joseph M. Schwab: The second question, we learned that intentions and behaviors diverge.
37:48
Joseph M. Schwab: Because adoption is collective, not individual teams and routines and training burdens and peer influence all shape.
37:57
Joseph M. Schwab: Whether a device gets used consistently or quietly disappears.
38:04
Joseph M. Schwab: The innovations that close the intention behavior gap are the ones that make value immediately visible.
38:11
Joseph M. Schwab: Reduce friction to near zero and give the people in the room a reason to trust the technology the first time they use it.
38:22
Joseph M. Schwab: And in the third question, we learn that success outside controlled settings is multi-dimensional.
38:29
Joseph M. Schwab: It is patient satisfaction.
38:31
Joseph M. Schwab: Reduced reoperations, better health, economics, and a practice that gradually shifts until the new approach becomes the expected approach.
38:42
Joseph M. Schwab: The proof is not the trial result.
38:45
Joseph M. Schwab: It's the surgeon who can't imagine going back.
38:49
Joseph M. Schwab: And if you take away one thing from this episode, let it be this, the finish line is not clearance.
38:57
Joseph M. Schwab: It's not even adoption.
38:59
Joseph M. Schwab: The finish line is the moment a patient receives better care, because someone probably years earlier decided not to look away from a problem everyone else had learned to live with everything in this episode, the real world evaluation and the behavioral friction and the redefinition of success in practice, all of it exists in service of that one outcome.
39:26
Joseph M. Schwab: That is what?
39:27
Joseph M. Schwab: This work is for, and when that moment finally arrives, when the patient is better, when the surgeon can't imagine going back and when the practice had shifted a new reality sets in, now you have to deliver it every time at scale to everyone.
39:54
Joseph M. Schwab: Or at least everyone who needs it because building one is engineering.
40:01
Joseph M. Schwab: Building 10,000 is a completely different discipline, and the companies that confuse the two often find out the hard way.