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Garland Surgical's flagship product, the TriActiv Hip (formerly known as the MaltaHip), replaces the ball-and-socket geometry that has defined hip arthroplasty for 120 years with a cylindrical bearing system inspired by the biomechanics of the ankle joint. Simon Mifsud, CEO of Garland Surgical, explains how this design virtually eliminates dislocation risk and reduced wear by 75 percent in accelerated testing.

Mifsud walks through how the cylindrical design achieves its stability advantage — larger contact area, linear reciprocating motion that avoids cross-shear of the polymer — and why surgeons at AAOS and ACUS told him stability matters far more to them right now than durability. He describes the four patient populations this technology targets, from chronic dislocators and post-spinal-fusion patients to the roughly half of the global population whose daily activities involve squatting and cross-legged sitting. The TriActiv Hip stays in place through all of it while offering range of motion that constrained liners cannot match.

https://www.garlandsurgical.health/

The business story is just as instructive. Garland Surgical is a University of Malta spinout navigating a pre-revenue funding landscape where deep-tech hardware competes against AI and digital health for investor attention. Mifsud shares how a hybrid of equity and non-dilutive grant funding — including a 1.4 million euro Malta Enterprise award — has kept the company moving, and how a successful FDA Q-sub cleared the biggest objection investors had. For innovators building physical devices in a software-obsessed market, this is a roadmap worth studying.

⏱️ Chapters:
00:00 Introducing Simon Mifsud and the TriActiv Hip
00:49 Why ankle biomechanics inspired a new hip design
02:54 Four underserved patient populations
06:19 How cylindrical bearings reduce wear debris
08:18 What "a hip for life" really means
09:41 Proof of concept: cadaver surgery and the garland pose
11:03 Cross-compatibility with existing femoral stems
13:11 Licensing model versus becoming an OEM
15:04 FDA 510(k) pathway and regulatory strategy
16:01 UK launch, ODEP, and training early adopters
17:26 Funding a hardware startup in a software-first market
20:23 How investor feedback shaped the regulatory approach
23:15 What surgeons at AAOS and ACUS actually wanted
26:46 Managing relationships with academic co-inventors
29:26 Where the TriActiv Hip fits in five years
33:27 What "from idea to market" means to Garland Surgical

Listen to the AHF Podcast on your preferred platform:
Buzzsprout: https://ahfpodcast.buzzsprout.com
Apple Podcasts: https://podcasts.apple.com/us/podcast/ahf-podcast/id1749521487
Spotify: https://open.spotify.com/show/5CrGJyvRiQFTCU3FFFVvHc
LinkedIn: https://www.linkedin.com/showcase/ahf-podcast
YouTube: https://www.youtube.com/@anteriorhipfoundation
Homepage: https://anteriorhipfoundation.com

This podcast is intended for educational and informational purposes only.

The content discussed does not constitute medical advice and should not be used as a substitute for professional judgment. Clinicians should rely on their own training, experience, and clinical decision-making when applying information from this discussion.

#AnteriorHipFoundation #AHFPodcast #TriActivHip #GarlandSurgical #HipReplacement #TotalHipArthroplasty #THA #HipDislocation #CylindricalBearing #MedicalDeviceStartup #SimonMifsud #HipForLife #510k #OrthopedicInnovation

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Your device just got FDA clearance. So why isn't anyone using it? In this episode of From Idea to Market, Joe Schwab and a panel of surgeons, engineers, and MedTech leaders explore why regulatory approval is only the beginning — and what it actually takes to earn a place in the operating room.

Clearance tells you a device is safe and effective. It doesn't tell you whether a busy surgeon will change their workflow, whether a procurement committee will approve it, or whether a hospital can absorb it into daily practice. This episode unpacks the gap between permission and performance — the space where most MedTech innovations either earn trust or stall out.

Drawing on Everett Rogers' Diffusion of Innovations theory and recent research on early adoption decision-making in surgery, the conversation examines why clinical evidence alone isn't enough. Guests describe how simplicity, immediate benefit, team dynamics, and peer influence determine whether a technology sticks — and why the intention-behavior gap in surgical practice is wider than most companies expect.

The panel also explores how success is redefined after clearance, moving from trial endpoints to real-world outcomes including patient satisfaction, complication rates, workflow efficiency, and health economics. In the PJI space alone, annual hospital costs are projected to reach $1.85 billion by 2030, giving technologies that move the needle enormous clinical and economic significance.

⏱️ Chapters:
00:00 Introduction and series overview
02:34 Meet the panel
05:47 Why clearance is only the beginning
07:42 Diffusion of innovations in surgery
11:07 Investing in data vs inventory after clearance
16:11 The intention-behavior gap in adoption
18:14 Deliberate rollout and early adopter strategy
20:55 Simplicity as the key to surgical adoption
23:18 Market forces behind technology uptake
26:19 Redefining success outside controlled settings
29:24 PJI economics and the case for innovation
33:19 When innovation becomes the standard of care
36:52 Three lessons from life after clearance

Listen to the AHF Podcast on your preferred platform:
Buzzsprout: https://ahfpodcast.buzzsprout.com
Apple Podcasts: https://podcasts.apple.com/us/podcast/ahf-podcast/id1749521487
Spotify: https://open.spotify.com/show/5CrGJyvRiQFTCU3FFFVvHc
LinkedIn: https://www.linkedin.com/showcase/ahf-podcast
YouTube: https://www.youtube.com/@anteriorhipfoundation
Homepage: https://anteriorhipfoundation.com

This podcast is intended for educational and informational purposes only.

The content discussed does not constitute medical advice and should not be used as a substitute for professional judgment. Clinicians should rely on their own training, experience, and clinical decision-making when applying information from this discussion.

#AnteriorHipFoundation #AHFPodcast #MedTechAdoption #RegulatoryStrategy #FDAClearance #DiffusionOfInnovations #SurgicalInnovation #TotalHipArthroplasty #PJI #PeriprostheticJointInfection #RealWorldEvidence #OrthopedicSurgery #FromIdeaToMarket #MedicalDeviceAdoption

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Charlie DeCook has exited seven medical device companies while performing 1,500 joint replacements a year — all packed into three clinical days per week. In this extended interview, he breaks down exactly how he evaluates new technologies and why he now filters every opportunity through an AI and robotics lens.

DeCook traces his entrepreneurial arc from his first venture in surgical impaction — a product that eventually sold to Johnson & Johnson and became Kincise — through to his current focus on software-driven solutions. He explains why the "jobs to be done" framework from Clayton Christensen's Innovator's Dilemma is the foundation of every product he touches, and why surgeons who skip the financial model are setting themselves up for years of pain. Along the way, he offers a candid look at how large device companies operate, including the "slow no" that strings inventor-surgeons along for months without a real commitment.

The conversation also covers the AHF Shark Tank program and what separates pitches that land from those that get eaten alive. Whether you are a surgeon sitting in the OR frustrated with an inefficiency, or a founder trying to get traction with the big three, DeCook's hard-won playbook is worth hearing in full.

⏱️ Chapters:
00:00 Meet Charlie DeCook — surgeon, serial entrepreneur
02:11 First venture: surgical impaction to Johnson & Johnson
03:29 Filtering ideas with easier, faster, better
05:22 Patient outcomes vs commercial reality in med-tech
07:43 Why cost concerns work themselves out over time
09:02 Strategic shift from hardware to AI and robotics
10:41 Finding innovation through jobs to be done in the OR
12:43 Lessons from ventures that required major pivots
14:49 Protecting IP from large device companies
17:27 Why public companies can't think past the quarter
19:02 Evaluating products beyond your own efficiency lens
21:40 What makes a winning AHF Shark Tank pitch
24:29 Common mistakes surgeon-entrepreneurs make pitching
27:17 Innovation areas the Shark Tank needs more of
29:25 Top advice for surgeons with a great OR idea
31:45 What innovation in orthopedics really means

Listen to the AHF Podcast on your preferred platform:
Buzzsprout: https://ahfpodcast.buzzsprout.com
Apple Podcasts: https://podcasts.apple.com/us/podcast/ahf-podcast/id1749521487
Spotify: https://open.spotify.com/show/5CrGJyvRiQFTCU3FFFVvHc
LinkedIn: https://www.linkedin.com/showcase/ahf-podcast
YouTube: https://www.youtube.com/@anteriorhipfoundation
Homepage: https://anteriorhipfoundation.com

This podcast is intended for educational and informational purposes only.

The content discussed does not constitute medical advice and should not be used as a substitute for professional judgment. Clinicians should rely on their own training, experience, and clinical decision-making when applying information from this discussion.

#AnteriorHipFoundation #AHFPodcast #SurgeonEntrepreneur #MedicalDeviceStartup #OrthopedicInnovation #TotalJointArthroplasty #SurgicalImpaction #AIinOrthopedics #RoboticSurgery #JobsToBeDone #AHFSharkTank #CharlieDeCook #MedTechEntrepreneur #THA

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What actually happens between building a medical device and getting it approved? In this episode of From Idea to Market, we walk through the regulatory valley that separates a working prototype from a cleared product — and why so many promising innovations stall right here.

This is the stage where progress stops being about what you can build and starts being about what you can prove. Joe Schwab breaks down the FDA's device classification system, the critical difference between 510(k) and PMA pathways, and why the gap between regulatory clearance and reimbursement has become one of the defining challenges in modern med tech. You'll hear from founders and industry veterans — including Jared Foran, Peter Noymer, Doug Fairbanks, Marie-Isabelle Batthyány, Robert Cohen, and Simon Mifsud — who share hard-won lessons about navigating this process with limited capital and no margin for error.

Whether you're a surgeon with a device idea, an engineer entering the med tech space, or an investor trying to understand what makes regulatory risk so difficult to price, this episode maps the valley in concrete terms — and explains why the teams that survive it tend to build better products because of it.

⏱️ Chapters:
00:00 Introduction to the regulatory valley
02:21 Meet the founders and industry veterans
04:36 Why promising devices stall before FDA review
05:23 FDA device classification for hip arthroplasty
09:10 Designing to regulatory standards from day one
10:26 FDA clearance without reimbursement
14:07 How design controls sharpen device claims
16:32 FDA designations that accelerate development
19:56 Costs and risks founders underestimate
23:31 Three lessons from the regulatory valley

Listen to the AHF Podcast on your preferred platform:
Buzzsprout: https://ahfpodcast.buzzsprout.com
Apple Podcasts: https://podcasts.apple.com/us/podcast/ahf-podcast/id1749521487
Spotify: https://open.spotify.com/show/5CrGJyvRiQFTCU3FFFVvHc
LinkedIn: https://www.linkedin.com/showcase/ahf-podcast
YouTube: https://www.youtube.com/@anteriorhipfoundation
Homepage: https://anteriorhipfoundation.com

This podcast is intended for educational and informational purposes only.

The content discussed does not constitute medical advice and should not be used as a substitute for professional judgment. Clinicians should rely on their own training, experience, and clinical decision-making when applying information from this discussion.

#AnteriorHipFoundation #AHFPodcast #FDAApproval #MedicalDeviceRegulation #510k #PMA #TotalHipArthroplasty #MedTechInnovation #DeviceClassification #DesignControls #Reimbursement #OrthopedicSurgery #ValleyOfDeath #FromIdeaToMarket

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Doug Fairbanks left a robotics commercialization role at Johnson & Johnson to lead a deep tech startup most surgeons had never heard of. In this conversation, the president and CEO of VISIE Inc. explains why — and what their continuous anatomic auto tracking technology could mean for the future of robotic-assisted surgery.

VISIE started as Advanced Scanners, a company founded by optical physicist Aaron Bernstein to solve the problem of brain shift during cranial procedures. Fairbanks saw the technology's potential far beyond neuroscience and joined to steer the company toward orthopedics. The result is a 3D spatial computing platform that tracks anatomy in real time at 254-micron accuracy — without pins, arrays, or registration. Fairbanks walks through how VISIE built all its hardware and software in-house to push the limits of what's possible, why that Apollo 13 engineering mentality defines the company's culture, and what it took to go from four scans per second to over twenty-five.

This episode also covers the business side of deep tech innovation: how VISIE navigates the sub-component regulatory pathway, what partnership conversations with strategic companies actually sound like, how 16 patents in eight months shaped their IP strategy, and why the board in the other room still reads “patients treated: zero.” Whether you're a surgeon curious about pin-free tracking or a founder building something no one has built before, this is a candid look at what it takes to bring genuinely new technology to the operating room.

Learn more about VISIE at https://visievision.com

⏱️ Chapters:
00:00 From neuroscience startup to surgical vision company
03:55 Launching Velys robotics at DePuy Synthes
07:44 What is continuous anatomic auto tracking
11:07 Why VISIE builds all hardware and software in-house
13:54 Teaching robots to see what surgeons see
18:30 The hardest technical challenge at VISIE
21:00 Validating deep tech with the surgical market
25:42 Scaling a startup with contract manufacturing
28:09 Regulatory pathway as a sub-component device
32:00 Protecting innovation with an aggressive IP strategy
35:09 Future of pin-free tracking in hips and knees
37:29 Advice for surgeon innovators starting a company

Listen to the AHF Podcast on your preferred platform:
Buzzsprout: https://ahfpodcast.buzzsprout.com
Apple Podcasts: https://podcasts.apple.com/us/podcast/ahf-podcast/id1749521487
Spotify: https://open.spotify.com/show/5CrGJyvRiQFTCU3FFFVvHc
LinkedIn: https://www.linkedin.com/showcase/ahf-podcast
YouTube: https://www.youtube.com/@anteriorhipfoundation
Homepage: https://anteriorhipfoundation.com

This podcast is intended for educational and informational purposes only.

The content discussed does not constitute medical advice and should not be used as a substitute for professional judgment. Clinicians should rely on their own training, experience, and clinical decision-making when applying information from this discussion.

#AnteriorHipFoundation #AHFPodcast #VISIE #DougFairbanks #PinFreeTracking #SurgicalRobotics #3DScanning #CAAT #OrthopedicInnovation #MedTechStartup #RoboticAssistedSurgery #ComputerVision #SpatialComputing

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Most MedTech founders think financing is about getting enough money to keep building. But once you take capital, it reshapes your governance, your priorities, and your pace — and some consequences don't surface for years.

In this episode of the AHF Podcast's From Idea to Market series, we explore what funding actually buys beyond time and resources, how capital decisions redistribute power within a startup, and which financing consequences only become visible years later. Founders, investors, and legal experts share hard-won lessons about navigating the Valley of Death — from choosing between equity and grants, to the real cost of starting as an LLC, to why royalty agreements shape cash flow long after the ink dries.

Whether you're a surgeon-innovator weighing your first funding round or an engineer planning a device company's financial architecture, this conversation lays out the structural, financial, and human realities of MedTech financing that most pitch decks never mention.

⏱️ Chapters:

00:00 The Valley of Death in MedTech startups

02:37 Meet the founders, investors, and experts

04:40 Startup runway and burn rate explained

06:04 How venture financing rounds work in MedTech

09:42 Grants vs equity and preserving ownership

11:08 How VC fund lifecycles pressure founders

13:06 Finding investors for hardware medical devices

18:16 LLC vs C corporation and hidden structural costs

22:09 Royalty streams and long-tail financial obligations

24:31 Approach financing like clinical design

Listen to the AHF Podcast on your preferred platform:

Buzzsprout: https://ahfpodcast.buzzsprout.com

Apple Podcasts: https://podcasts.apple.com/us/podcast/ahf-podcast/id1749521487

Spotify: https://open.spotify.com/show/5CrGJyvRiQFTCU3FFFVvHc

LinkedIn: https://www.linkedin.com/showcase/ahf-podcast

YouTube: https://www.youtube.com/@anteriorhipfoundation

Homepage: https://anteriorhipfoundation.com

This podcast is intended for educational and informational purposes only.

The content discussed does not constitute medical advice and should not be used as a substitute for professional judgment. Clinicians should rely on their own training, experience, and clinical decision-making when applying information from this discussion.

#AnteriorHipFoundation #AHFPodcast #MedTechStartup #MedicalDeviceFinancing #ValleyOfDeath #VentureCapital #StartupFunding #EquityDilution #RoyaltyAgreements #MedTechInnovation #SurgeonInnovator #FromIdeaToMarket

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Robert Cohen has spent four decades on both sides of the MedTech table — founding companies, selling them, and now evaluating billion-dollar acquisitions as Stryker's VP of Innovation and Technology for Orthopedics. In this conversation, he shares exactly what a global company looks for when it decides whether a startup's technology is worth acquiring.

Cohen's career reads like a timeline of modern orthopedic innovation. He co-founded Implex, the company behind trabecular metal, which was acquired by Zimmer. He then built a 3D printing company that worked closely with Mako Surgical, and when Stryker acquired Mako in what became one of its most successful acquisitions, Cohen came with it — returning to Stryker 23 years after he'd originally left. That rare vantage point, having been the founder pitching and the executive evaluating, shapes every insight in this episode.

From the reimbursement pressures reshaping which innovations get funded, to why founder ego can quietly kill an acquisition, to the 15-minute pitch structure that actually gets a company's attention, this is a conversation for anyone building a medical device and wondering what happens when a big company comes knocking. Cohen also looks ahead at where he'd put $10 million today and why the convergence of digital, AI, and enabling technology makes this the most exciting era in orthopedic innovation.

⏱️ Chapters:
00:00 Four decades of MedTech innovation at Stryker
01:29 From startup founder to global acquisition leader
04:29 How Stryker evaluates technology for acquisition
05:38 Reimbursement challenges in medical device innovation
09:35 Assessing MedTech startups at different stages
12:11 Rising patient expectations and implant engineering
15:18 Why C corporation structure matters for startups
17:44 How founder ego affects acquisition negotiations
20:25 What large companies look for in acquisition targets
24:07 Post-acquisition integration and retaining talent
29:08 How Mako changed orthopedic robotics at Stryker
34:36 Where to invest $10 million in MedTech today
38:17 The 15-minute pitch that gets a company's attention

Listen to the AHF Podcast on your preferred platform:
Buzzsprout: https://ahfpodcast.buzzsprout.com
Apple Podcasts: https://podcasts.apple.com/us/podcast/ahf-podcast/id1749521487
Spotify: https://open.spotify.com/show/5CrGJyvRiQFTCU3FFFVvHc
LinkedIn: https://www.linkedin.com/showcase/ahf-podcast
YouTube: https://www.youtube.com/@anteriorhipfoundation
Homepage: https://anteriorhipfoundation.com

This podcast is intended for educational and informational purposes only.

The content discussed does not constitute medical advice and should not be used as a substitute for professional judgment. Clinicians should rely on their own training, experience, and clinical decision-making when applying information from this discussion.

#AnteriorHipFoundation #AHFPodcast #RobertCohen #Stryker #MakoRobotics #MedTechStartup #OrthopedicInnovation #MedicalDeviceAcquisition #TrabecularMetal #RoboticSurgery #3DPrinting #TotalJointReplacement #MedTechInvestment

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Dr. Sebastian Rodriguez-Elizalde built a same-day anterior hip program inside a Canadian public hospital — not a private surgical center. This conversation covers what it actually takes to change your approach, your team culture, and your system all at once.

Sebastian trained in posterior approach at HSS and transitioned to anterior approach early in his independent career. In this episode, he talks honestly about the ego hit of relearning something you were already good at, the anxiety of operating without a safety net, and the decision to go all-in without giving himself the option to retreat. He describes surgery as choreography — a measured cadence where every team member understands the beats of the day.

What makes this conversation different is the emphasis on system change. Sebastian didn't just get faster in the OR. He brought his entire team to observe high-efficiency programs run by surgeons like Charlie DeCook and Kristoff Corten, then built a hybrid Canadian model from what everyone learned. He explains how overcoming institutional inertia in a public healthcare system requires patience, proof of concept, and the ability to speak the language of administrators, nurses, and anesthesiologists — not just surgeons. Whether you are early in your career or rethinking how your OR runs, this episode offers a practical blueprint for building something better without burning out.

⏱️ Chapters:
00:00 Introduction and guest background
01:39 Why surgery is like choreography
05:58 Why team rhythm matters more than surgeon speed
08:03 Real constraints of a Canadian public hospital system
10:37 Overcoming institutional inertia to drive change
14:11 Post-fellowship growth and learning to lead system change
16:27 How measuring every surgical step changes your practice
18:41 Switching from posterior to anterior approach mid-career
23:19 Going all-in and what it teaches you about ego
26:00 Why the whole team needs to see high-efficiency surgery
30:09 Mistakes surgeons make building rapid discharge programs
32:04 Three non-negotiables for a high-efficiency OR
36:50 Evaluating new technology when every dollar matters
43:18 Career advice and the five percent growth rule

Listen to the AHF Podcast on your preferred platform:

Buzzsprout: https://ahfpodcast.buzzsprout.com
Apple Podcasts: https://podcasts.apple.com/us/podcast/ahf-podcast/id1749521487
Spotify: https://open.spotify.com/show/5CrGJyvRiQFTCU3FFFVvHc
LinkedIn: https://www.linkedin.com/showcase/ahf-podcast
YouTube: https://www.youtube.com/@anteriorhipfoundation
Homepage: https://anteriorhipfoundation.com

This podcast is intended for educational and informational purposes only.

The content discussed does not constitute medical advice and should not be used as a substitute for professional judgment. Clinicians should rely on their own training, experience, and clinical decision-making when applying information from this discussion.

#AnteriorHipFoundation #AHFPodcast #TotalHipReplacement #AnteriorApproach #SameDayHipReplacement #SurgicalEfficiency #RapidDischarge #ORTeamwork #HipArthroplasty #THA #SurgicalEducation #PublicHealthcare #RoboticsInSurgery #SebastianRodriguezElizalde