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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