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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

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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.

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FITM Extended Interview: Simon Mifsud (Garland Surgical, Ltd.)