From instrument drawings to an implant portfolio

Mandate

Prepare the implant and instrument portfolio for the MDR and turn the recovery app into a service hospitals pay for.

Outcomes

• Withdrew a 2004 knee system over thirty months; 38 of its 52 surgeons stayed with Merlicourt
• Replaced unattended app messaging with structured daily questions and a hospital worklist
• Grew recovery-app hospitals from 61 to 96 after opening the programme to all implants at €38 per episode
• Cut standard knee instrument trays from nine to six per procedure

Decisions in context

I became chief product officer just as pandemic restrictions closed elective theatres. My first decisions concerned what the recovery app could safely do for patients whose surgery had been postponed, and what we should decline. Since then my work has followed three lines. The first is the portfolio: we reviewed every implant and instrument system against the MDR, withdrew some and invested in others. The second is the recovery programme, which became a paid hospital service and lost features as well as gaining them. The third is theatre efficiency, where scrub nurses' counts have reduced the instruments we send for each knee procedure. I lead 74 colleagues and a €14.6 million development budget, present the portfolio to the board each quarter and attend its quality and product-safety committee for product items. I am an executive there, not a director.

Reason for the move

Still in post; an external board seat would be added to this role, not replace it.

Mandate

Bring hip and knee product management under one lead and launch the recovery programme as a medical device.

Outcomes

• Launched the recovery app in 2018 after a six-hospital pilot
• Removed a step-count leaderboard after physiotherapists raised safety concerns
• Prepared the app's reclassification and certification work for the MDR

Decisions in context

This role joined responsibility for the implant portfolio with the launch of our first digital product. The recovery app went live in 2018 as a class I device under the former directive, and I learnt that software creates obligations with a different rhythm from implants: frequent releases, complaints arriving through app-store reviews instead of sales representatives, and patients using features in ways we had never intended. The step-count leaderboard was my mistake, and physiotherapists were right to ask us to remove it. I also began preparing for the MDR, under which the app would need notified-body certification as a class IIa device, achieved in 2022. My team grew to 41 people and the development budget to €8.2 million. The chief executive then asked me to take a single role covering implants, instruments and software.

Reason for the move

Asked to become chief product officer when portfolio and digital work needed a single executive owner.

Mandate

Renew the knee range and reduce the instrument variants hospitals had to stock and sterilise.

Outcomes

• Launched the current knee system in 2015 with instrumentation designed alongside theatre nurses
• Grew knee sales from €49 million to €63 million over four years
• Secured funding for the first recovery-programme pilot in 2016

Decisions in context

As director of the knee portfolio I was responsible for every knee system we sold, including the 2004 design I would later recommend withdrawing. We launched our current knee in 2015 with simplified instruments designed with scrub nurses as well as surgeons, which made it easier to adopt in hospitals with tight theatre schedules. The same years produced the first recovery-programme work. Physiotherapists at two customer hospitals described how patients left with photocopied exercises and little support, and I persuaded the chief executive to fund a small pilot in 2016. It leaned too heavily on smartphones, but it showed us what patients would actually use. My team of fourteen covered product management, surgeon education and evidence planning with our medical affairs colleagues. Knee sales grew from €49 million to €63 million, mostly through the new system.

Reason for the move

Promoted to lead hip and knee product management together and launch the recovery app.

Mandate

Support surgeons using two established knee systems and reduce the variants carried in hospital trays.

Outcomes

• Removed seven rarely used instrument variants after hospital counts
• Rewrote both surgical technique guides with advising surgeons
• Supported two post-market clinical studies run by medical affairs

Decisions in context

I came to Namur to manage two knee systems in a company smaller and more informal than the one I had left. Surgeons called product managers directly, and I spent more time in theatres than at my desk. The work was practical: reducing instrument variants, answering sizing questions, rewriting technique guides and supporting the clinical studies our medical affairs team ran. I also learnt how Belgian and French hospitals bought implants, and how far a tender could turn on instruments, training and service rather than price alone. I had three product specialists and reported to the marketing director. The counts I organised with hospital sterile-services teams showed that seven instrument variants were almost never used, and removing them was my first lesson in persuading surgeons to accept less choice. When the knee portfolio needed one owner, I was asked to take it.

Reason for the move

Asked to take the whole knee portfolio after arguing for fewer options rather than more.

Mandate

Manage a cementless hip range, its instruments and its surgical technique across Italy and export markets.

Outcomes

• Added two stem variants requested by advising surgeons
• Removed four rarely used sizes with a documented transition for hospitals
• Produced the range's first surgeon-education programme for export distributors

Decisions in context

Valtorsa gave me my first responsibility for a complete implant system. I managed a cementless hip range, its instruments and its surgical technique, working with engineers, the surgeons who advised the company and sales teams in Italy and export markets. I learnt the weight of an orthopaedic product's history: surgeons wanted registry results and long-term follow-up, not brochures. I also saw how quickly a range grows when each important customer asks for one more size or option. Over five years we added two stem variants and removed four rarely used sizes, which taught me that removal needs as much evidence and explanation as a launch. I reported to the marketing director and had two product specialists. I left when Merlicourt offered responsibility for knees, a larger market, in a company where product decisions were taken close to the surgeons using them.

Reason for the move

Recruited by Merlicourt to manage knee systems in a larger market.

Mandate

Design and verify cutting guides, impactors and trial components to the company's quality procedures.

Outcomes

• Redesigned a tibial cutting guide after theatre trials
• Reduced parts in a reusable impactor from eleven to seven
• Prepared verification test plans with the quality team

Decisions in context

My first job was in a twelve-person design office making instruments for orthopaedic and spinal surgery. I designed and tested cutting guides, impactors and trial components, prepared drawings and tolerance analyses and supported the verification testing our quality team required. The most useful hours were spent in demonstration theatres and hospital sterile-services departments. A guide that met every dimension could still fight a surgeon's hand, and an instrument that was hard to dismantle cost a nurse time after every case. I had no direct reports and worked under the engineering manager. By 2003 I wanted to understand how an instrument fitted into a whole implant system and the evidence behind it, which a design office could not teach me. A product role at an implant company in Turin, near my mother's family, made that possible, and I took it.

Reason for the move

Moved to an implant manufacturer to learn how instruments fit a complete system and its evidence.