Clinical Data and Medical Device: What If Your Internal Data Were an Untapped Clinical Resource?

Do you recognise this situation?

Your medical device has been on the market for several years. You have data — complaints, vigilance data, perhaps marketing studies or user panels — but their potential as clinical data has never been formally assessed.

The question of clinical strategy is not always straightforward: requirements evolve, notified body expectations do too, and it is not always clear whether the available data is sufficient, whether new investigations are needed, or how to combine existing and new data to meet regulatory requirements while supporting product claims and positioning with prescribers.

Because this is a point that is sometimes overlooked: a well-built clinical strategy does not only serve to meet regulatory requirements. It also makes it possible to demonstrate the clinical value of the product, differentiate it from the competition and support its place in the therapeutic landscape — arguments that clinical studies, when well designed, are the only ones capable of providing convincingly. The challenge is then to find the most relevant approach at the best cost by leveraging what already exists first.

What was at stake

The absence of a formalised clinical strategy and well-organised clinical data has concrete consequences on several fronts:

• On clinical evaluation. Without post-market data collected and formalised, the benefit-risk ratio is difficult to argue. Clinical evaluation conclusions lack robustness, and the links with risk management and post-market surveillance data are not established.
• On PMCF. Post-market clinical follow-up plans and reports are difficult to build without clearly identified input data. The activities to be implemented, the internal stakeholders involved and the modalities of implementation remain unclear.
• On missed opportunities. Valuable data often exists within the company without anyone realising it: complaints, vigilance data, marketing study results, user panels. These assets, properly leveraged, can directly feed the clinical strategy and significantly reduce the cost of generating new data.

This is a frequent situation and one that affects device manufacturers of all classes, including those marketing Class I medical devices for whom the post-market clinical dimension has not always been integrated from the earliest stages of the project.

What was done

I supported a medical device manufacturer in remediating its clinical data generation strategy and formalising its PMCF activities in collaboration with LyREC, a specialist partner in the strategy and conduct of clinical investigations, with recognised expertise in regulatory submissions and the design of studies adapted to the constraints and resources of each project. The mission was carried out in four steps:

• Step 1: Identifying clinical data generation scenarios
  Starting from the data already collected by the company — complaints, vigilance data, marketing studies — we analysed their potential for use as clinical data: retrospective studies, real-world data, prospective approaches using existing user panels. Each scenario was evaluated according to its compliance / cost / ease of implementation balance.
• Step 2: Selecting methods and producing initial documents
  Based on the most promising scenarios, we produced a first draft of the clinical data and PMCF documents including reformatting of existing data, draft protocols and reports, and a methodological guide for the internal teams.
• Step 3: Clinical review and compliance
  The documents were reviewed from a clinical and statistical standpoint by LyREC, to ensure compliance with applicable good clinical and statistical practice.
• Step 4: Implementation
  The finalised protocols, reports and methodological guide were submitted to the company for integration with update of PMCF plans and applicable procedures.

What changed

The company had a clear methodology for generating and leveraging its clinical data building on its existing assets rather than starting from scratch. PMCF activities were formalised, internal stakeholders identified, and documents ready to be integrated into the regulatory file. And beyond compliance, the company had the foundations to build a solid clinical dialogue with its prescribers.

→ Are you marketing a medical device and wondering about the clinical potential of your internal data? A One Health Compliance Project Audit, conducted in collaboration with LyREC, allows you to identify your clinical assets, define the most relevant leverage scenarios and build a realistic action plan to strengthen your file and your clinical positioning without starting from scratch.

Sandra Dejean, PharmD –  Founder of One Health Compliance

© One Health Compliance