Study synopses: Medical and economic background

Study synopses are crucial for manufacturers of innovative medical devices because it clearly defines the scientific basis for clinical studies, meets regulatory requirements, creates trust among service providers and patients, and significantly supports the targeted positioning and market success of the product.

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There are different approaches for professionals to write the optimal scientific study synopsis for manufacturers and their products. The basis must first and foremost be the product for which the subsequent study will take place. However, there are then different approaches to how the strategic orientation takes place, which is then written down in the synopsis. These approaches are the scientific-clinical, the market-oriented, the regulatory-strategic approach, or a hybrid of these.

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Specialist expertise: focus on evidence-based medicine

Scientific-clinical approaches focus on demonstrating medical added value compared to existing solutions. This approach takes into account the development of a solution based on the expertise of doctors, physiotherapists, nursing staff and other actors involved in everyday life with a high level of expertise. The aim is to critically review the medical evidence for new therapies and procedures and to develop practice-relevant recommendations. They are used to improve the quality of care, optimize treatment algorithms and evaluate the safety and effectiveness of new medical approaches. Even if the market reached does not have to be very large, relevant solutions are developed and evidence is generated that directly solves an existing problem for those affected.

Market analyses: Identifying economic opportunities

The market-oriented approach focuses more on the regulated healthcare market as a whole and is based on economic indicators with the aim of maximum market penetration, from which a novel solution for the regulated healthcare market is developed. Cost savings compared to existing diagnostic or treatment options often play a role here. Tailored business models can be developed in the process. In order to achieve the desired goal, it is absolutely necessary to reconcile the needs and associated characteristics of the regulated healthcare market in the course of the process. This approach makes it possible to reach as large a market as possible.

Regulatory-strategic: When risks are controlled to the maximum

Some approaches should focus on strategic and regulatory requirements (e.g. MDR, FDA). The focus is therefore on specifically addressing the criteria and evidence relevant for approval in order to minimize hurdles in the approval process and speed up the path to market launch. This also includes the targeted selection of endpoints and study populations that ensure regulatory acceptance. Since public authorities usually have little leeway within which they can make compromises, weighting this approach may be essential in these cases.

Different approaches, common goal

It takes many years of experience and expertise with a view to all three approaches to develop the best strategic solution for them based on the wishes of innovators. The best evidence from the most complex study should definitely keep in mind that the investments will later have to be reimbursed by the market and that the product is actually needed. This approach ensures that our patients — who are not and should not become customers — are well protected and that illnesses can be cured or alleviated.

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Would you like such an approach for your innovative medical device? Feel free to contact us for a first non-binding consultation!

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