How to Design a Clinical Development Pathway for a Medical Device

Clinical validation is a key step during the development of medical technologies. In pharma there are clearly defined pathways, however such pathways for validation of medical devices are less clear and must be uniquely considered for each product. A specific question that requires consideration is the determination of clinical endpoints. If this isn’t correctly defined, it could critically impact your business and its timeline. We believe this decision-making process goes hand in hand with market and stakeholder validation.

Defining your clinical endpoint

When defining your clinical endpoint, it is common to focus on the obvious first user of your clinical information; the regulator. This is often informed by the advice from a few key opinion leaders and a statistician. However, if you wish to build a successful business, you must consider all long-term stakeholders. This includes reimbursors, hospital managers, prescribing medical professionals and their professional organisation, end users/patients, and commercial partners/acquirers. Additionally, one must consider which market segments or clinical conditions to initially target. Planning to do only the minimum required for regulatory approval only sets up for commercial disappointment. This makes development of medical devices complex.

Conversely, an equally important challenge is focus. If a company attempted to design a single study that satisfied all these parties, it may be unachievable. The first study must have a relevant and meaningful endpoint that advances the development to the next stage, while being realistic to achieve with current resources. There is no point in shooting for the moon with a study that is perfectly designed, but not feasible. Often there is an opportunity to achieve meaningful first steps with a more modest study, while holding a clearly defined plan for future work. This is the case with any R&D program, medical or otherwise. 

Bigger is not always better

As an example, we recently advised a medical device company that set an ambitious clinical endpoint that it thought stakeholders wished to see. The company soon realised that to demonstrate this endpoint using a locally available patient population, it would require a study exceeding 50,000 individuals. When the company communicated with its key customer and the initial market regulator, it found that they expected a clinical study to demonstrate a simpler endpoint that could be validated by an initial study of 150 patients. This difference was critical. The initial plan was not feasible for an organisation with limited funding, and with the available patient population and time. 

The story above highlights the value of communicating with key stakeholders to determine, in advance, their data requirements when developing your clinical endpoints. If these criteria are unclear, then you could be designing a clinical study that takes you down a long and expensive pathway, or conversely setting yourself up for regulatory success but commercial failure. By defining the requirements of your stakeholders, you are ensuring that your product is well placed to address their needs and should be able to seamlessly move through the clinical development process, gain regulatory approval and subsequently market traction.  

The importance of connecting early

In every step of medical device development, communication with your stakeholders is key to your success. Make sure you connect early to ensure that you set strong foundations to build upon. These conversations with your stakeholders are likely to have a major effect on not only your clinical validation, but also your understanding of the market requirements and therefore your funding requirements.