You’ve had a brilliant idea that will improve the lives of others. You’re caught up in the excitement of your invention and the possibilities of the future. You’re eager to get into development and dream of the day your functional medical device is in the hands of the intended users.
It might be strange for inventors and entrepreneurs, but it is at this early stage that careful thought needs to go into what “the end” looks like and how to achieve this. “The end” could be a huge industry founded from the success of this first product, or it could be a trade sale of the invention. Both outcomes are hard to achieve without planning.
There is a big difference between thinking about the end goal and being captured by it. Thinking about it means considering the implications for achieving the planned end goal. This includes consideration of questions such as:
- Are similar devices already being sold?
- Which regulatory markets are the similar devices available in?
- What does the patent and other IP look like?
- What sort of companies buy your sort of innovation?
- At what stage of the development do they do buy these innovations?
- What stage is the reimbursement strategy?
The medical device industry is peppered with possible speed bumps and road blocks which can be fatal for a startup. Consideration of the “end point” allows you the best chance of success. The pathway to the endpoint naturally lead to questions about the regulatory requirements needed for your innovation and the Quality Management System needed to underpin these requirements. The considerations should also lead you to consider the health economics of your innovation (What will it cost? What money will it save? Who is going to pay?) as well as some thought about the competitors you mean to displace and the collaborators you will need along the way.
While this may seem premature when all you have is an idea, and perhaps a provisional patent, the very beginning of a project is the right time to think about these issues so that you start the process of building them into your overall project plan.
At the discovery stage of an innovation, it might also seem strange to think about regulatory requirements, but these can reach all the way down to subtle design changes which might make the pathway through CE Marking (EU) and FDA Clearance (USA) much easier. The design changes are easy to make on day one, very hard to make closer to the end of the development.
Similarly, consideration of the health economics of your innovation and the sensitivities of the various “payers” can better inform your design choices, clinical claims, and route to market. You don’t need to do a huge study at this early phase, but some limited early exploration of this space will potentially deliver huge dividends in terms of reduced time, reduced expense, and a greater likelihood of success.
Managing these often conflicting demands on a project is what we do at Vestech Medical. We do it with the benefit of our own decades of experience in bringing products to market.
Not all companies have a deep understanding of regulatory and quality management strategies that integrate seamlessly into our proven project management template. Vestech Medical will partner with you, as needed, all the way from the beginning to the end, both locally and abroad.
- On 20 January 2023