Medtech innovation is an exciting, yet risky enterprise. The vast majority of venture capital and strategic investors now want to see early investment in de-risking medical innovations. There is simply too much potential for failure in the pathway to commercialization, plus financial risk related to market forces and competitive products.


Too many medtech development projects are unsuccessful because innovators discover major roadblocks too late in the process. Here are some of the top ways to give your medtech innovation a better chance for successful commercialization.


Define the development scope and appropriate budget.

Medtech innovators, especially early stage companies, run out of money because they fail to anticipate the volume of work to get to commercialization. Activities and costs can add up on everything from prototyping to preclinical testing to experts like IP consultants. Establish and fund a robust budget for your innovative medical technologies.


Can the technology pass required testing?

If a product fails to pass required testing like software validation, reliability or shipping simulation, the efforts to re-design, re-manufacture and re-test can be anywhere from cumbersome to catastrophic. Ideally, those performance risks should be uncovered during earlier phases of product development. The earlier they’re caught, the easier they are to address. In an extreme example: a product in a clinical trial contributes to a patient fatality; the company may not have the funds and market support to continue.  


Related – Salvage and spike it: what to do when your GLP preclinical study raises questions


Use qualified vendors and suppliers.

All project vendors, from design firms to packaging suppliers, are critical links in a medical product’s success. Assembly manufacturers that do not sufficiently qualify their processes, design teams that do not work within appropriate quality systems, material suppliers that change their formulations without notice – all of these add risks of having to repeat or add work to the project. The later those risks pop up, the more devastating. A medical product might make it through regulatory approval, but then hit huge costs when increasing production volumes if assembly steps haven’t been or can’t be validated.

This is certainly not a comprehensive list. There are manufacturability, IP, documentation and other requirements that can sabotage high potential products. Contact us through the form below to get the conversation started.


Why choose GCMI as your medtech innovation partner?

The GCMI team works with you to realize your product while considering regulatory compliance, clinical practices, intellectual property, and healthcare economics. GCMI has the holistic medtech innovation experience required to support a successful regulatory submission, and ultimately, commercialization. Our design and development team contributes development expertise, clinical insights, medical device design skills, project management, and an ecosystem of experts to minimize risks in a disciplined, phase-gated process.