Each of these 3 stages is important — and has its experts. The middle stage, developing the core technology, involves proving the science is feasible before investing substantial resources on the path to commercialization. This vital process ensures you don’t waste time and money on an unfeasible medical device.
Risk management is a crucial aspect of medical device development. You need to account for and mitigate the risks associated with your product early on, so it’s safe for users and passes increasingly stringent FDA requirements.
It’s a consequential decision to hand over the responsibility of designing your medical device to an outside team — even if it’s only for part of the project. You need to have a lot of trust and confidence in the firm you hire.
Of course, you’ve been feeling the landscape shift for years. That’s why you’re already so concerned about time to market and first mover advantage. The problem is that your medical device development process has to change if you want to be as fast (and high quality) as the market now demands.
Creating a comprehensive traceability matrix hinges on sourcing accurate user, safety, science, and technology needs related to your medical device. Like most companies, your firm is probably science-and/or technology-driven. You’re comfortable documenting these needs in your matrix. But user and safety needs? You have a harder time figuring out where to look for those.
New medical devices offer fresh opportunities for your company to improve health outcomes, push the boundaries of medical innovation, and grow your business. Who wouldn’t be excited about that? But these devices also carry varying levels of risk that must be carefully managed.
No matter what stage of development your medical product is in, Mindflow can help.
MindFlow Design is a leading medical product development firm for Medical, Life Sciences, and Consumer Health Companies and is based in Carlsbad, CA. We aspire to introduce powerful, intuitive healthcare technologies to the world.