To avoid common design decision pitfalls and safeguard your medical device’s usability, read this whitepaper. You’ll learn how to prevent the four biggest missteps in the first place and see how MindFlow Design’s process is structured to help you even further.
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.
If you’re reading this, you probably have a viable idea for a new medical device — and that’s exciting. You’re ready to launch a startup and get your product into the hands of the users who need it most.
But beware. Bringing a medical device to market is a years-long process full of complex regulatory hurdles and business decisions — considerations most product inventors (doctors and scientists, namely) aren’t accustomed to making. Add to that the desire to found a sustainable startup and you’re really facing an uphill battle.
The good news? There are some prescribed steps you can take — that many startups often overlook — to ensure you’re on the right track.
Medical device development is full of regulatory hoops and documentation. Unfortunately, it’s all too easy to view some of the requirements as little more than “paperwork.”
The use specification document is a prime example. Composed of just a handful of short questions, the use specification document asks for basic details about your medical device: what it is intended to treat, how it functions, who will use it, and in what environment.
If you want to defend and grow your medical device brand's position in the market over the long haul, you need to compete on more than just your technology. You need a top-notch user experience to maintain your competitive advantage.
Original equipment manufacturers (OEMs) and contract manufacturers play an important role in the medical device industry. Whether they produce their own proprietary components or build entire products to spec, their services are critical to the medical device production process.
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.