Tiffany Wilson, CEO of The Global Center for Medical Innovation (GCMI), and Frank Tighe, Lead Entrepreneur in Residence at The Advanced Technology Development Center (ATDC), discussed the medical product development process for early stage innovators. Learn from their experiences by watching.
Too many promising medtech innovations and early stage companies fail unnecessarily because they run out of funding before achieving milestones required for next-round investments.
What do medtech innovators need to know about the stringent particulars including documentation, registration, design control, quality systems, validation, regulatory, investment or exit requirements for medtech innovation? How important is process sequencing and adherence to it?
For example, seemingly innocuous changes or enhancements to a product have cascading effects that may move your 510(k) project to a PMA regulatory requirement that includes clinical trials without your knowledge until years later if you don’t have the right team in place at the right time.
We thank Frank and ATDC for their insights and partnership in our quest to successfully guide medtech innovation.
The GCMI team works with medtech innovators to realize products 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.
“We built this team to help others avoid the challenges I faced during my 10 year startup run. We approach everything from a standpoint of intense focus on quality and service. Everyone on our team is here to make a difference.” – Tiffany Wilson
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