How do medical device companies approach the “scaries” related to quality and guidance regulations without breaking the bank?
Today’s guest is David Narrow, CEO and founder of Sonavex, a medical device company that offers automated ultrasound solutions. David played a key role in helping Sonavex grow by going from a startup to developing an idea to launching a product in just three years.
David shares how to successfully fundraise for seed and Series A rounds, implement a quality management system (QMS), and achieve regulatory pre-submission and 510(k) clearance.
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Some of the highlights of the show include:
- Cost-effective and efficient options: Bring in somebody to set up paper-based QMS or select electronic QMS with expert guidance on implementation and maintenance procedures.
- Sonavex sought buy-in from FDA early on and put together a thorough pre-submission package to gain confidence and move forward with its product.
- Pre-submission process is a time-intensive but worthwhile paperwork burden. The information gathered is imperative and prepares you for 510(k) submission.
- Once on the 510(k) path, you’re usually committed to various activities, including expensive verification testing. Pre-submission can prevent need for re-testing.
- Sonavex and TMCx strive to understand reimbursement, healthcare economics, and other key facets. Do good and help each other through resources.
- David’s Advice: Identify what you don’t know, get support from resources/experts, obtain experience, take calculated risks, etc.
- When fundraising, figure out and find an investor who is the right fit based on the purpose and stage of your company.
- David describes what to look forward to at Sonavex, such as starting a limited release of its first product and pursuing initial market applications.
FDA - Medical Devices
510(k) Premarket Submission
Final Guidance on “Use of International Standard ISO 10993-1, Biological evaluation of medical devices
Mike Drues of Vascular Sciences
Global Medical Device Podcast
Quotes by David Narrow:
“An (electronic) quality management system...has the added benefit of people who were experts that could guide us through the implementation and maintenance procedures.”
“We got the advice early on to get some buy-in from FDA as soon as we could. We went out of our way to put together a very thorough pre-submission package.”
“Starting a conversation early vs. preparing a big regulatory submission and crossing your fingers and hoping for the best.”
“As long as you know that it’s going to take that time and you start early, it was absolutely worth it and puts you in a great position for success.”
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MedTech True Quality Stories Podcast, powered by Greenlight Guru, takes listeners on a storytelling journey through personal narratives of MedTech executives who offer real-world, actionable advice to industry leaders for guidance towards future imagination, implementation, and innovation of True Quality medical devices.
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