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Episode 1  |  27:11 min

How Sonavex Went from Concept to FDA Clearance in Just 3 Years

Episode 1  |  27:11 min  |  04.07.2019

How Sonavex Went from Concept to FDA Clearance in Just 3 Years

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This is a podcast episode titled, How Sonavex Went from Concept to FDA Clearance in Just 3 Years. The summary for this episode is: 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. 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.
Takeaway 1 | 00:19 MIN
Experienced Professionals Guide Implementation of eQMS
Takeaway 2 | 00:34 MIN
Great QMS Vendor Relationship Gives Companies a Competitive Edge
Takeaway 3 | 00:45 MIN
Key Elements of a Company's Success