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.

### LISTEN NOW:

### 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.

### Links:

[Sonavex](https://www.sonavex.com/)

[News -Sonavex](https://www.sonavex.com/news/)

[FDA - Medical Devices](https://www.fda.gov/MEDICALDEVICES/DEFAULT.HTM)

[510(k) Premarket Submission](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm)

[Final Guidance on “Use of International Standard ISO 10993-1, Biological evaluation of medical devices](https://www.fda.gov/medicaldevices/newsevents/workshopsconferences/ucm507235.htm)

[Mike](https://www.linkedin.com/in/michaeldrues)

[Drues of Vascular Sciences](https://www.linkedin.com/in/michaeldrues)

[TMCx](https://www.tmc.edu/innovation/innovation-programs/tmcx/)

[Crunchbase](https://www.crunchbase.com/)

[Ronny Bracken](https://www.linkedin.com/in/ronald-bracken-75b83837)

[Global Medical Device Podcast](/content/podcast/index.html)

[Greenlight Guru](/content/site-root.html)

### 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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### ABOUT MEDTECH TRUE QUALITY STORIES PODCAST

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MedTech True Quality Stories Podcast, powered by[Greenlight Guru](/content/site-root.html), 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.