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.