Medical Device Company

Before anything else could work, the business needed structure — clear accountability, consistent cadence, and visibility into where things stood at every stage of the FDA process.

• Structured and led quarterly board meetings and monthly leadership meetings throughout the engagement, later adding weekly operations meetings to maintain accountability and track regulatory progress through each stage.
• Created the operational discipline that kept the team focused and aligned during a multi-year approval process with no commercial revenue to anchor priorities.

Keeping a pre-revenue medical device company funded through an extended regulatory timeline required disciplined capital stewardship and continuous investor alignment.

• Drove multiple recapitalization rounds over the course of the engagement, including valuation support, pricing and structuring of investment terms, and direct coordination with legal counsel throughout each raise.
• Made careful tradeoffs around equipment purchases, outside vendors, resource allocation, and operating expenses to preserve capital while keeping the approval program on track.
• Maintained consistent investor communication throughout — providing regular updates on testing progress, regulatory milestones, and timeline shifts to sustain confidence and alignment during a process that stretched across years.

Once FDA 510(k) approval was achieved, the focus shifted to building the commercial foundation and positioning the company for a strategic transaction.

• Built a market entry plan in partnership with outside consultants to define the commercial launch strategy following approval.
• Created investor-grade acquisition materials and a pitch deck used to initiate and support discussions with strategic acquirers.
• Managed diligence requests and information flow directly, ensuring the company was fully prepared operationally, financially, and strategically for a potential transaction.