About Pacific Medtech Oversight

I’m Vivek Balasubramanyam, founder of Pacific Medtech Oversight. I work with medtech companies that rely on external vendors to deliver critical pieces of R&D, regulatory, manufacturing, or commercial programs. These projects often involve multiple teams, each moving quickly and making decisions under pressure. What puts them at risk isn’t a lack of expertise; it’s low-level decisions made with missing, misinterpreted, or forgotten information.

That’s where I come in. I offer fractional executive oversight: I embed with your team to watch for the places where context is getting lost, assumptions are diverging, or requirements aren’t being followed the way you think they are. Sometimes that means stepping in before things go sideways. Sometimes it means recognizing what’s already gone a little off track and correcting it before it turns into something costly or irreversible.

Executive oversight, in this case, isn’t about micromanagement. It’s about having someone who sees the full picture, understands the connections between technical progress, regulatory risk, and commercial outcomes, and takes responsibility for keeping those moving parts aligned. Whether I’m monitoring design and development, supporting V&V and regulatory filings, or helping launch plans stay grounded in reality, I help teams make better decisions, faster, and with fewer surprises.

Experience

  • 20+ years in medtech and diagnostics

  • Senior roles at Abbott, Pfizer, Lucira Health, CAIRE Diagnostics

  • Experience in product development, regulatory strategy, and commercialization

  • Deep familiarity with ISO 13485, ISO 62307, ISO 14971, 510(k), and IVDR

  • Based in British Columbia, working remotely with and traveling to teams across Canada, the US, and Europe

Who I Work With

I work with Seed and Series A medtech companies that are tackling complex projects with limited internal capacity. They often have strong partners and vendors in place, but need someone to keep expectations, timelines, and technical realities aligned across the board. In many cases, the leadership team brings deep expertise in certain areas but knows there are gaps. That’s where I come in. I bring broad-based medtech experience to fill in the edges and let you stay focused on what you do best.