In this episode of She Leads Biotech, I’m joined by Kristen Mittal, Co-founder & CEO of Mittal Consulting, a firm that’s quietly become one of the go-to regulatory partners for early-stage medtech startups across the U.S.
Kristen’s background as a biomedical engineer, combined with her deep understanding of regulatory and commercialization strategy, gives her a unique lens into what founders really need, especially in today’s tighter funding and approval climate.
We talk about:
🔹 How she built Mittal Consulting from a solo operation to a 20+ person team
🔹 Why most founders overlook regulatory until it’s too late
🔹 Her philosophy on aligning regulatory pathways with reimbursement strategy
🔹 The surprising truth about working with your spouse — and how they grew the business together
🔹 Her work with MedTech Women and why more women need to be in boardrooms
“If your product is regulatory-ready but not commercially viable, that’s not a win. Founders need better guidance earlier.”
📌 Chapters / Timestamps:
00:00 – Meet Kristen and the origin of Mittal Consulting
03:15 – The evolution from engineer to regulatory strategist
06:30 – Common mistakes founders make in FDA planning
10:00 – When to bring in regulatory expertise (spoiler: it’s early)
13:30 – Building a company with your husband (and staying sane)
16:00 – Hiring, culture, and growing during the pandemic
20:00 – Why FDA approval isn’t the final hurdle — reimbursement is
23:00 – MedTech Women, visibility, and equity in board leadership
26:00 – Advice to early-stage founders and regulatory professionals
Tune in to hear how Kristen is helping the next wave of medtech innovators build smart, from day one.
#SheLeadsBiotech #KristenMittal #MittalConsulting #MedTech #RegulatoryStrategy #WomenInSTEM #BoardRepresentation #Startups #BiotechLeadership #CNAInternationalUSA
