To Build or Not To Build: The CLIA Lab Dilemma for Startups

BioStrategy Partners May 2025 Practical Knowledge Series

Location: Center for Diagnostic Discovery (206 Welsh Rd. Horsham, PA 19044)

For entrepreneurs developing diagnostics, the decision to build an in-house CLIA-certified lab-or to partner with existing labs–can define the trajectory of the business. Our expert panelists will demystify the complexities of the Clinical Laboratory Improvement Amendments (CLIA) framework and explore how it intersects with regulatory pathways for medical devices, diagnostics, and lab-developed tests (LDTs). We will dive into strategies for regulatory pathways, reimbursement, and how to operationalize your own CLIA-lab vs. how best to outsource your commercial development. With real-world insights from seasoned lab executives and regulatory experts, this panel will provide you with a clear pathway to appropriately classify your product, reach your target market, and decide whether to build, buy, or partner

3:30pm-4:00pm – Registration
4:00pm-5:00pm – Panel
5:00pm-6:00pm – Tour & Networking

Moderator:
Alexandra Smythe, Director of Regulatory Affairs, IDE Group

Speakers:
Robert Middleberg PhD, Core Laboratory Director, NMS Labs
Martin Till, President & CEO, HNL Lab Medicine
Robert Boorstein, MD, PhD, Founder & Director, ClasGroup LLC.