Upcoming events
Meet Allison and team at these upcoming medtech industry events!
Want to book Bluestocking Health to come talk at your school, organization, or event?
Women’s Health Innovation Summit
November 13, 2025 | Aggie Square, Sacramento, CA
What if policy could be the catalyst for women's health innovation instead of a barrier? 🔥
That's exactly what we're exploring November 13 at the Women's Health Innovation Summit in Sacramento. Amazing Bluestocking Health Advisor Nada Hanafi, MSc, MPH will be tackling "Policy as a Platform for Innovation" and "Data Equity" with leaders who understand that transforming care starts with getting the foundation right.
Better frameworks → Better data → Better outcomes for women.
Ready to reimagine what's possible?
Join us:
https://visitaggiesquare.com/womens-health-innovation-summit/
MedTech Strategist Innovation Summit San Diego 2025
Workshop
The Once and Future FDA: Positioning Your Start-Up for an Evolving Market Access Ecosystem
Wednesday, Nov. 19, 2025
9:00 a.m. - 9:40 a.m.
Speakers:
Marty Culjat, SVP, Global Head of Digital Medicine & Regulatory Innovation, Eversana
Allison Komiyama, CEO/Founder, Bluestocking Health
David Filmore, Executive Editor, Market Pathways (Moderator)
T1D Tech Moonshot: Spoonshot Automated Insulin Delivery (AID) & Software Velocity and Cybersecurity Solutions Workshop
Sponsored by Bluestocking Health
Thursday, Oct. 30, 2025 - 8:00 am - 4:30 pm PT
Google San Diego
Details
Today’s medical device software updates often take months, while cyber threats move in hours. The T1D Moonshot focuses on type 1 diabetes (T1D) AID systems as a proving ground to compress safe, compliant update cycles from months to days—without sacrificing safety, performance, or regulatory alignment.
Serious Talent® Chat: “Scary FDA Updates & Opportunities”
Serious Talent® Chat: “Scary FDA Updates & Opportunities”
Tuesday, Oct 28, 2025 - 11:00 am PT
Live on LinkedIn | Join here
Allison Komiyama
CEO & Founder, Bluestocking Health, LLC
Let’s bust some myths and share what’s really happening at FDA, with a healthy dose of nerdy fun. Hear directly from your peers regarding resources, approaches, expectations, and opportunities.
RAPS Convergence
Workshop
Survivor: The FDA 510(k) Program Edition
Monday-Tuesday, Oct. 6-7, 2025
8:30 a.m. - 4:00 pm
Room 315
Solutions Circles
Submission Gaps in Medical Devices in U.S. and How to Resolve Them
Session 1: Wednesday, Oct. 8, 2025
3:20 p.m. - 3:50 p.m.
Session 2: Thursday, Oct. 9, 2025
2:05 p.m. - 2:35 p.m.
Exhibit Hall: Circle A
The MedTech Conference
Panel Session: Navigating the FDA’s De Novo Program: Incorporating Best Practices from the Beginning
Monday, October 6, 2025 | 3:15–4:15 PM
Upper Level, Room 6C
Speakers:
Josh Silverstein
Director, Regulatory Science and Policy, Philips (Moderator)
Allison Komiyama, PhD, RAC
Consultant, Bluestocking Health
Joshua Nipper, ME
Director, Division of Regulatory Programs 1, U.S. Food and Drug Administration
Laura Yecies, MBA, MS
CEO, Osteoboost Health
Cody Simmons
CEO, DermaSensor Inc.
The De Novo Program is the regulatory pathway in the United States for innovative medical technologies that present low to moderate risk to patients. First established in 1997, the De Novo Program has evolved considerably in recent years and more manufacturers are using this pathway to bring novel devices to market. While the FDA continues to authorize numerous products through the De Novo Program, the innovative nature of products eligible for De Novo presents unique challenges for industry and the FDA because there is no established regulatory precedent for the product. To navigate through these challenges, successful FDA engagement and regulatory strategy can make the difference between marketing authorization and a negative decision.
This session will explore the current and potential future state of the De Novo Program, including identification of best practices and common pitfalls to improve engagement with the FDA in advance of and during the Agency’s review of a De Novo request. The panel will culminate in an interactive question-and-answer session, which will allow participants to ask questions to the panelists.
The MedTech Conference Event Website