🟦Built to Win: Aligning Innovation, Regulation, and Patient Needs in MedTech

Description

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Every month, brilliant healthcare innovations die in regulatory purgatory while patients wait for solutions that never come. The statistics are brutal: 75-90% of medtech startups fail despite raising millions in funding. The average medical device takes 5.2 years and $31 million to reach market, with $24 million of that spent navigating FDA requirements that could have been anticipated from day one.

But here's what's even more heartbreaking: the "successful" products that do make it through often sit unused in hospitals because no one asked the patients what they actually needed.

You didn't start your company to become another failure statistic. You have a vision for transforming patient care. The question is: will you build to win, or build to fail?

What You'll Gain:

• Insider Health System Evaluation Criteria: Learn the exact framework health systems use to select innovation partners (most founders never see this)
• Patient Validation Without HIPAA Headaches: Access diverse patient insights through AI-powered Listen Phirst platform that handle compliance automatically
• Regulatory Risk Reduction: Identify FDA pathway obstacles before they derail your timeline and budget
• Investor De-Risking Tools: Frameworks that help investors evaluate medtech opportunities with greater confidence

The Build to Win Advantage: Companies using structured patient engagement achieve 95%+ pilot conversion rates and secure funding 3.6 months faster than average. This isn't about generic advice—it's about the insider knowledge that separates winners from casualties.

Your Registration Options

Part 1: Main Session

Time: Wednesday, October 22nd, 2025, 12– 1PM ET
Access: Free (Open to all registrants)
Format: Live Interactive Webinar
Details:

• Why 90% of brilliant medtech innovations fail (and it's not what you think)
• The regulatory pathway optimization that saves years and millions
• Expert-led deep dive into the SEEDS Innovation Framework to shape product-system fit
• Live demonstration of Listen Phirst™: AI-powered patient validation that handles compliance automatically

BONUS: First 50 registrants receive the Health System Readiness Checklist—the same framework health systems use to evaluate innovation partnerships. This tool alone could save you months of misdirected development.

At the end of the session, you’ll be given a pay-it-forward contribution option (even $1 helps support future events).

Part 2: VIP Deep Dive + Coaching

Time: Wednesday, October 22nd, 2025, 1– 2PM ET
Access: VIP Only (Limited to 3 Spots) - $149
Format: Live interactive webinar
Details:

• Exclusive group coaching session with Sheila Phicil and Janet Kwiatkowski
• Direct feedback on your specific medtech solution

All registrants receive main session access and replay. Upgrade to VIP at registration—only 3 coaching spots available.

Meet Your Expert Presenters

Sheila Phicil, MPH, MS, PMP, FACHE Creator of the SEEDS Innovation Framework | Former Health System Innovation Director

Sheila has the insider knowledge most consultants can only guess at. As former Director of Innovation for the Health Equity Accelerator at Boston Medical Center, she made the partnership decisions that startups were pitching for. She knows exactly what health systems look for—and what makes them say no.

Now as founder of Phicil-itate Change and creator of the Listen Phirst™ platform, she's bridging the gap between patient needs and innovation design. Her SEEDS Framework is used by accelerators, health systems, and founders to accelerate product-system fit by validating what patients actually need, not just what innovators think they need.

• Fellow of the American College of Healthcare Executives (FACHE)
• Nearly 20 years across Brigham and Women's, Dana-Farber, VA, and Boston Medical Center
• Dual master's degrees from Boston University
• 2022 Fellow of the Massachusetts Health Leadership College

Janet Kwiatkowski, ASEE, BSME, MBA, MS Regulatory Affairs President & CEO, MAE Group | Medtech Commercialization Expert

Janet doesn't just advise on regulatory strategy—she's living it. Currently shepherding her own device through FDA approval for brain cancer treatment, she combines 25+ years of consulting experience with real-world commercialization challenges happening right now.

Her MAE Group has helped dozens of medtech startups navigate the regulatory maze aligned with viable technology and investor triggers, with particular expertise in the startup-to-Series A journey where most failures occur. She knows the difference between regulatory advice that sounds good and strategies that actually work.

• Master of Science in Regulatory Affairs for Drugs, Biologics and Medical Devices
• 25+ years serving medtech and diagnostic device companies globally
• Currently bringing own medical device through FDA approval process
• Mechanical Engineer with MBA and international business expertise

Register Now - Limited Spots Available

Health systems are finalizing their 2026 innovation partnerships. The founders who understand product-system fit will win the partnerships others have been chasing for months.

Attend Live and Receive:

• Health System Readiness Assessment Tool (Value: $297)
• Exclusive invitation to be early beta pilot tester of Listen Phirst Platform
• Exclusive one hour deep dive regulatory strategy tailored to your device (Value: $400)*

* Requires prerequisite information prior to call

Can't Attend Live? All registrants receive the recording, but live attendees get first access to the bonus materials and can participate in the interactive Q&A that often generates the most valuable insights.

Questions? Email hello@phicil-itatechange.com