Medical Device Playbook
Newport Beach 2025
Scaling & Selling in MedTech’s New Regulatory Reality
By Invitation Only – May 22, 2025 – Newport Beach, California
Medical Device Playbook returns to California, reimagined as an exclusive, invitation-only event that brings together some of the most visionary minds in MedTech—founders, investors, and executives who are actively shaping the industry’s future. This curated experience fosters candid discussions, real-world lessons, and practical strategies for overcoming challenges in today’s evolving regulatory and market landscape.
This year, Playbook delves into scaling and exiting MedTech companies in a shifting regulatory and market landscape. With Project 2025 poised to reshape the industry, speakers will share firsthand experiences on securing investment, navigating acquisitions, and positioning for long-term growth while adapting to changing regulations and market forces.
Why Attend
Medical Device Playbook is designed for leaders who want to move beyond theory and into action. This is not a traditional conference—this is where real conversations happen.
- Visionary Entrepreneurs & Experts: Hear directly from some of MedTech’s most remarkable entrepreneurs and seasoned experts who have navigated pivotal decisions, tough negotiations, and market shifts.
- Insights That Change Trajectories: Learn from deeply personal and impactful stories that reveal what truly drives success—and failure—in MedTech scaling and M&A.
- A Curated Audience: Every attendee has been carefully selected, ensuring meaningful discussions with like-minded leaders who share your challenges and ambitions.
- Confidential Conversations: Private, closed-door discussions where real experiences—not just polished success stories—are shared.
What to Expect
Unlike large-scale industry events, Medical Device Playbook is intentionally small—a space designed for candid conversations and direct access to the people you want to meet.
- Founder Spotlights & Keynotes: Gain unfiltered insights from MedTech entrepreneurs who have built, scaled, and exited companies.
- Investor & Acquirer Perspectives: Understand what top investors and acquiring companies look for in successful startups.
- Practical Strategies for Growth: Learn how to navigate regulatory challenges, commercialization hurdles, and financing opportunities.
- Private Executive Networking: Build relationships in an environment where meaningful connections come naturally.
With regulatory shifts on the horizon, speakers will also reflect on how past successes and challenges inform today’s MedTech realities—helping you make decisions that will define your company’s trajectory.
Sponsorship Opportunities for Medical Device Playbook Newport Beach 2025
Who is Invited?
Medical Device Playbook is not open to the public. Attendance is by invitation only for individuals who meet our selective criteria:
- Founders & CEOs of MedTech startups focused on bringing products to market
- Investors & venture capitalists actively funding medical technology
- Executives from leading MedTech companies and acquiring firms
- Thought leaders & experts shaping the future of healthcare innovation
“I travel all over the world and this conference was truly one of the most educational.”
Manny Villafaña, Founder of St. Jude Medical
Event Details
Location: VEA Newport Beach, A Marriott Resort & Spa
Date: May 22, 2025, 8:30am-6:00pm
Attendance: By Invitation Only
Presented by
Co-host
Sponsor
Supporting
Sponsor
For more information, please contact StarFish Medical Marketing.
Sessions
Partnering with Purpose: Working with the Gates Foundation
At GH Labs, global impact starts with practical solutions that work. Steve Kern shares how GH Labs evaluates new technologies, selects partners, and approaches global health innovation. You’ll get an inside look at how one of the world’s most influential organizations thinks about risk, evidence, and scale—and what that means for medtech companies looking to work with them.
Ready, Fire, Aim
Good research saves bad ideas before they cost millions. After 25 years in design research, Eric Olson has seen it all—rushed launches, overlooked users, and misread markets. He’ll walk through a case where deep research collapsed five instruments into one—and lit up sales. Come for the war stories, stay for the playbook.
Eric Olson
Breaking In
What happens when your breakthrough tech challenges an entire industry? CL Tian, CEO of Phiex, is taking on the $6B EtO sterilization market with a safer, faster alternative—and getting traction where others failed. She’ll share the missteps, pushback, and pivots behind her startup’s rise, and what it takes to win in a slow-moving, high-stakes space.
Inside the FDA Shift
The agency is in flux. What’s your move? With layoffs, backlogs, and new dynamics, the FDA is changing how it engages with startups. Regulatory strategist Tonya Porter explains what’s really happening—and what founders must do to avoid getting blindsided. It’s not business as usual.
Inside the Buyer’s Brain
What makes a startup irresistible to a $1B acquirer? Karthik Ranganathan runs M&A from the other side of the table. He’ll share how strategic buyers evaluate deals, pitch them internally, and weigh early vs. late-stage bets. Three real acquisitions. Three different stages. Real talk on what closed the deals—and what didn’t.
What Investors Want Now – VC Panel
Medtech investing just hit a plot twist. Fund cycles are shifting. Risk profiles are tightening. VCs are moving the goalposts—and not all startups are keeping up. This candid panel of top investors cuts through the noise: what’s changed, what still works, and how to stand out in 2025.
Speaker Bios
Steve Kern
Steven E. Kern, PhD is the Executive Director of Global Health Labs, an innovation laboratory based in Bellevue, Washington working in partnership with the Bill and Melinda Gates Foundation. From 20013-2022, he was the Deputy Director of Quantitative Sciences at the Gates Foundation. Prior to joining the Gates Foundation, he was Global Head of Pharmacology Modeling at Novartis Pharma AG based in Basel Switzerland where he led a team focused on providing model based drug development support to therapeutics in many disease conditions across all stages of drug development. He joined Novartis in 2010 from the University of Utah in Salt Lake City, Utah where he was Associate Professor of Pharmaceutics, Anesthesiology, and Bioengineering, and served as co-investigator for their NIH funded Pediatric Pharmacology Research Unit.
CL Tian
CL Tian is the CEO and Co-Founder of Phiex Technologies, a self-sterilizing materials platform which replaces ethylene oxide, the cancer-causing status quo gas used in medical device manufacturing, and sterilize in-line, without capital equipment. Phiex is the Global Winner of the ‘22 Medtech Innovator competition, placing #1 out of over 1000 medical technology companies globally as voted by industry leaders. She previously founded a firm specialized in business development as a service in diverse industries such as healthcare, SaaS, and B2B services. Committed to paying it forward, CL has served as a Mastermind at Babson College’s WIN Lab and President of the Boston Chapter of ACE NextGen, the Asian chamber of commerce for the next generation of entrepreneurs. CL graduated magna cum laude from Wellesley College and speaks Mandarin, Japanese, and Korean.
Tonya Porter
Tonya Porter, MS has a diverse background in the medical device industry, spanning product development to managing international clinical trials. Ms. Porter is independent consultant specializing in regulatory affairs, quality assurance, and clinical affairs for medical device companies. Prior to consulting, Ms. Porter was a member of the regulatory team at ReVision Optics, Inc. (RVO) from 2006-2018, serving as their Vice President of Global Regulatory Affairs & Quality Assurance, where she was responsible for U.S. product approvals, international product registrations, and assuring the highest quality of products. Prior to joining RVO, she served at FDA in the Division of Chemistry and Material Science (FDA/CDRH/OSEL/DCMS). Ms. Porter has experience in IDEs, PMAs, 510(k) and PAS for permanent implants.
Ms. Porter earned her BS degree in Engineering from the Harvey Mudd College, and an MS in Biomedical Engineering from the University of California, Irvine.
Karthik Ranganathan
Karthik Ranganathan has extensive experience in leading both early-stage and >$1B healthcare businesses that span capital equipment, disposables, application software, SAAS and service offerings.
Over two decades, he has built high-performing global teams that shaped strategy, led product development, drove commercial execution, directed operational planning and achieved growth through M&A.
At Becton, Dickinson and Company (BD), Karthik had multiple impactful roles in the US and in Asia. In particular, while leading the global BD AlarisTM infusion pump business, he navigated one of the company’s most complex business turnarounds, achieving regulatory compliance objectives as well as revenue recovery and operational scale that set a new performance benchmark.
Prior to BD, Karthik was the first employee at PocketSonics, a startup where he played a foundational role in developing a low-cost, handheld diagnostic ultrasound imaging system. He also served as a Visiting Research Scientist at the University of Virginia.
Karthik holds an MBA from Harvard Business School and a Ph.D. in Biomedical Engineering from the University of Virginia.
Beyond his professional endeavors, Karthik serves on boards and advises startups, contributing to the advancement of deep-tech innovations and entrepreneurship.
Mike Hill
Michael Hill is the Managing Director of Octane Capital Markets, as a part of the Octane Capital & Growth division. “Mike is the ideal person to serve in this new capacity”, said Bill Carpou, CEO of Octane. “He has walked in the shoes of the entrepreneurs we serve and understands the obstacles companies face to raise capital as they start their journey. Mike is client focused and has delivered results since joining Octane.” Michael is an experienced entrepreneur and angel investor with a deep passion for helping startup technology and medical technology companies advance their business models. He has co-founded, grown, and created liquidity for investors at two startup software companies and a professional services business which he ran for 25 years. Prior to leading his own ventures, he worked for Merrill Lynch, Xerox, and Orco Block Company. He also worked with the Small Business Development Center (SBDC) hosted at California State University, Fullerton where his teams helped the owners of small businesses secure more than $100 million in funding solutions.
Past Speakers:
Tonya Porter
Manny Villafaña
Amr Salahieh
Kris Shah
Stan Lapidus
Jeffry Weinhuff
Ramgopal Rao
Lishan Aklog
Stanton J. Rowe
Virginia Lang
Mickey Urdea
