Medical Device Playbook
Toronto 2025
Scaling & Selling in MedTech’s New Regulatory Reality
By Invitation Only – November 5, 2025 – Toronto
Medical Device Playbook returns to Toronto, 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.
If you believe you should be part of this exclusive forum, request an invitation.
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 Toronto 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: MaRS Discovery District
Date: November 5, 2025, 8:30am-6:00pm
Attendance: By Invitation Only
Only a select group of industry leaders will receive an invitation. If you believe you belong among this group, apply for an invitation.
Request an Invitation
Spots are extremely limited. If you believe you should be part of this exclusive forum, request an invitation today.
Presented by
Co-host
Top-Tier Sponsor
Sponsor
Community Partner
For more information, please contact StarFish Medical Marketing.
Sessions
Building a New Paradigm: Field Notes from the Front Lines
What happens when solving the real problem means rejecting the status quo? CL Tian is transforming medical device sterilization — not by breaking in, but by charting a new course altogether. This talk explores what happens when the path to success disrupts entrenched systems, reveals misaligned incentives, and puts billion-dollar revenues at risk. From early missteps to institutional resistance, and the hard work of building a new ecosystem, it’s a candid look at the realities of driving change.
Integration Lessons from Both Sides of the Table
Buying is easy. Integrating is hard. With leadership roles at Baxter, Boston Scientific, and now Sinaptica Therapeutics, Ken Mariash has lived both the strategic and operational sides of medtech acquisitions. He’ll share real-world stories—successes and stumbles—about what makes integrations succeed (or fail) inside major franchises. Plus, how those lessons are shaping his approach to scaling a neuromodulation startup tackling Alzheimer’s disease.
MedTech Vital Signs Report – Canada’s health tech sector at a critical juncture: challenges, opportunities, and investment signal
This session will explore key findings from the annual MaRS MedTech Vital Signs Report, highlighting the sector’s major challenges, emerging opportunities, and shifting investment landscape. Join us for a pulse check on where the industry stands and where it’s headed.
From Innovation to Standard of Care: Breaking Through Market Resistance
Changing the Standard of Care takes more than innovation—it requires overcoming both market resistance and adoption barriers. MedTech companies must confront physician skepticism, clinical inertia, and structural hurdles such as payor coverage, hospital committees, and guidelines. Drawing on lessons from the CryoCath/Medtronic cryoballoon journey and other medical device launches, this session shares candid vignettes that reveal how resistant markets shift. Attendees will gain a practical playbook to train effectively, nurture champions, track leading vs. lagging indicators, align with gatekeepers, and apply proven strategies to accelerate the journey from breakthrough idea to embedded Standard of Care.
Getting to “Yes” in Today’s FDA Landscape — Turning Smart Regulatory Strategy into a Competitive Advantage
With over 20 years guiding medtech innovators through the FDA maze, Kristin Zielinski Duggan has seen how the clinical trial landscape is evolving—and how smart strategy can turn complexity into opportunity. She’ll share what’s changing in FDA expectations for clinical evidence, how to design trials that accelerate review, and practical ways to make your path to “Yes” faster, smoother, and more predictable.
Start-Up to Public: Navigating Growth, Risk, and Hard Lessons in MedTech
Ever wondered what it really takes to grow a MedTech start-up into a public company? Stefano Picone, CFO of Conavi Medical, has been there. From guiding a start-up through a reverse takeover to making tough strategic and financial decisions, Stefano will share candid lessons learned, the pitfalls to avoid, and the insights he wishes he knew along the way. This session is packed with practical takeaways for founders, investors, and MedTech leaders looking to scale with confidence.
Behind the Deal: Insights from Two Major MedTech Transactions
Peter van der Velden, Managing General Partner at Lumira Ventures, takes us inside two recent high-profile MedTech transactions. He’ll share how the deals came together, the key decisions that shaped them, and what these experiences reveal about today’s MedTech investment landscape.
Peter van der Velden
State of the VC Market
Sam will share stories of recent investment and exit transactions as well as his thoughts about how he and iGan think about opportunities in the medtech market in 2025.
Design, 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.
Speaker Bios
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.
Ken Mariash
As CEO of Sinaptica, Ken is leading the team to advance the company’s personalized precision neuromodulation therapy for Alzheimer’s.
Prior to Sinaptica, Ken has 20+ years leading and growing new business ventures on both the ‘Buy Side’ and the ‘Build Side.’
He started his career in management consulting at Charles River Associates, then jumped to industry at CSL, then Baxter BioScience (now Takeda), and Boston Scientific, with leadership roles in marketing, strategy, and corporate development. At Boston Scientific’s nearly $1B Neuromodulation division, he was the global commercial lead for the highly successful Cosman RF ablation business he helped acquire.
He also built the division’s Strategy function, providing leadership in areas including strategic planning, BD assessment, R&D portfolio management, digital strategy, and investments in next-gen platforms & new indications. In 2019 he joined EBT Medical, a venture-backed, clinical-stage startup developing a disruptive neuromodulation device for overactive bladder, where he oversaw all commercial aspects.
Kristin-Zielinski Duggan
Kristin Zielinski Duggan combines a background in biology and economics to advise companies on scientific and FDA regulatory challenges with a strong focus on business needs. For over 20 years, she has counseled innovative companies on the development and regulation of medical devices, pharmaceuticals, and combination products.
She has extensive experience across the FDA regulatory process, including regulatory strategy, pre-submission meetings, preclinical and clinical programs, IDEs, and preparing regulatory submissions such as 510(k)s, de novo petitions, and PMAs. Kristin also handles appeals and has led preparations for dozens of advisory panel meetings—including 510(k) reviews, PMAs, general issues panels, classification panels, and every Medical Devices Dispute Resolution Panel (MDDRP) meeting to date.
Her work extends to compliance issues such as 483 and Warning Letter responses, adverse event reporting, recalls, DOJ investigations, product liability litigation, and due diligence for investments and acquisitions.
Kristin’s expertise spans a wide range of therapeutic areas, including software, cardiovascular, orthopedic, gynecologic, radiology, gastroenterology, wound care, dental, plastic and reconstructive surgery devices, minimally invasive surgical tools, and in vitro diagnostics.
Billy Lai
Billy Lai is the Managing Director of StratFi, a strategic finance advisory firm supporting high-growth MedTech companies. Previously, he was an investor at iGan Partners, where he helped deploy more than $200 million into early- and growth-stage MedTech and Digital Health ventures, partnering with founders from seed through exit. Billy specializes in financial strategy, fundraising, and capital efficiency, helping innovators navigate growth and scale with confidence.
Jeff Silver
Jeff Silver is a global marketing and medical education executive with over 30 years of experience bringing innovative medical technologies to market. He has led U.S. and international launches across startups, acquisitions, and Fortune 500 companies, including cardiac ablation devices that transformed the standard of care for atrial fibrillation. Jeff has directed marketing organizations, overseen physician and field education, and developed advanced training solutions from live programs to simulation systems. Known for spotting blind spots in launch planning and mentoring future leaders, he has helped accelerate adoption, reduce risk, and drive successful global introductions of transformative therapies.
Stefano E. Picone
Stefano Picone joined Conavi Medical in March 2015. He previously served as Vice President of Finance & Business Development, and prior to that, as Director of Finance. Since its incorporation, Mr. Picone has served the President of Conavi Medical US, which is the company’s wholly-owned US operation. He has extensive medical device start-up and finance experience and is a member of the board of directors of Xpan, Inc., and formerly was on the Commercialization Advisory Council for Holland Bloorview Kids Rehabilitation Council. He has been an invited presenter at the Sunnybrook Medventions lecture series as well as to the Ontario Bioscience Innovation Organization. Mr. Picone has a Bachelor of Commerce from the Rotman School of Management at the University of Toronto and is a member of the Chartered Professional Accountants of Ontario.
Sam Ifergan
Sam is the Founder and Managing Partner of iGan Partners and has over 20 years of entrepreneurial, technology and venture capital experience. Sam founded iGan Partners in 2013 and is now the largest healthcare venture capital investor in Canada. Sam is actively involved in evaluating, structuring and executing iGan’s investments. Collectively iGan has supported the creation of over 20 successful medical device and tech companies in Canada.
Sam works very closely with portfolio companies and is actively involved in their commercialization. He serves as the Chairman of eSight and MolecuLight and sits on the board of seven other MedTech companies. Prior to founding iGan Partners, Sam co-founded and exited several tech companies including Visual Sonics, Tri-Link Technologies and Brighter Minds.
Sam holds a Bachelor of Electrical Engineering from McGill University and an MBA from the John Molson School of Business.
Eric Olson
In over 25 years in design consulting, Eric has led major design and innovation programs for consumer and medical device clients, including Abbott, Starkey, CareFusion, Procter & Gamble, Midmark, and Boston Scientific. Eric’s leadership and enthusiasm engenders a high level of creativity and design sophistication from his project teams. He blends his aesthetic sensibility, end user empathy, and strong awareness of healthcare product development processes and business objectives to translate program requirements into compelling products with market appeal. Under Eric’s leadership, products have won some of the industry’s top design awards, including BusinessWeek’s IDEA Awards, the CES Innovations Awards, the Medical Design Excellence Awards, the Chicago-based Good Design Awards, and the iF International Forum Awards.
He has been a speaker and panelist over the last ten years at conferences across the US on Med Tech, Wearables, Biomimicry, and Connected Health.
He has served as a judging panelist for GoodDesign and BME-IDEA competitions and is a frequent guest lecturer at UCLA, USC and Art Center College of Design. Eric holds tandem design degrees from UCLA and Art Center College of Design.
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
