Medical Device Playbook
Newport Beach 2025

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.   

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.

Darren Kraemer earned his Engineering Science degree from the University of Toronto, specializing in condensed matter and photonics. He then pursued a PhD in the U of T Chemistry department, focusing on time resolved molecular dynamics spectroscopy using mid-IR femtosecond lasers. During his PhD studies, Darren co-founded Attodyne Inc., to commercialize novel laser technology, ultimately producing a line of compact picosecond lasers for industrial applications, and led the company through to its acquisition. Afterward, as CEO of Light Matter Interaction Inc., he pioneered the use of novel short-pulse mid-infrared lasers for various surgical procedures, and  continues to explore innovative laser technologies and push the boundaries of the field.

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.

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, 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 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 Alaris^TM 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.

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.