Course badge
All course participants may receive a downloadable digital badge (shown below) that can be added to email signatures, LinkedIn profiles, and more.
Course Goals
Participants will learn:
- Common challenges that arise during the process of developing and launching new medical devices
- Product evidence required to show the efficacy and effectiveness that may lead to clinical success
- Business strategy, including intellectual property protection, regulatory approval, reimbursement dynamics, technology valuation, and commercial landscape
- Components of creating, customizing, and delivering a successful pitch
Formerly known as TRANSforming Care with Emerging, Novel Devices (TRANSCEND), Medical Device Development: Advancing from Product to Market (MDD) is a hybrid course that examines the current climate for the development of medical devices.
The course begins with a seven-week online session that includes:
- Case examples featuring real-world critical aspects and challenges in device development
- Key factors in regulatory decision-making
- Techniques for technology valuation and potential sources of funding
- Design best practices for a customizable pitch that delivers non-confidential information to key stakeholders
After laying the foundation online, participants will travel to Harvard Medical School for a one-day intensive to put into practice the ideas and concepts learned online. The course will culminate in a pitch competition where participants will have the opportunity to earn services, consultation, and educational offerings valued at more than $15,000.
Meet the Course Director
Ilsa Webeck, MBA, founder and managing director, strategic marketing and product development consultancy, MedTechStrategies
Ilsa Webeck combines creativity and systems thinking to solve problems and identify opportunities in the medical products space (devices, therapeutics and combination products). With more than 20 years of experience working with a diverse set of clients (from industry giants to small startups), Webeck uses her skills to help identify needs, perform market validation analyses, scenario planning, strategic planning, and competitive assessments.
Meet the Presenters
- Ajoy Basu, PhD, Product Development Consultant at alpha2infinity
- Alexander Adam, PhD, Principal at Hamilton, Brook, Smith, & Reynolds
- Ally Chang, PhD, MBA, Business Development Director – Entrepreneurship, Wyss Institute
- Andrea Light, MBA, Senior Director of Commercial Marketing at Smith+Nephew
- Carol Malysz, MBA, Executive Director of RI Bio
- Chris Tomosivitch, MBA, Chief Financial Officer at Paragonix Technologies, Inc.
- Dina Justice, MBA, Vice President of Regulatory Affairs at Terumo Medical Corporation
- Elliott Antman, MD, Physician at Brigham and Women’s Hospital, Professor at Harvard Medical School, and Director of Postgraduate Education at Harvard Catalyst
- Ibraheem Badejo, PhD, Senior R&D Director at Johnson & Johnson
- Jeffrey Karg, MS, President of Medical Device Group (MDG) Boston
- Laura Sorensen, Multimedia Brand Developer at Atelier LKS
- Lea LaFerla, BS, Vice President of Marketing Services and Business Development at SCORR Marketing
- Lyndsay Hercule, JD, Commercial and Technology Lawyer at Plexus Legal
- Maria Shepherd, MBA, President of Medi-Vantage
- Nancy Briefs, MBA, Founder and CEO of AltrixBio
- Paul Hartung, MS, Board Director of Leuko and Business Advisor at Clairways
- Ronda Taylor, BA, President of Kalis Taylor Marketing, Inc.
- Ross Zafonte, DO, President of Spaulding Rehabilitation Network and Senior Vice President of Medical Affairs, Research, and Education
- Seward Rutkove, MD, Chairman of the Department of Neurology at Beth Israel Deaconess Medical Center
- Shinikequa White, MBA, Director of Strategic Planning and Governance at Smith+Nephew
- Todd Herrmann, MBA, Professor of Practice and Director of the Undergraduate Programs, Simmons University
- Vanessa Hazzard, EdM, Harvard Catalyst Postgraduate Education
Session dates
Full course (online and in-person segments): February 22 – May 4, 2023
Online only: February 22 – April 26, 2023
Time commitment
Peer learning is an integral part of the course experience. To get the most out of the course, we encourage you to engage with other participants and complete the assignments each week. All participants must log into the course site and post in the discussion board within the first two weeks of the course. Those who do not post by March 8, 2023 will be removed from the course.
Online
Participants can expect to complete three to four hours per week of asynchronous coursework, including videos and assignments. One 90-minute synchronous webinar will be scheduled in February 2023.
In-person
The one-day in-person session will take place on May 4, 2023 from 8:00am to 6:00pm on the Harvard Medical School campus. Exact location will be sent to participants.
Breaks and meals are included in the session schedule.
Application due
February 8, 2023
Upon successful completion of the course, participants will receive a certificate of participation and Accredible digital credentials. This course does not offer CME credits.
Eligibility
The course is designed for professionals who seek to partner with key stakeholders and navigate decision-making processes and challenges, and open to:
- Early-stage medical device developers who have a functional prototype and/or intellectual property protection
- Executives, entrepreneurs, scientists, engineers, and other medical device development professionals with a tangible product concept
Past course participants have held job functions and titles such as:
- CEO
- Founder
- Professor
- Associate Professor
- Assistant Professor
- Research Scientist
- Engineering Manager
- Global Marketing and Product Manager
- Postdoctoral fellow
- Graduate student
- Senior Director of R&D Operations
Fee
- Free for Harvard-affiliated institutions
- Non-CTSA member: $2200.00
- CTSA member: $1650.00
- Cancellation and Refund Policy [PDF]
Harvard Catalyst Postgraduate Education is dedicated to addressing equity and intersectionality in medicine. Race, ethnicity, age, and sex can impact how different people respond to the same intervention. Diversity of thought and perspectives through the lens of a participant’s background contributes to an enhanced course experience, improved research and development, and overall better medical devices. The benefits of bringing more seats to the table extends far beyond this course. With this in mind, this course is intentionally reserving space for applicants from historically excluded communities to attend the course.