Course Goals

As applied to class II and class III medical devices, participants will learn:

  • Common challenges that arise during the process of developing and launching new medical devices
  • The product evidence required to show the efficacy and effectiveness that may lead to clinical success
  • The aspects of business strategy, which include intellectual property protection, regulatory approval, reimbursement dynamics, technology valuation, and commercial landscape
  • The components of creating, customizing, and delivering a successful pitch

TRANSforming Care with Emerging, Novel Devices (TRANSCEND) explores the current climate for the development of class II and class III medical devices. This hybrid course begins with a 4-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
  • Examining the ways in which risk management informs device development processes
  • Designing a customizable pitch that deliver non-confidential information to key stakeholders

After laying the foundation online, participants will travel to Babson Executive Conference Center in Babson, MA  for three days of live in-person activities to put into practice the ideas and concepts learned online. Sessions include:

  • Personalized, expert feedback on slide decks and pitch delivery 
  • Q&A with medical device developers
  • Network building and collaboration skills activities

The course will culminate in a pitch competition where participants will have the opportunity to earn services, consultation, and educational offerings that are valued at over $15,000.

Meet the Course Director

Ilsa Webeck, MBA, founder & 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), Ilsa uses her skills to help identify needs, perform market validation analyses, scenario planning, strategic planning, and competitive assessments.

Meet the Presenters

 

Session dates

Online sessions will begin April 13, 2022. Please see course schedule for more information. 

Live in-person portion of TRANSCEND will take place May 16, 17, 18, 2022 at Babson Executive Conference Center at Babson College outside of Boston, Massachusetts (overnight stays for May 16 and 17, as well as all meals are included).

Airfare and/or transportation to and from Babson are the responsibility of course attendees.

Please contact us at transcend@catalyst.harvard.edu

 

 

Time commitment

Participants can expect to complete up to three hours per week of online coursework- including watching videos and completing assignments. The live in-person sessions at Babson Executive Conference Center run from 8:30 a.m. to 6 p.m. on Monday May 16 to Wednesday May 18, 2022. Breaks and meals are provided.

Application due

Wednesday, April 6, 2022

Eligibility

This course is best for early stage class II and class III medical device developers who have one or more of the following:

  • A functional prototype 
  • Intellectual property protection in the form of a provisional patent application or patent granted
  • A tangible product concept and desire to understand the processes, challenges, and how to partner with key stakeholders

Fee

  • Harvard affiliates: $3000.00
  • Non-Harvard affiliates: $4000.00
  • Cancellation and Refund Policy [PDF]
  • Note that this course includes a 3-day, 2 night stay at Babson Executive Conference Center. All meals will be covered during the course. Transportation to and from the venue will be the responsibility of the participants.
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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, TRANSCEND is intentionally reserving space for applicants from historically excluded communities to attend the course.

Apply

The application process opens December 15, 2021.