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

 

Session dates

Full course (online and in-person segments): February 22 – May 4, 2023
Online only: February 22 – April 26, 2023

Time commitment

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

View Available Discounts

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.

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