Cambridge Healthtech Institute is pleased to incorporate the addition of our skill-based Training Seminars to the Molecular Medicine Tri-Conference. Training Seminars offer in-depth training and instruction on a specific subject area that isn’t covered at this level during the main program, symposia or pre-conference short courses. The topics of the Training Seminars include science-focused, business-focused, and personal development.

Our Training Seminars offer real-life case studies, problems encountered and solutions applied, and extensive coverage of the basic science and business issues underlying each topic. Experienced Training Seminar instructors offer a mix of formal lectures, interactive discussions and activities to help attendees maximize their learning experiences. These immersive trainings will be of value to scientists and business professionals from industry and academic research groups who are new to the life sciences field and want to advance, entering new areas of life science and not sure of a career path, or honing knowledge or skill on a certain subject to excel in a supporting role.

TS6: Non-Invasive Medical Diagnostics: Funding, Developing & Commercializing Novel Devices

Eric Sugalski, President, Smithwise

Course Description:

Novel diagnostic devices are a critical part of the rapidly evolving health technology landscape. Wearable systems are tracking long-term patient data that aid in delivery of new therapies. Handheld devices are capturing vitals and offering patients and providers information needed to treat chronic diseases. While technology is rapidly evolving, so are the clinical, regulatory, reimbursement and business factors that more often define the success and failure of new ventures. This workshop will introduce the key topics that are crucial for early stage innovators to understand in validating clinical needs, converging on potential solutions, and developing devices with an eye toward commercialization. Case studies and hands-on activities will be used to interactively work through the challenges facing new diagnostic ventures and the strategies that will optimize business success.

Detailed agenda:

• Need definition: Too often, early-stage medtech companies become laser-focused on their solutions, assuming that the unmet need for their technology and product is obvious. This workshop will start by clearly defining unmet medical needs, exploring alternative modes of addressing them, and developing a clear and concise need statements.
• Concept development: Participants will work in teams to generate new diagnostic device concepts that address the formulated need statements. Concept brainstorming and down-selecting methods will be introduced and practiced within team exercises.
• Patent analysis: Basics of infringement and patentability will be introduced. Teams will complete Boolean and classification searches, evaluating their concepts with respect to discovered intellectual property.
• Market analysis: Top-down and bottom-up market analyses will be introduced and practiced with the diagnostic concepts developed. Teams will define Total Addressable Markets (TAMs) in population and financial terms.
• Clinical analysis: Routes to obtaining clinical (and pre-clinical) data will be explored. This will include pre-market and post-market clinical data for regulatory and marketing purposes. Significant risk versus non-significant risk, agency versus Institutional Review Board (IRB) processes, Randomized Clinical Trials (RCT) versus Real World Data (RWD), and the basics of clinical study design will be discussed.
• Adoption / Adherence analysis: Methods to understand patient and clinician perceptions and preferences, as well as willingness to change behavior, will be explored. Usability mock-ups and prototypes will be among the strategies discussed to evaluate adoption and adherence.
• Regulatory analysis: The basics of regulatory pathways, primarily 510(k) and De Novo, will be explored. Agency informational meetings, pre-submissions, and product classifications will be discussed. Consumer product versus regulated medical device decisions will be explored.
• Payer analysis: The session will explore an array of potential payers including public and private insurers, hospitals, and patients. The hurdles, processes, motivators, and other factors associated with each payer group will be discussed.
• Product development strategy: After capturing a baseline understanding of the various risk factors facing a diagnostic device concept, product development strategies will be discussed. The process of continuing the risk reduction process through prototyping, testing, and iterating will be captured. Teams will develop and share example product development strategies for new diagnostic device concepts.
• Investment strategy: The stages and sources of investment, typical investment amounts, and expected milestones for each investment round will be discussed. Sample executive summaries and pitch decks will be shared as examples of what to prepare for early-stage investments.

Meet the instructor:

Eric Sugalski, President, Smithwise

As President and Founder of Smithwise, Eric Sugalski drives processes to attract and retain top talent and great clients, while maintaining an active role in the product development process.

During the first decade of his career as a hands-on design engineer with IDEO and Insight Product Development, Eric focused on surgical instrumentation, robotic systems, and drug delivery devices. When Eric launched Smithwise, he collaborated with technical innovators to translate their lab-based medical technologies into market-ready products. Throughout this process, Eric leveraged his technical background to provide clients with production-ready designs, functional prototypes, and smooth transfers into manufacturing. Eric now leads business development efforts for Smithwise while maintaining a day-to-day connection to ongoing client projects and his engineering and design teams.

Eric holds a B.S. in Mechanical Engineering from the University of Colorado, Boulder and an M.B.A. from the Massachusetts Institute of Technology. He is also a frequent lecturer at MIT Sloan and mentors students from MIT, University of Pennsylvania, Drexel University and Temple University. Eric lives in the Philadelphia suburbs with his wife and three children. In his free time he enjoys spending time outdoors with his family and catching up on the latest sci-fi TV series.

Each CHI Training Seminar offers 1.5 Days of instruction with start and stop times for each day shown above and on the Event-at-a-Glance published in the onsite Program & Event Guide. Training Seminars will include morning and afternoon refreshment breaks, as applicable, and lunch will be provided to all registered attendees on the full day of the class.

Each person registered specifically for the training seminar will be provided with a hard copy handbook for the seminar in which they are registered. A limited number of additional handbooks will be available for other delegates who wish to attend the seminar, but after these have been distributed no additional books will be available.

Though CHI encourages track hopping between conference programs, we ask that Training Seminars not be disturbed once they have begun. In the interest of maintaining the highest quality learning environment for Training Seminar attendees, and because Seminars are conducted differently than conference programming, we ask that attendees commit to attending the entire program, and NOT engaging in track hopping, as to not disturb the hands-on style instruction being offered to the other participants.