Run 1: Biodesign Bootcamp: Deep Dive Into HealthTech Innovation With An End in Mind

Equip health and medtech innovators, including healthcare professionals, researchers, product innovation engineers, strategic innovation managers and entrepreneurs with knowledge relating to multiple competencies under the Health and Medtech Innovation Skills and Competencies whitepaper.

This workshop will provide learners with perspectives encompassing design thinking, product development, regulatory, intellectual property, clinical trial planning, business planning and market access.

By the end of the workshop, serious health & medtech innovators will be able to internalize and apply the validated Biodesign framework of Identify, Invent and Implement towards structuring any new health and medtech innovation projects from a needs-centric and holistic view with an eye towards commercialization and adoption.

Learning Outcomes

Product Development Competency (Basic):

• Demonstrate ability to apply the Biodesign Framework to unmet healthcare/clinical needs and design a needs specification document based on focused research and stakeholder engagement.
• Apply ideation strategies to brainstorm possible healthcare solutions and where it would meet gaps in the patient/user journey and choose and screen based on a fundamental understanding of IP, regulatory, business and reimbursement model.
• Define and prepare prototyping plan and early risk assessment.
• Assess technology risks and develop functional proof-of-concept prototypes, and determine what tests are required to de-risk the project.
• Collaborates with different internal stakeholders (e.g., engineers and scientists) to define product requirements, develop prototype and validate results.

Regulatory Competency (Basic)

• Conduct preliminary research to determine regulatory class of a healthcare product as medical device, drug, combination or IVD.

IP Competency (Basic)

• Explain basic IP anatomy, types of IPs, IP regulations, IP lifecycle, costing and types of IP instruments.
• Apply principles of patentability and freedom to operate.
• Prepare a preliminary prior art search to evaluate healthcare innovation idea to inform feasibility.

Business Planning Competency (Basic)

• Prepare a preliminary market analysis (top-down and bottom up)
• Apply basic presentation and pitching proficiency
• Has an overview of fundraising and investment landscape (i.e., public and private funding sources and options

Clinical Trial Competency (Basic)

• Apply basics of clinical trial planning: overview, pros and cons of study designs (e.g., RCT), clinical trial ethics guidelines (e.g., HBRA/IRB), timeline of different clinical trial stages, basic statistics concept, and implication of clinical endpoints used

Market Access Competency (Basic)

• Apply principles of coding, coverage and payment