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

"By the end of the workshop, serious health & medtech innovators will be able to achieve the following enabling learning outcomes according to the relevant innovation skill and competency from the innovation training whitepaper listed below: 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 models -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 differe