Biodesign Bootcamp: Deep Dive Into HealthTech Innovation with an End in Mind

Learning Outcomes

​​​Biodesign Bootcamp: Deep Dive Into HealthTech Innovation with an End in Mind is jointly presented by SGInnovate and Singapore Biodesign.​​ This workshop will help health & medtech innovators to internali​s​e 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. Course Objectives By the end of the workshop, ​you​ 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 - Collaborate 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 the regulatory class of a healthcare product as ​a ​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​ - Have ​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