Overview
The Biodesign Bootcamp aims to 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.
Course Description & Learning Outcomes
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 different clinical trial stages, basic statistics concept, and implication of clinical endpoints used
Market Access Competency (Basic)
Apply principles of coding, coverage and payment
Schedule
End Date: 28 Feb 2025, Friday
Location: To be informed upon confirmation, NA
Skills Covered
PROFICIENCY LEVEL GUIDE
Beginner: Introduce the subject matter without the need to have any prerequisites.
Proficient: Requires learners to have prior knowledge of the subject.
Expert: Involves advanced and more complex understanding of the subject.
- Health and MedTech (Proficiency level: Proficient)
- Biodesign (Proficiency level: Proficient)
- Design Thinking (Proficiency level: Proficient)
