This is a 5-day workshop for those looking to broaden their perspectives encompassing design thinking, product development, regulatory, intellectual property, clinical trial planning, business planning and market access.
Biodesign Bootcamp: Deep Dive Into HealthTech Innovation with an End in Mind is jointly presented by SGInnovate and Singapore Biodesign.
This workshop will help serious health & medtech innovators to internalise 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.
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
- 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 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
For enquiries please reach out to [email protected] or [email protected].
- Bachelor's Degree or equivalent
This 5-day workshop will provide you with perspectives encompassing design thinking, product development, regulatory, intellectual property, clinical trial planning, business planning and market access.
|Day 1 Agenda||Session 1: Opening and Introduction|
Session 2: Overview of workshop
Session 3a: Researching on Needs
Session 3b: Filling up of DSTM worksheet
Session 4: Need Criteria
Session 5a: Concept Generation / Initial Concept Screening
Session 5b: Brainstorm!
Session 6: Overview of Concept Screening
Session 6a: Concept Screening worksheets
Session 7: Debrief
|Day 2 Agenda||Session 8: Needs presentation|
Session 9: Introduction to DSTM template
Session 10: Asian Case Study
Session 9a: Need Research
Session 11: Preparation for Need Specification exercise
Session 12: Need review and development of need criteria
Session 12a: Sharing of Need Criteria
Session 13: Concept Generation and Initial Concept Selection
Session 14: Concept development and debrief
|Day 3 Agenda||Session 15: Review of Day 2 and Opening|
Session 16: Concept sharing on what was developed in Day 2
Session 17a: IP Fundamentals
Session 17b: IP in Asia
Session 17c: IP Exercise
Session 18a: Regulatory Fundamentals
Session 18b: Regulatory Affairs in Asia
Session 18c: Regulatory Exercise
Session 19a: Business models innovation in Asia
Session 19b: Business models exercise
Session 20: Medtech Innovation in Asia: Validating Needs and concepts
|Day 4 Agenda||Session 21: Concept Exploration and Testing|
Session 21b: Prototype Planning
Session 21c: Presentation of prototype
Session 22a: Reimbursement Fundamentals
Session 22b: Market Access to China
Session 23: Final Concept Selection
Session 24: Recap and Next Steps
Session 25: R&D Strategy, Design Control
Session 26: Clinical trials fundamentals
Session 27: Case studies of clinical trials
|Day 5 Agenda||Session 28: Ops Plan and Financial Modeling|
Session 29: Implementation in Asia
Session 30: Funding landscape
Session 31: Preparation for presentation
Session 32: Presentations
Session 33: Fireside Chat
Session 34: Closing