3. Concept Generation

3. Concept Generation

1. Brainstorming

   • useful rules
     • Defer judgement, Encourage wild ideas, Build on ideas, Go for Quantity, Stay focused, Be visual
   • Idea vs Concept
     • Organize resulting ideas and validate
     • Validation criteria
       • Need: Respond to the need statement?
       • Value: gives desired value?
       • Strategic focus: within the team focus?

2. IP

   • Patentability
     • Utility (must be useful), Novelty (new), Not obvious
     • Types of Patents
       • Provisional (initial application before utility)
       • Utility (full patent)
       • PCT: patent cooperation treaty (wont grant an international patent)
       • European: provides priority and search at European level (won't grant European patent)
     • Ownership
       • Inventor, Inventorship (list of inventors), Assignee (entity), Licensee (have permission to use)
     • Timing
   • FTO
   • Portfolio
     • Protects invention, manages competition, allows FTO, builds markets, provides revenue, drives business
     • Defensive
       • Prevent others from using the tech
     • Offensive
       • Prevents competitors from creating new approach

3. Regulatory Basics

   • Health Canada
     • Food, Drugs, Medical devices, Animal feed (FDA)
     • Classification Rules
       • Class I to IV, low to high risk
         • Regulatory Pathways =>
       • Rules 1 to 16. Depend on the nature of the device
         • Invasive (1-3)
         • Non-Invasive (4-7)
         • Active (8-12)
         • Special (13-16)
       • Final classification determined by the rule which assigns the higher risk
   • FDA
     • Product classification
       • 1. Divide into 'centers'
         • Drug, biologics, devices, diagnostic tech
       • 2. Divide into 'branch' aka discipline
       • 3. Divide into 'classes' according to risk
         • Class I: minimal potential harm & simple design
         • Class II: non-invasive & more complicated
         • Class III: Implantable, therapeutic, life-sustaining
     • Pathways
   • European pathways
   • Portfolio
     • Device Classification, Expected reg process, Reg. cost, References (legislation, ref documents)

4. Concept Screening

   • HTA
     • Evaluate social, economic, organizational, and ethical issues
   • Reimbursement Coding
     • Identifies what was done, how, and why
   • Business Models
     • Disposable products
     • Implantable products
       • Surgically implanted
     • Capital produts
       • Reusable devices that require a capital investment
     • Service, Fee per use, Subscription, Over the counter, Prescription, Physician-sell, Blend
   • Prototyping
     • Types
       • Is-Like, Feels-like, Looks-like, Works-like
     • Low-cost, Iterative, use it to help you think
   • Selection
     • Matrix
       • Example
     • List of features and evidence for the lead concept
       • Helps w investors

Images and files in the map