2. Product Development
• Materials
Do you have to order and supplies or materials in order to develop your
product?
• Packaging
Does your product require packaging design and development?
• Equipment
Do you require any specialist equipment or is it advantageous to do certain
product development activities in-house, requiring equipment acquisition?
• Product Development Services
Will you outsource some or all product development services? What about
testing and validation? Industrial design?
• Other
Do you need any licenses to CAD software or other subscriptions?
3. Clinical Development
• KOL clinical need validation
Will you need to hire clinical Key Opinion Leaders to evaluate your product or
opportunity and provide advice or other consulting services?
• Ethics approval
Ethics approval for clinical trials
• Trial #1
Cost of your first (next) clinical trial
• Clinic Unit Prototype
How many devices will you need to supply to the clinical trial and what is
the cost of producing them?
• Clinical Development Services
Will you need to hire a firm to design, administer, or analyse your clinical
trials?
• Other
4. Regulatory Submissions &
Reimbursement
• Regulatory Filing
What is the cost of submitting regulatory applications
• Regulatory Services
Will you hire a supplier to advise or manage your regulatory approval
process?
• Reimbursement Services
Will you hire a supplier to advise or manage your pathway to
reimbursement?
• Other
5. Legal
• Legal Services – Business
Preparation of legal documents like NDA, terms of service, warranty,
founders agreement, shareholder agreement.
• Legal Services – IP
Freedom to operate, patent landscaping, IP filing, trademark registration,
copyright
• IP Filing Fees
• IP Maintenance Fees
• Other
Will you need ISO13485 or other quality systems in place? Will you be able to
manage this yourself, or will you have to hire a consultant to assist?
7. Marketing & Business
Development
• Website
• Search Engine Optimisation
• Marketing Collateral
• Advertising
• Demo Video/Animation
• Event Registrations
Do you need to join certain groups or attend certain conferences
and events in order to network and connect with collaborators or
customers?
• Marketing Services
• Other