Medical Device Commercialization
Progress report for pre-revenue start-ups:
Congratulations! If you are reading this you have a product or technology that addresses an unmet clinical need in an innovative way. But what now?
Understanding exactly where you are on the medical technology commercialization path is no easy task. Is your approach balanced? Is product development getting ahead of itself? Is it time to consider other commercialization tasks?
Take this brief survey, and fix your position!
Congratulations! If you are reading this you have a product or technology that addresses an unmet clinical need in an innovative way. But what now?
Understanding exactly where you are on the medical technology commercialization path is no easy task. Is your approach balanced? Is product development getting ahead of itself? Is it time to consider other commercialization tasks?
Take this brief survey, and fix your position!
What best describes the progress of your product or technology concept development?
Product Development Milestones, Costs and Timelines defined
Proof-of-concept prototype; entire device or specific design element(s) demonstrated
Prototype evaluation / major technical obstacles overcome / Usability considered
ALPHA Prototype or greater
UNSURE or N/A
What best describes your current Intellectual Property (IP) situation?
You have a written Intellectual Property Strategy
Provisional Patent Application / Trade Secret(s) defined
Prior Art Search performed / Freedom to Operate understood
Non-Provisional Patent filed
UNSURE or N/A
How well do you understand you market?
Market analysis completed / Sizeable market opportunity present
Competitive advantage / Value Proposition understood
Written commercialization strategy
Clinical champions established
UNSURE or N/A
How well do you understand your regulatory journey?
Indications for use defined
Device class assigned for desired market(s)
You have a written Regulatory Strategy
Pre-submission meeting(s) with regulatory agency ongoing or greater
UNSURE or N/A
What best describes your understanding of how you expect to get paid for your innovation?
Reimbursement Landscape understood, including applicable codes, coverage policies and payment rates
Overall reimbursement goals defined / Reimbursement Strategy approved
Reimbursement Strategy tasks implemented; codes match intended use, code modification / coverage expansion defined or new code plan
Reimbursement validated with clinical champions / mock purchase tracked
UNSURE or N/A
How much clinical evidence have you compiled so far?
You have a written Clinical Evaluation plan that demonstrates how you will acquire the needed evidence for regulatory and marketing purposes
Preliminary bench testing in progress or completed
Pre-clinical testing in progress; could include testing against standards, equivalence testing, animal studies
Pre-clinical testing completed or clinical trial plan approved
UNSURE or N/A
What best describes your Quality System readiness?
Compliance requirements understood for your market(s) / product specific standards identified
You have a written Quality Plan
Pre-market Quality Management System (QMS) with functional Design Controls, Risk / Supplier Management & Document Controls
All of the above + a Post-Market QMS or greater
UNSURE or N/A
How prepared are you for product manufacturing (internal or outsourced)?
No MFG. development tasks completed
Preliminary review of Product Design for Manufacturability
Bill of Materials with approved vendors and component pricing; tooling and fixturing needs understood
Preliminary design transfer plan, MFG instructions drafted; expected volumes understood
UNSURE or N/A
How are you currently funding your start-up?
Grant monies / Personal finances
Pre-seed funding – (Family, Friends, Fools) / Bootstrapping
Seed 1 - Loan / Angel Investor(s)
Seed 2 - Angel Investor(s) / Venture Capital / Accelerator
UNSURE or N/A
Your results are being processed...
A product development specialist with Koven's cardiovascular innovations will now review your survey answers and prepare your custom results! Please watch your inbox for our email in the coming days!
