Risk management and medical device reimbursement lead product development
Pathfinder is the reality check that brings your business plan alive. Product definition includes the proof of concept and renderings that make the value stream clear and add impact to investor financing presentations.
Early on, Pathfinder ensures your product will meet the end user’s functional needs in an intuitive manner while delivering medical device reimbursement targets. Getting the device right results from diligence through:
- Field studies, interviews and competitive analysis of the user and their environment
- Identifying key stakeholders, a distribution strategy and providing a risk analysis
- Reimbursement strategies from value chain analysis
- Recognizing and considering sales distribution
- Designing for target distribution channel margins
- Designing to maximize intellectual property while identifying IP constraints
- Designing for reliability, durability and risk management
- Creating a clinical path to meet ISO 13845 and FDA medical device design control and documentation specifications
- Designing for Health Canada or FDA approval
- Planning volume projections with a manufacturing strategy that matches processes to requirements
- Planning for service requirements and sustaining engineering
A typical output would be a plan, a proof of concept, and some renderings suitable for financing presentations. It's often surprising how useful the results are in bringing your business plan alive.