Phase 0 Feasibility
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Who is a Phase 0 Feasibility Study For?
Kapstone Medical offers flexible and customized Phase 0 Feasibility Studies to many startups and physician-inventors who have early-stage medical device concepts.
How Can a Phase 0 Feasibility Study Help?
The purpose of Kapstone's Phase 0 Feasibility Study is to provide a multi-disciplinary assessment of a new medical device concept and to identify associated project risks and opportunities prior to investing more significant time and capital.
What Does Phase 0 Feasibility Enable You to Do?
- De-Risk Early: Build the foundation of a successful medical device launch.
- Evaluate Holistically: Feedback as appropriate from Product Design, Intellectual Property (IP), Regulatory Affairs, Manufacturing, and Commercialization.
- Open Possibilities: Brainstorming at this stage can help the strongest ideas surface before pursuing development.
- Advance Strategically: Working with an experienced and integrated partner who knows how to get your product to market.
- Get a Head Start: Completing feasibility activities early accelerates completion of the Phase 1 Concept stage.
"Describe their project management. Did they deliver items on time? How did they respond to your needs?
Kapstone is one of the best companies I've worked with in my career in terms of quality and project management skills. They follow up, respond quickly, adapt to new requirements. They have a very talented group who have a great deal of technical and also collaborative skills. The values shown throughout the process made a complex process seem simpler. Escalation was also modeled correctly and action plans were made according to everyone's input"
- Pablo Brenes, CEO of an R&D Company
Verified Review on Clutch
Phase 0 Feasibility FAQs
Why Choose Kapstone Medical for a Phase 0 Feasibility Study?
What are the typical deliverables in Kapstone's Phase 0 Feasibility Study?
Kapstone's Phase 0 feasibility study deliverables are customized to the needs of each project, allowing budget and timing to scale accordingly. While some items can be completed à la carte, Kapstone strongly recommends completing the technical and engineering viability, regulatory, manufacturability, and IP assessments together to ensure a comprehensive and risk-aligned feasibility report.
How does Kapstone's Phase 0 Feasibility Study assess technical and engineering viability?
- Concept Application: Assess the concept based on its intended and foreseeable clinical use. Brainstorm alternative designs.
- Design Constraints: Identify component-level risks related to items such as materials, tolerances, sealing, wear, and fatigue performance as applicable.
- Manufacturability: Ensure that Design for Manufacturability (DFM) is considered early.
How does Kapstone's Phase 0 Feasibility Study address Regulatory classification and pathway for a medical device?
How does Kapstone's Phase 0 Feasibility Study address manufacturing scalability?
There is a big difference between an early prototype and final production run.
- Cost of Goods Sold (COGS): Can this be manufactured and sold at a price point the market will support at scale?
- Material Availability: Are the raw materials readily available and do they have a history of biocompatibility?
- Supply Chain Considerations: Does the team plan to manage supply chain through a single-source point of contact like Kapstone Manufacturing, or will they have the capability to qualify and manage multiple suppliers in production?
How does Kapstone protect my Intellectual Property (IP) during development?
How does a Phase 0 Feasibility Study affect the overall New Product Development process?
By answering critical questions in Phase 0, you get a head start addressing several Phase 1 deliverables while building the justification required to secure your next round of investment.
Ready to get to work?
If Kapstone sounds like the right fit for your business or you have further questions, please reach out to our team.
