Phase 0 Feasibility: How to Mitigate Risk and Control Upfront Cost in Medical Device Development

Kapstone Medical offers flexible and customized Phase 0 Feasibility Studies to many startups and inventors. The purpose of this 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.

Key Takeaways 

• De-Risk Early: Phase 0 Feasibility can act as the foundation of a successful medical device launch, identifying roadblocks by completing critical activities before starting a full development project.
• Evaluate Holistically: True feasibility goes beyond just Product Design and Intellectual Property (IP); to maximize value it may also include Regulatory Affairs, Manufacturing, and Commercialization issues.
• Open Possibilities: From a design standpoint, a Phase 0 Feasibility study often includes a critical brainstorming step thereby opening of the funnel of design ideas so that the best – not necessarily the first – idea is pursued further through development.
• Advance Strategically: Working with an experienced and integrated partner like Kapstone to complete a Phase 0 Feasibility Assessment enables startups to bridge the gap between a concept and a market-ready product.
• Get a Head Start: Phase 0 pulls in several key Phase 1 activities to be addressed in advance of kicking off a longer development project. Completing feasibility activities early accelerates completion of the Phase 1 Concept stage.

Why "Can We Build This?" Is More Important Than "Should We Build This?"

In the fast-paced environment of the medical device industry, "Should we build this?" is a question of vision. It comes from understanding clinical need and market potential. For an inventor or startup, the next critical question is "Can we build this?"

This is the essence of Phase 0 Feasibility. It is the due diligence needed to begin a longer development process by accounting for risks in each relevant discipline. 

Preparing a Great Idea for Successful Implementation

Most new product ideas begin with the identification of an unmet clinical need. However, this doesn’t always justify the start of a full New Product Development project.

Phase 0 is designed to help the early-stage company by evaluating a new product idea against four critical pillars:

1.  Technical & 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.  

2.  Regulatory

Assess likely regulatory classification and pathway (e.g., 510(k) considerations). Identify applicable standards and anticipated verification and validation (V&V) requirements. Identify possible predicate/comparative systems currently on the market.

 3.  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?

4.  Intellectual Property (IP) & Competitive Landscape

"Can we?" also applies to the legal right to operate. A Phase 0 feasibility study includes an informal "Freedom to Operate" (FTO) analysis.

• Conduct a preliminary IP landscape search
• Identify potential IP risks, design-around considerations, and areas of patentable novelty
• Review competitive and adjacent technologies

Why Kapstone Medical?

The Kapstone team has decades of experience developing complex medical devices of all classifications.
Founded in 2007, Kapstone Medical is a full-service, single-source medical device consulting firm that provides comprehensive, multidisciplinary assistance in Quality Assurance, Regulatory Affairs, Product Development, Manufacturing Solutions, and Commercialization Support.

Kapstone Manufacturing, a separate company in the Kapstone family, is a global contract manufacturer of medical devices. Both companies' medical device experts help customers navigate a cost-effective, top quality, and expedited route to market.

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.

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.

If you would like to apply this Phase 0 process to your new medical device concept, we invite you to contact Kapstone Medical for a consultation today.