Value driven innovation in medical device design: a process for balancing stakeholder voices

Area of Science:

• Biomedical Engineering
• Product Development
• Innovation Management

Background:

• Traditional linear innovation funnels are insufficient for the medical device industry due to complex, interdependent stakeholder needs.
• Multiple stakeholders (customers, business, technology) have diverse and often conflicting requirements in medical device development.
• Existing models fail to adequately capture the dynamic relationships and unique voices within the medical device innovation ecosystem.

Purpose of the Study:

• To present a spiral innovation process tailored for medical device development.
• To integrate the distinct needs of the customer, business, and technology stakeholders.
• To demonstrate the application of this process through a case study of a Class III medical device redesign.

Main Methods:

• The study applied a spiral innovation process encompassing four phases: Discover, Envision, Create, and Refine.
• A case study focused on the front-end redesign of a Class III orthopedic medical device.
• The process explicitly incorporated the 'Voice of the Customer,' 'Voice of the Business,' and 'Voice of the Technology.'

Main Results:

• The spiral innovation process effectively integrated diverse stakeholder requirements throughout the medical device development lifecycle.
• The case study demonstrated successful application in redesigning a Class III medical device, addressing complex needs.
• Value assessment of final design features was conducted post-refinement phase.

Conclusions:

• A spiral innovation process offers a more robust framework than linear models for medical device innovation.
• Successfully integrating customer, business, and technology voices is crucial for effective medical device development.
• The described methodology provides a practical approach for managing stakeholder complexities in medical device design and innovation.