Medical Device Design Best Practices - Formula for Success

KMC Systems and Farm Product Development collaborate on medical device design - a formula for success

KMC Systems values its collaborative relationships with clients, R&D organizations and engineering consultants outside company walls, viewing these unique engagements as an integral part of the medical device product development process. KMC Collaborates for Medical Device Development

As an example, for a quarter of a century, KMC has had a relationship with a neighboring New Hampshire company, Farm Product Development, for the purpose of collaborating on medical device design projects in the early development stages and organizing a front-end engineering process for device usability assessment. To date, the collaboration has engaged in over two dozen product development projects.

The development team’s joint projects are predominantly in the life sciences sector for diagnostic laboratory equipment. Report cards on the success of the collaborative relationship of both KMC and Farm are aligned well with strong grades on relationship compatibility, historical performance results, and commitment to continuously improve the product development process. KMC’s experience has proven that sharing and leveraging resources builds bottom line results and optimizes design quality for all the value chain partners.

Farm is a full-service, ISO 13485-certified and FDA-compliant product development company with more than 40 years of experience providing development services for medical, life sciences, and consumer health companies. Its focus is on solving challenging medical device problems, protecting and enhancing the client’s value in the market, and increasing their IP portfolio.

Farm and KMC’s front-end engineering and user analysis studies are critical to the development cycle. It is at this crucial step where the human factors, ergonomic research, and user needs are merged with other technical and product requirements.

Jack Harkins, president of Farm Design, stated that his company takes "a common sense approach to the development process and allocates the necessary resources to complete a thorough usability review in the real world locations the device will be used in.”

Two teams are better than one upfront

The typical collaboration between KMC and Farm Design works as follows:

  • Each company assigns a project manager to the development team.

  • The collaborative team reviews the project requirements and design objectives and works together on the project scope, client proposal and sales presentation.

  • A project schedule is jointly established and the roles, responsibilities, reporting and communication process defined.

  • Weekly web conferencing meetings are organized, progress and risk tracker reports are updated, design challenges addressed, client priorities are reviewed and confirmed, milestones are identified and risk design analysis is completed.

  • Teams participate in the client meetings and progress updates throughout the project.

Harkins described his company’s role as “advocates in making the design correct from the start,” and how important the perception of the development team is to the client.

“The key is we look like a team, act like a team and function as a team, and our customers value this,” Harkins explained. Device companies like to know there are “one-stop shopping” options that cover all phases in the design process. KMC, with Farm’s additional skills, offers this to their customers.

In the marketing phase, KMC promotes the combined team as an integrated solution with multiple services under one contract. The front-end engineering is key to the success of developing a product that is safe and meets the user requirements. The Farm’s front-end research coupled with the client’s product specification provides a viable path for the collaborative KMC/Farm medical device design team to begin the medical device design process.

Added engineering power upfront is often needed to navigate the complex market and regulatory environment that medical device manufacturers face today.  An investment in the front-end engineering of human factors and usability assessments is not only important to remain in compliance with FDA regulations but it can also:

  • lower the number of product use and user errors

  • reduce risks associated with use of the device

  • lower training costs

  • reduce costly and unnecessary service and support

Farm’s product development engineering resources both reinforce and complement the KMC engineering resource pool for:

  • Identifying the highest market and product risks

  • Addressing regulatory compliance for product safety and human factors

  • Strengthening the focus on rapid product development

  • Leveraging design knowledge and experience

  • Expanding innovative capacity and resources

  • Promoting a technology positive milieu  

“The collaboration model augments our ability to provide a broad service offering across the entire medical device product life cycle. Leveraging the knowledge and experience of two 'best in class' companies is a real advantage for our clients. This is a well-structured, energetic, and refined model that aggressively confronts front-end product definition ambiguity. Avoiding this front-end product definition during this early phase can adversely and unexpectedly change the scope of a design project downstream,” noted Bob Evans, KMC’s marketing manager.  “KMC believes the Farm Design collaborative relationship provides an innovative edge that brings clarity to development and produces market-ready medical devices that meet or exceed our clients’ expectations.”

 

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Topics: KMC Systems, medical device design, IVD instrument development program, In Vitro Diagnostics, Medical Product Design, collaborative innovation, Medical instrument Design, medical device