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Strategies to compress product development in the medical device field.

What are the problems inherent in traditional approaches to product design? How do medical device developers efficiently implement projects within today’s regulatory environment? How has this environment changed, and what case studies exist? How can the globalization of life sciences serve as a catalyst for reaching major markets and successfully navigating the development phase? How can brainstorming lead to successful device-to-market campaigns?

These are some of the questions medical device developers must ask when venturing into product development, and the questions design and engineering firms must when leading a product to market.

MPR Associates, Inc. has built a reputation as a leader in this field, with a successful track record of product development services across multiple disciplines. MPR handles all aspects of product development from the initial conceptualization and definition stages, concurrently integrating engineering and design, to rapidly prototype full systems, fabricate units for clinical trials, and manage technology transfer activities to manufacturers for full-scale production.

In a series of interviews with OneMedRadio, MPR executives identified the most important strategic decisions a design firm must make at the early, middle, and marketization stages of development. Below are some steps to consider at these stages, including navigating brainstorming, logistical product development, regulatory constraints, and marketing. Don’t forget to check out the OneMedRadio interviews with MPR Associates in the sidebar!

Brainstorming: A developer must analyze the mechanism or the tools of the product within the scope of defining user needs and user experience. How will a user interface with this product? What are all of the interfaces with this product? The user experience begins with the ‘out of the box’, as well as the first use of the product, and extends to the dispose of the product. Therefore a proper analysis of the product is a brainstorming session, which must allow a definition of how the product will be first received, together with the later use requirements.

MPR incorporates single brainstorming sessions and creates a mind map, a graphical outline of ideas that are brainstormed around a topic. MPR’s ‘six hats’ brainstorming program, which uses colors to direct the dialogue. The dialogue is directed to be at times entirely free flowing, only positive, only negative, very imaginative, and more.

Project Management: Essentially, project management is about reacting to the inevitable errors or unpredictable events — risk management. It is essential to have a single empowered project manager who’s accountable for the entire project. That may seem very obvious, however there is a tendency for multiple individuals accountable for different elements of a project, which MPR says is a poor design. Inevitably, such a system leads to miscommunication and an inability to make decisions quickly and efficiently. This contributes to late schedules, overrun budgets, and an inability to produce a final product that meets the standards and needs of stakeholders.

A proper risk management program takes into account the management of direct unpredictable events, however also incorporates indirect and causal variables. To mitigate risks, a successful design should define activities in a way that accountability is clear. This includes clear start and finish dates and clear expectations on which activities require a single ‘owner’.

Uniqueness of medical device sector: Medical device development projects are multidisciplinary, with a wide and diverse number of organizations involved. Clear communications points are the most important tool, and also the biggest challenge. Medical device projects often run on a tight and expedited deadline, and the regulatory environment is not as clearly defined as other industries. Precedent and case studies exist for many different situations, however the presence of unique organizations across multiple sectors muddies the regulatory picture. Thus medical device product development can be considered more challenging than other sectors.

Regulatory constraints: The FDA has increased their level of expectation, in particularly with regard to risk management, human factors, and designing to prevent the possibility of use error. This increased attention is justified, especially with regard to human factor. Design and engineering firms must be receptive to more aggressive regulatory bodies and adapt accordingly.

Reducing risk: The ideal product development process suggests that the highest risk item is inherent in the technology early in development. These activities are done while the total investment on the device is still low. It is essential to identify a device’s greatest risk in the preliminary phases and engineering feasible solutions to solve these risks. While this process takes time, designing a device that incorporates these solutions early in development is significantly cheaper and more productive than attempting to incorporate these same solutions into a fully developed product. When effectively managed, technical risk is greater than the value.