Design for Medical Product Development

When designing medical products, Bresslergroup’s typical product development process is utilized but tends toward higher levels of research and the integration of specialized expertise. Fortunately we employ industrial and graphic designers with significant scientific and medical product development expertise including:

• Therapeutic equipment

• Life support equipment

• Medical monitors

• Medical laboratory equipment

• Diagnostic medical equipment

• Surgical devices and equipment

• Consumer medical and home health devices

• Dental devices and equipment

• Scientific and hospital laboratory devices

As a matter of process, we work in cross functional medical product development teams including research, industrial, graphic and interface design, mechanical and electrical engineering. But with medical product development projects the need for integrated product development is paramount. The need to evaluate and answer user requirements, be aware of competitive patents and new patentable opportunities, comply with FDA and other regulatory compliance issues, and select approved or appropriate materials and processes for manufacturing drive tight collaboration among internal and client team members. Process documentation for FDA submissions is also critical in the medical product development process.

But regardless of device type, our priorities for medical product development begin and end with the user. And from a design perspective we need to remember that health care professionals are also friends and neighbors who interact with thousands of non-medical products in their lives outside of work. Across the hundred of medical and scientific devices we’ve helped develop, our research and understanding of end users wants and needs drives effective design solutions. An admittedly simplified breakdown of user influencer types follows with sample products and process descriptions provided for each medical product development phase.

But we think it’s also important to talk about the future of medical product development processes. We’ve been thinking and speaking with other experts about how the medical product development community can follow the movement begun by medical architectural professional around Evidence Based Design. If these sensibilities can be applied to places, why not products?

The medical field is a useful resource for consideration by medical product development professionals. The combination of rigorous, but varied procedures, and focus on measurable outcomes lends itself to efficient and effective practices.

Evidence-based design (EBD) is another important methodology that stems, not directly from the medical field, but from architecture and the design of medical environments.  While one might think that any design process should be, or at least could be, based on evidence, the term "evidence-based design" is specific to the "process of basing decisions about the built environment on credible research to achieve the best possible outcomes."

The goals and methods of evidence-based design should be quite familiar to anyone experienced with the scientific method, but because the approach accounts for qualitative as well as quantitative research and data analysis, it is highly relevant to user research in medical product development. The basic approach of EBD includes the following:

• Reviewing the existing body of research literature to determine relevant findings and recommendations for medical product developers

• Prioritizing and balancing referenced findings with primary data gathered from site visits, subject matter experts and stakeholders

• Hypothesizing about the potential outcomes of medical product design decisions, and then tracking those outcomes following design implementation

A simple example in the context of medical environment design (e.g. a new outpatient clinic), might begin with a review of published research on outpatient clinic design as well as reviewing decisions made on similar past projects. The Center for Health Design provides references to extensive resources for evidence-based design. Then conducting interviews with the medical staff (e.g. doctors, nurses, administrators) and consumers (e.g. patients, family members). The results from this research would drive the design decisions - for example, to provide sufficient collaborative working space in the waiting room for patients and their families. Outcome factors, such as patient satisfaction ratings and waiting time, would also be established and subsequently measured.

One reason we consider evidence-based design valuable to medical product development professionals is that the EBD research approach accounts for many of the methodological concerns that arise in qualitative, small-sample research. Evidence-based design makes the valuable point of considering any research method from the perspectives of both objectivity and context. That is, the most objective, typically quantitative methods, such as controlled laboratory studies or surveys, also tend to be the most removed from the actual design context. They provide scientific credibility, but may not account for the specifics of the particular situation. This is something we think we can improve upon in the typical medical product development process.

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