Design for Medical Product Development

On the other hand, interviews and ethnographic observation, while qualitative, can be performed contextually, and provide deeper detail and relevance, albiet with less scientific rigor. Evidence-based design recommends a balance of both kinds of research to provide the best data set to medical product developers, and also discusses how to blend the two approaches - for example gathering quantitative data about patient movement while conducting observational research.

Similarly, evidence-based design discusses how to handle apparently conflicting or contradictory medical product research findings. Such situations are an opportunity to examine the root causes of the differences - for example did two similar studies provide contrasting results due to differences in the populations studied, or the particulars of data collection?

In other words, the EBD research approach is a realistic and pragmatic one. The mindset of gathering different types of data from different sources and then looking at the findings across the data sources is comparable to the triangulation approach that I employ in product design research.

Evidence-Based Design Vs. User-Centered Design

Presumably any medical product or interface design developer who has read this far would be wondering how evidence-based design relates to user-centered design. In both methodologies, the goals are very similar - apply appropriate product design principles to create effective, usable results. And while there is overlap between the two fields, there are also significant differences in their details. In fact, there are at least two critical differences between how evidence-based and user-centered design are practiced regarding medical product development:

• Published Research - In evidence-based design, there is a focused effort to document the best practices for healthcare environment design via journals, such as Healthcare Environments Research & Design Journal (HERD). In comparison, medical product development is a much broader, diverse field, and while there are publications and conferences, it is challenging to find focused sources around the effective design of a specific type of medical product, versus general guidelines for product design and development (e.g. ergonomics, human-computer interaction guidelines).

• Outcomes Measurement - A critical goal for evidence-based design is the definition and measurement plan for evaluating the outcomes of the medical product design. These are often based on clinical results and patient/staff satisfaction. Direct outcomes measurements is rarely a part of any user-centered design process. In medical product design, outcomes may be estimated prior to implementation through usability testing (an activity seemingly not given significant attention in EBD), and occasionally via post-launch evaluations.

Adapting Evidence-Based Design Methods to Product Design

It's a given that increasing the integration of published research and outcomes measurement would benefit the medical product development field. But we expect the reality of that will vary greatly with the particular types of products.

Medical product development would be an appropriate area to apply EBD methods. It already has the obvious connection with the medical field, and with that comes some of the necessary resources. For instance, both ergonomic/human factors periodicals as well as specialized medical journals address the effectiveness of tools for the growing field of medical product development for laparoscopic surgery. These articles address the effectiveness of tools from both the design and clinical outcome perspective, although require some learning & effort to understand the specialized vocabularies.

But finding appropriate reference information is only half the story in medical product development. Research is a cyclical process where those taking guidance from previous research must disseminate their own findings. This may be done formally, through the journals and conferences, or informally via blogging or trade group meetings. For example, the interaction designers association, while focused on interface design, is a great model of an online community sharing best practices and guidance for design on an as-needed basis. This bottom-up information distribution is also seen in social/professional networking sites such as the Medical Devices Group on LinkedIn.

More generally, the thoughtful planning and balancing of qualitative and quantitative methods advocated for in evidence-based medical design may be the strongest takeaway for product designers.

In the future, we expect that environmental designers/architects and product designers will work more closely in shaping the entire medical user experience. In such an integrated approach essentially every detail of the medical provider's and patient's experience will be considered - from the layout of the room to the ergonomics of a medical product to the usability of healthcare information systems - rather than designed as independent objects that must co-exist within the same medical system.

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