The medical device and life science industries have traditionally taken their design cues from other industries, such as automotive, consumer products, and commercial applications. In some ways, they still do. However, medical device designs are incorporating many of the same technologies as consumer, automotive, art and the commercial space. Today, medical designs are pushing the envelope even further. For example, Artificial Intelligence and Augmented Reality are also being talked about and used within the scope of design for medical device solutions.
One great example of the use of AI in the process is how it is now driving the way medical systems are being sold. This is allowing design to push the boundaries of aesthetics and the previous system thinking, to new applications.
When we talk about aesthetics, it is important to talk about the appropriateness of aesthetics. This is a key phrase that we use a lot in the medical device and life science industries, “appropriate aesthetics.” What appropriate aesthetics means is that every product has its own purpose.
When you match the aesthetics with its purpose, you’ll communicate that product to the user in a much more clear and relatable fashion. A simple example of this is if a product is supposed to be rugged or ambulatory, it should have that communication of toughness in its design. In the case of a disposable device, it shouldn’t look like it’s going to last for 20 years. If it’s a precision product for example, how do you communicate that it should be treated with respect? If it’s cleanable, how should the surface be treated? These are considerations based on the environment. When done correctly, the aesthetics match and fit within that environment of where the product will live and be used.
To achieve these results, human factors are integral to the product design of a medical device because they help designers communicate to the stakeholders the importance of the iterative design approach, integrating visual cues for ergonomics, and so on.
Human factors has roots in engineering and is focused on ergonomics and general usability. The human factor group has been cross pollinated with the design community recently, which is a wonderful advancement. Their real purpose is to make sure that they mitigate risk and increase usability.
What good design does is it incorporates that intuitive design and aesthetic to help human factors. It helps users to be more interactive with the products intuitively. You can reduce, for example, instructions for use. You can reduce warning labels because it’s inherently obvious based on the aesthetics. The difference between good design and human factors, one is stretching on mitigating risk, one is going more towards personalization differentiation. There is this common ground where it comes down to general good product usability.
It is important to go back to the beginning and understand that the FDA is really only concerned about safety and efficacy. Market success is not important to the FDA. That said, design contributes to the implied use and increased performance of a medical device. Design also cares about that product reaching the customers core level of need and creating a desire to purchase that product. Finally, design can be the differentiation of one product over another.
There are other agencies that protect people from problematic design. The provisions of 61010 and 60601, which are IEC documents guiding lab equipment and medical design equipment, are “the Bible” for engineers as they develop products. The new revisions of these documents include human factors guidance and guidance documents from the FDA. The IEC documents also cover UL requirements that protect products from sharp edges, open vents or similar hazards of poor design. However, it’s hard to test aesthetics as it relates to safety. It does work in conjunction with ergonomics and good design. Obviously, a good design would eliminate a sharp edge that would be a potential hazard to a user.
In design aesthetics, intuitive usability and ergonomics are driven from good and well thought out industrial design and user interface design. With medical design, the regulatory bodies need to know how you got to your solution. This puts a lot more ownership on the development of usability testing, contributing to the ease of use and intuitive operation.
System architecture, interaction and aesthetics are three critical functions that are incorporated into industrial design and the User Interface that affect the overall usability of a finished good. The system architecture isn’t always correct from the beginning of the process. It is important to understand why components are placed in a specific location or not. System architecture is similar to that of your bone structure and how that product fits within the system level of where you’re placing the components for balancing within the hand. It can help give you a better degree of design freedom, and it can be the environment, how a product withstands your electrical and fluidics not creating a problem together, for example.
Interaction is the fit and form of how that product meets the users’ expectations. The better we understand how people think about a product, behave around it, or use it, the more successful a design can be created for the product to be intuitive for the various users and use cases.
Finally, the aesthetics of a product are paramount. The visual, the appropriate look and feel, that enhances expectations or differentiates the user experience and maximizes the brand language. Aesthetics is the form and the form is the first thing a person sees. Aesthetics are the perception that users get from that product, whether it’s a quality product, whether it’s a disposable, whether it’s supposed to be dropped on the floor or treated with care. It communicates the product’s purpose and brand.
Those three things combined together, executed correctly, is where you create award-winning products.
Industrial design has matured greatly since its inception. User Interface is relatively new. Augmented Reality is even newer. The combination of technology that has led design down this pathway is now becoming the champion to help humanize and simplify these new technologies in medical device design.
The role of industrial design today is as an advocate of the user. For example, when developing a product, the industrial design community is the ombudsman for keeping track of the patients’, nurses’, the doctors’ needs and bringing those insights back to engineers and the marketing teams to make sure that they’re not left out.
For their part, medical designers, are learning to speak different languages. Before they were speaking science. Today they are also speaking engineering, they are speaking medicine, they are speaking marketing and they are designing. Design is becoming that common bridge in the development process and the champion of the user.
Tor Alden, Principal of HS Design in Gladstone, NJ said on the recent podcast hsDNA, “…based on what I saw as an Industrial Design Excellence Awards panel member this year, medical designs are really becoming the leader and pushing the design trends forward. It has a unique affordance of going beyond styling and form to working collaboratively with the human factors and engineers, and also collaboratively with the marketing and doctors themselves. I’m really excited and I can’t wait to see what’s happening in the next five years.”