By Lena Levin, Co-Founder and CEO, Via Surgical
Medical devices are not like standard consumer products. In addition to being designed for ease-of-use by the end user, medical devices must also be designed to adhere to a range of safety standards and regulations specific to the industry. Any small change made to improve user experience (UX) will inevitably need to pass muster under the eye of a government entity such as the US Food and Drug Administration.
It used to be that device manufacturers only paid attention to the needs of medical professionals in design matters, but this has changed as the industry has come to realize the importance of the patient’s experience. Therefore, efforts to provide a good UX must include considerations for both patients and medical professionals.
Get feedback in the early stages of product development
Even before a medtech company starts to design a device, it’s important to consult with surgeons first. The process should include gathering active and passive feedback by not only asking questions, but also by observing how the surgeons use devices in all types of situations. Design is of utmost importance for surgeons who use certain types of devices, performing multiple procedures and repetitive movements for extended periods every day.
In the feedback gathering stage, it’s also crucial to have a good, broad cross-section of users. For example, handheld medical devices must be suitable for the hands of a wide variety of users. Therefore, having male and female surgeons try out the grips on these devices will provide a wider range of insights than if a company is only soliciting feedback from male surgeons.
Because surgeons rely on their vision to see if a suture is in the right place, or to extract it from a patient, color is an important factor for devices. Ensuring that the color of the device is easily visible under all types of situations can have a tremendous impact on UX for both the medical professionals as well as patients.
UX extends to everyone in the OR
Even beyond the design of the device itself, a manufacturer must look at UX along every step of the product use in an operating room. The device doesn’t just appear in the surgeon’s hand. The UX of every single person in the operating room must be considered.
Packaging is a huge aspect to pay attention to. How easy is the device to identify when a busy OR nurse needs to grab one for the surgeon? How easy is the package to open or reclose? Labeling might not automatically come to mind when thinking about important UX features, but a package must clearly show what the device is and how many are in the package, as well as prominent badges to indicate the optimum storage temperature of a device.
When a medtech company is considering UX along a user journey, it should be a very holistic approach that examines every step in the process of use in an operating room. Device manufacturers have to enter the mind of each person who is, at any given moment, using their device and ensure that the design of the product or the packaging doesn’t impair the experience.
Understand the patient is also a user
Just as medtech developers interview surgeons during the design process for a medical device, they should also interview the patients about what they feel after a surgery and what the optimal path to recovery would be for them. Basically, device manufacturers need to get the patient’s point of view.
Some of this may seem obvious: patients don’t want to feel pain. But how does device design impact the post-op segment of the patient’s user journey? Take implants for example. When a patient leaves a medical facility, they do not want to feel the implants inside of them. Optimally, any temporary implant should be absorbable and disappear after their job is done. If an implant must be removed, how can it be designed for the least invasive removal procedure? These are important questions that a device developer can only answer with the aid of feedback from patients.
Risk analysis and UX go hand-in-hand
It’s rare for a medical device manufacturer to work with an industrial designer as part of the initial steps in the development of a product, while R&D engineers tend to focus more on making a product work and less on the user experience. However, it’s a good idea for companies to start consulting with designers at a very early stage, even if the person is not on the team full time. Schedule a pre-clinical lab, and then a post-market lab to validate and revalidate a device. Analyze the risks and hazards at every step along the user journey. Whenever any changes are made to the design, it’s critical to do another risk analysis.
Surgeons spend long hours in the OR, so it’s crucial that their experience with the medical devices they use be a positive one. Although other OR attendants and patients may spend varying amounts of time with a device, the same holds true for their experiences. This also helps with the adoption of a device, because a good experience leads to affirmative recommendations. As with any other consumer product, UX can ultimately make or break the long-term success of a medical device manufacturer, which is why it should be an integral consideration along all steps of the development process.
This article was originally published on MedTech Outlook.
About Lena Levin
Lena Levin is Co-Founder and CEO of Via Surgical, a leading developer of novel surgical fixation solutions. She served as Co-Founder and CFO of PolyTouch Medical, which was acquired by Covidien in 2011. As an expert in financial and accounting management of growth-oriented medical device companies, she has completed numerous capital raisings from private investors and OCS and completed an M&A transaction with a multi-billion-dollar international medical device company.