The Art of Contextual Inquiry in Medical Device Design

The Contextual Inquiry process helps design engineers to understand how the user interacts with a device. This research method helps the designer to understand user flows and needs and offers data to support decision-making for the design process.
Philip Remedios, CEO and Director of Design & Development for BlackHägen and Renée Bailey, Senior Manager of Human Factors Engineering at BlackHägen break down the importance of contextual inquiry ahead of MEDevice Boston. BlackHägen will be at booth# 432 at MEDevice Boston.

Here is a transcript of the episode.

Well, hello and welcome to "Let's Talk Med Tech." Thanks for coming out. How are you all doing?

Bailey: Very well! How about yourself?

I'm doing well. I believe the last time we saw each other in person was during MD&M South in Charlotte, NC.

Remedios: Absolutely! It was a privilege to meet you then.

Fun fact: I'm actually from a small town in South Carolina, but my mother grew up in North Carolina, so it felt almost like a homecoming for me at MD&M South.

Bailey: Same for me. I grew up in North Carolina, so I can relate.

 Awesome! Which part?

Bailey Coastal, NC, near the Outer Banks.

Have you ever heard of New Bern, NC?

Bailey: I sure have! That was the big town next door to where I grew up.

That’s where my mom is from.

Related:What Should Engineers Know About User-Centered Design?

Bailey: Got it! Oriental, NC. It’s a tiny dot on the map, but it’s there. That’s my hometown.

Oh, wow! Small world!

Bailey: It is!

I want to jump right into our topic today: the power of contextual inquiry in medical device design. But first, let's discuss your backgrounds in medtech and design. We've talked about where you're from, but let’s dive into your careers.

Remedios: Go ahead, Renée.

Bailey: Sure! I’ve been consulting for over 25 years in various industries, including highly regulated ones like medtech and pharmaceuticals. I’ve worked with these companies on both the corporate and commercial sides as a performance improvement consultant, and for the last ten years, I’ve focused more on the R&D side in human factors. My background in performance improvement also allowed me to incorporate instructional and training design for medical devices, which has been an interesting aspect of my career.

Interesting! Philip, how about you?

Remedios: My background is in industrial design and mechanical engineering. I try to use both sides of my brain. I’ve been developing devices and products for over 35 years. I started in the automotive industry as a car designer for about eight years before transitioning to general product design. I’ve designed everything from mass-produced toys to ventilators and lung machines. After about ten years, I realized my passion lay in designing products that enhance patients' lives, leading me to medical device design. I’ve worked on everything from single-use devices to large, low-volume machines, and it’s been a pleasure enhancing patient lives.

Related:Happier Human Beings are Better Employees

I’d love to hear your thoughts on some trends you’ve been seeing, but let’s dive into contextual inquiry. What is it, and why is it so important for medical device design?

Remedios: Contextual inquiry has been a powerful tool for our company, BlackHagan Design. It allows us to develop better designs suited to industry needs by observing how end users go through their workday. It’s not just about hearing their feedback; it’s about seeing their actual processes. This observation can reveal new opportunities for innovation and improvements in their work experience.

What would you say makes contextual inquiry so important for device design?

Bailey: To build on what Philip said, we often refer to it as a "show me, don’t tell me" approach. There are nuances you can pick up through contextual inquiry that might not come up in interviews or focus groups. These could include workarounds or habits that users have developed, which are critical to the design process. Observing users in their environment is essential for identifying these nuances that can inform better design and open up new opportunities.

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Remedios: I want to add that there are really two main outcomes of contextual inquiry: user needs and user aspirations. Understanding user needs helps minimize risk in device design, ensuring it’s intuitive and less prone to user error. This is essential for compliance with FDA requirements. User aspirations, on the other hand, focus on enhancing user experience and ease of use, which is important for marketing. Balancing both aspects is crucial.

Do you think designers are apprehensive to adopt this model? If so, why? How can we spread this approach further?

Remedios: I think creative designers are generally open to understanding user needs to inform their problem-solving. However, some conservative engineers and product managers may hesitate to deviate from established practices because it feels less risky. They might rely too heavily on voice-of-business research or key opinion leaders, which can lead to missed opportunities for innovation.

In what ways do you think contextual inquiry can help designers avoid being too narrowly focused on specific solutions?

Bailey: I believe we often see healthcare professionals burdened by the nuances of similar devices. I've conducted usability studies where participants get caught up in minor differences between devices, like whether to plug something in before connecting. It’s disappointing to hear that because healthcare professionals should focus on patient care, not device complexities. Contextual inquiry allows us to design with their workflow in mind, ensuring that we minimize those burdens.

Remedios: Additionally, many designers, particularly engineers, tend to adopt an inside-out approach. They focus on internal components and technical specifications, which is essential. However, understanding the outside-in perspective—where the end user wants components placed, how they interact with the device, and the overall layout—can lead to transformative designs. Balancing both approaches can result in better outcomes.

That brings up an excellent point. This seems like a novel idea and process, gaining traction and offering engineers a streamlined way to approach product design. I want to ask: How often do you find yourselves asking, "Who am I designing this for? The patient, the physician, or someone else?" How do you determine the end user when designing a device? Have there been instances where you had to tell a client, "This isn’t the audience you're targeting; this design isn’t benefiting the intended group"?

Remedios: Go ahead, Renee.

Bailey: Certainly. In contextual inquiry, you identify the primary users, making educated guesses during the planning stages. However, you might encounter other roles involved in decision-making or treatment. It’s crucial to consider that many devices are using predicate devices that have been on the market for years. There’s a principle in our industry: Are we making the next device only as good as the last one, which may be decades old, or are we innovating?

I can think of two examples. The first is replacing a legacy device that’s been on the market for 20 years while relying on outdated assumptions about how the procedure is performed today. We heard physicians say they prefer using a particular device because it allows them to take control without relying on an assistant. This indicates that the previous designs assumed an assistant would perform certain tasks when, in reality, the physician now handles those.

The second example involves reprocessing endoscopes, which have faced scrutiny due to infection risks. The design focused primarily on the physician and patient, excluding the technicians responsible for cleaning and disinfecting the devices. This oversight made it difficult to ensure proper sterilization. Contextual inquiry helps uncover such insights for both new products and next-generation devices or improvements to legacy designs.

Remedios: I want to add something about end-user approaches. A common mistake is that companies think they only need to speak to key opinion leaders (KOLs) to develop a top-tier product. While KOLs are subject matter experts, they may have skills that the average user does not. If you design specifically for a KOL, you may end up with a device that’s difficult for the average user to operate. Contextual inquiry can help you understand your user demographics. It's essential to design for the most challenging user, the one with the least experience, to ensure safety and usability.

What is the ideal environment to test your technology? You should consider both low-stress situations and high-stress scenarios.

Remedios: We call it simulated use. Your simulated use should closely resemble real-world environments, especially if you cannot test in those environments directly.

Many entrepreneurs, particularly those just starting out, believe their technologies will save the world but overlook the importance of real-world testing. Is that a common issue?

Bailey: Yes, absolutely. I have an example where we evaluated a device meant to assist with dosing life-saving medication for infants in critical conditions. The stressors of the environment—such as being in an ambulance, delivering medication while performing CPR—were significant. The device was not user-friendly under those circumstances. Without contextual inquiry, we cannot determine if we're truly solving a problem or making things easier in high-stress situations.

Remedios: I want to touch on robotic-assisted surgery. I was involved in orthopedic robotics 30 years ago. Adoption took time due to various concerns, including risk and agency oversight. Many surgeons were resistant to changing long-established methods, especially if new technology added time or complexity to their procedures. Companies must clearly demonstrate the value of their innovations to encourage adoption.

Philip, you’ve been in the industry for a long time. What trends have you observed in medtech design over the years?

Remedios: Covid has significantly impacted the future of medtech. The inability to access clinical centers prompted a shift toward home-based care. There's a trend towards wearables for 24/7 monitoring. Enabling patients to manage their care from home can reduce healthcare costs and improve outcomes. This distance care model is an exciting area many companies are exploring. Another trend is the move away from single-use devices towards more sustainable options. As sustainability becomes a priority, companies are looking at reusability without compromising performance.

What advice would you give to young engineers entering the field of medical device design?

Remedios: Renee, you go first.

Bailey: I encourage young engineers to always consider the end user and try to empathize with them during the design process. I once had an engineer observe a usability study, and after seeing actual patients struggle with the device, they wanted a usability suite in their engineering lab. This experience highlighted the value of understanding the end user.

Remedios: I’d add that young engineers should adopt design thinking at all levels. This approach encourages lateral thinking, helping teams explore multiple possibilities early on. Engaging in this way can lead to innovative ideas that might seem silly at first but could turn out to be game-changers.

If anyone wants to use the services of BlackHägen Design, how can they reach you?

Remedios: You can reach us at [email protected]. We monitor that regularly. You can also visit our website, blackhagendesign.com, for more information on how we can add value to your projects. We love what we do and want to leverage our experience to help you succeed. We’re eager to be part of your team!