For designers, there’s nothing quite like standing beside a physician immersed in a medical procedure—nurses and technicians intent on their tasks, equipment flashing and beeping all around, low light, and moments of high anxiety. To be honest, our presence makes the medical staff a little nervous.
Things relax after a few procedures, when the medical team no longer cares that the design team is lurking with our questions and cameras. That’s when we really see what’s going on: the workarounds, the tricks, the stresses, and the mistakes.
It’s fascinating to watch skilled medical professionals do their thing in real time. It makes us optimistic that our design team can help improve their outcomes through good design.
Twenty years ago, Continuum was asked to work on a device to be used in the emergency room that could distinguish between a heart attack and indigestion. The first thing I did was drive over to the local ER and walk in. On that day, it was not busy, so I introduced myself to the head nurse and asked if she wouldn’t mind showing me around the ER and answering a few questions. She was happy to show me the space, let me take a few pictures, and answer my questions. My sister-in-law is also a nurse, and she, too, gave me a tour—around the ER at the hospital where she worked.
In the end, gaining all this access helped inform the architecture of the device, its level of mobility, and how we handled the user interface.
Walking into the local hospital and asking if we can “take a look around” just doesn’t work anymore. Things have changed (three things in particular): patient privacy, infection control, and compensation. All three are challenges to our work as designers. Here’s how we get through the fortress wall.
1. Respect Patient Privacy
Patients are now used to signing a document at check-in that allows their medical records to be shared with the caregivers and organizations working to diagnose and treat them. For signing the document, they are given a promise that their information will remain within the context of their care. Asking for access to patients to conduct research, in the middle of this highly regulated and secure environment, usually elicits a fairly long, blank stare.
The Health Isurance Portability and Accountability Act of 1996 (HIPAA) has resulted in stringent protection of patient information both physically and electronically. It all makes sense, and I appreciate it as a patient—but as a designer conducting research, it represents another barrier to access into medical spaces.
How do we get around this barrier?
After we gain consent from the hospital administration to be on the floor, we provide patient consent forms to the physician when we want to shoot images or video of a procedure. We avoid any direct patient-identifying images or video. We are typically interested in the interactions of the physician or support team, not the patient. In addition, if we can’t remove the patient information from the active monitors in the room, we scrub any identifying patient images or information in post-production. To blend in and reinforce that we designers understand and respect a patient’s right to privacy, my teammates and I each wear a large name tag (which displays our photo, name, and reason for being in this medical environment).
2. Manage Infection Control
Having a team of designers roll in off the street, shake hands, and spill equipment around the break room may raise some legitimate concerns about the level of sterility on that hospital floor.
The Center for Disease Control (CDC) estimates that you have a 4% chance of picking up a healthcare-associated infection(HAI) in U.S. hospitals. That’s actually pretty high, so hospitals large and small recognize the need to get this number down and their efforts are noticeable. Today, many of the hospitals in which we conduct research require a credentialing company to confirm that we have all the right immunizations and vaccines for each institution. In addition, we are required to review and follow each hospital’s specific policies on infection control.
On site, we wear the appropriate gowns from head to toe, wash our hands often, put on gloves and face masks, and cover and wipe down any equipment we may have with us. Of course, these steps not only reduce the chance of infection for the patient and medical team, but for our team as well.
3. Navigate Complex Rules Around Compensation
Our research participants are typically compensated, including physicians. A few years ago the Centers for Medicare and Medicaid (CMS) released their final regulations implementing section 6002 of the Affordable Care Act. The 72-page document titled Transparency Reports and Reporting of Physician Ownership or Investment Interests, sometimes referred to as the “Sunshine Act,” can be a bit confusing. The intent is to shed light on or make transparent the compensation between a physician and a manufacturer. Because it’s relatively new and obscure, there can be some reluctance from both the manufacturer and the physician to participate in research.
Physicians have always been busy and difficult to recruit for projects. Our clients often have a working relationship with physicians or medical personal that includes some type of compensation that they manage and report. Early in the development process, there may be several reasons why a manufacturer would like physician feedback, but at the same time not want the physician to know who they are. In certain situations, we set up a double-blind round of research in which participants are compensated but they don’t know who the manufacturer is, and vice versa.
Access to medical staff and environments has become more challenging over the past 20 years, and we can expect the trend to continue. The ability to conduct primary research across hospital settings is critical in gaining insights that inform meaningful improvements to medical devices. To assure that we have ongoing access to medical environments, designers and researchers must be aware of new regulations that effect this space, like infection control and patient privacy laws. Of course it’s more than just being aware. We need to understand how they affect our ability to gain access, and then proactively adapt our tools and techniques to meet all the requirements.