Using Clinical Observation to Facilitate Medical Device CommercializationUsing Clinical Observation to Facilitate Medical Device Commercialization

When developing medical devices or technologies, how can one ensure they will be adopted? The medical device industry has long wrestled with this question. Adoption within the medical world relies on multiple parties including patients, physician, hospital administration, insurance companies, and FDA. The Medical Innovation Fellows at the University of Michigan (UM; Ann Arbor, MI) has set out to lessen the anxiety that often accompanies developing medical devices. Over the past three years, the UM-Medical Innovation Center (UM-MIC) has used a formula developed by Inovo Inc. (Ann Arbor, MI) to enhance medical device adoption. Each July, a fresh team of full-time, postgraduate fellows set out to develop and commercialize medical devices using the Inovo recipe. The “secret sauce” of the process, which is engrained in the fellows from the onset, is to discover which problem is the right one to solve. As obvious as this may seem, it is often the most overlooked part of product development. Oftentimes, especially in healthcare, engineers create technologies and wait for business people to identify where it fits or what problems it may solve. Similar to a hammer blindly looking for a nail, this is not an efficient approach. By contrast, UM-MIC approach prioritizes the consistent identification of the best nail before even considering hitting it directly on the head.

Finding the right problem to solve is a process that requires a deep understanding of both the medical domain, as well as the needs and desires of both the customers and end-users. When attempting to gather information from these sources, past strategies included the use of surveys and interviews. More often than not, however, these attempts lead a product in the wrong direction. Consider that humans have a high capacity to adapt to their circumstances. Many underlying problems can go unnoticed because they are commonplace. Therefore, it is exceedingly hard for a physician or a patient to say what they really need or desire, because they cannot articulate what they do not know.

By using an innovation methodology, integrated with observational techniques shared by Steelcase Inc. (Grand Rapids, MI), UM-MIC fellows are able to discover these needs and desires. In fact, clinical observations make up the core of the fellowship program and are used not only to develop opportunities, but also to create solutions. This is not without hurdles, especially in hospitals where regulations and policies are stringent. The next few paragraphs will describe some of the best practices for observing used by the UM-MIC Fellows, and tips on how to observe in the clinical setting.

Different Settings

A true opportunity can only be defined when the entire system it affects is understood. An observation in an OR suite may have its origin in the clinic, or it may have a larger impact downstream in the ICU. The root of the problem and its consequences will never be discovered if observations are only limited to a single environment. For medical device development, there are two levels of environments that need to be considered. The first is the institutional level, which consists of hospitals ranging from centers of excellence to community hospitals to outpatient surgery centers. Each of these sites differs in the amount of resources (in terms of physicians, technology, and finances) available along with how each is managed business-wise. For example, a large center of excellence has many specialized surgical departments, whereas a small community hospital may only have one or two general surgeons responsible for all surgeries. This difference in resources can influence the definition of an opportunity because a problem seen at a community hospital may not be one at a center of excellence or vice versa. Observations in these diverse areas will help shape the scope of an opportunity, and establish the niche in which a solution would be best adopted.

The second level is the clinical one, which consists of all the settings a patient experiences while at a medical institution. This may include the waiting room, clinic, or consultation room, OR suite, ICU, or diagnostic rooms. The biggest difference between these areas is the type of practioner working in them, each with different personalities and points of view (all of which should be documented).

An example of this is the opportunity that the UM-MIC fellows discovered around reducing complications associated with vascular access. They watched many procedures in the OR and never realized there was an opportunity until they later observed the nurses in the ICU, performing a post-op sheath pulling procedure. During this observation, the fellows realized that both the patient and the nurse were experiencing pain. It turned out that most of the complications they saw were directly related to the way the vascular access was being performed in the OR. This would never have been discovered if the fellows limited their observations to one area. The exploration within all environments is necessary to fully define an opportunity, but getting into these diverse areas can be difficult, especially without the right training and contacts.

Arranging Access

When setting out to conduct clinical observations, the best bet is to begin with a large academic institution. As a result of the nature of the teacher-student atmosphere, it is common practice that physicians are often shadowed by residents, visiting scholars, and students. Before you begin, you will need to identify the domain space you desire to observe within the selected health system. This may be as broad as the discipline of surgery, or confined into a sub-specialty. Once the domain is chosen, you need to identify an initial point of contact. The person you are looking for is an employee within the selected domain, who will assist you in making connections to the clinicians. Each department has administrative offices, each staffed with clinic and OR schedulers, admin assistants, and managers who are tasked with handling the business side of healthcare. Of this group, managers possess the most authoritative power and are able to facilitate requests rather quickly. As you make connections, keep in mind that a physician’s schedule is always busy and sporadic; thus, knowing the person in charge of his or her calendar, as well as day-to-day activities is key. These first relationships made at the hospital are valuable since they serve as the gateway into multiple clinics and possibly different hospitals down the pipeline.

The next step, prior to beginning observations, is to fill out all required paperwork and complete observer training. Since most clinical observations include direct contact with patients, it is imperative that you learn and adhere to the Health Insurance Portability and Accountability Act (HIPAA) regulations. The HIPAA regulations were put into action to protect the privacy of patients while at the hospital. Policies for code of conduct and patient confidentiality are a couple of the standard forms that will also be required. Most hospitals require obtaining an identification badge. Some institutions may also require instruction for research training, prior to making contact with patients. At the University of Michigan, the Program for Education and Evaluation in Responsible Research and Scholarship (PEERRS) satisfies this deliverable.

As you begin your observations, the easiest starting point is either clinic shadowing or attending patient rounding. Both of these venues offer immediate access to physicians and valuable one-on-one time. Think of these initial engagements as a time for everyone to get comfortable with each other and understand the purpose of observations. As you articulate your objectives, buy-in may be slow, but persistence will win most over. Once a relationship has formed, ask for information about upcoming surgeries, or suggestions on other parts of the hospital to experience. More often than not, physicians will assign you to someone who will help you gain access anywhere that is desired. In theory, every part of the hospital is accessible, but showing up unannounced is not advised. In the healthcare setting, respect is everything, and as long as everyone (physician, nurse, technician, patient, and so forth) knows and understands the process, they are usually more than happy to assist observers. Remember, the objective is to take in diverse and natural observations. If people feel as though they are being watched, they will act differently, or by the book, because they feel their every move is being recorded. Therefore, the more time spent in one domain, the more you blend into the culture, which widens the door of opportunity on how the day to day operations actually take place.

Getting Comfortable

The first several observations should be performed with the “fly on the wall” or “spotting” technique. These methods allow you to become invisible and simply watch the environment and how everyone in the room interacts with it. Without talking or moving, stand in the same spot without disrupting the natural workflow. This allows the observer to become comfortable in the space, as the do’s and don’ts become quickly obvious. The approach will also help the practioner feel at ease with your presence and appreciate your actions within the space. As trust and comfort levels increase, a more interactive approach may begin.

Shadowing is a technique where you move with a practioner and observe their day-to-day routines and interactions. Again, it is important during shadowing to become invisible and not interrupt. Once these techniques are mastered the observer can move into probing for more information about the situation. In this case the observer asks the practioner questions about what they are doing, and most importantly, why they are doing it. Questions need to be short and focused, aimed at understanding the situation and the practioner’s emotions and thoughts. Being able to do this type of observation without disrupting any natural behaviors requires skill. Trying to do it too quickly without gaining clinician trust or knowledge of the flow within the environment can prove to be hazardous. This is why it is important to start slow and learn about the environment as much as possible before trying to interact with anyone, especially during a surgical procedure.

Another method that can help gain physician and staff trust is to show up early to all engagements including surgeries. This not only shows professionalism but also allows time for discussion with the staff members before the patients arrive. These discussions can be used for introductions or even just casual talk, either will let the observer and staff members become more comfortable with each other’s presence. This can also be accomplished by setting up engagements or interviews with practioners to discuss related topics before any observations are made. For example, if the next surgery listed is an aortic aneurysm repair, try and set up a meeting with the physician doing that case to talk about aneurismal diseases and their pathological progression. This way, introductions have already been made and the physician performing the surgery knows the observer is well informed about the medical area. It’s a win-win situation.

What to Look for

A good observation not only tells a story, but also contains useful information that can lead to identifying opportunities. Observing just to watch a surgery is pointless. There has to be a goal or perspective for observations to be useful. Knowing what to look for gives that perspective, and helps the observer look at the environment in a different way. First though, the different tools used to capture observations need to be discussed because they play an important role in how an observation becomes an opportunity.

The standard toolkit for an observer contains the following: small notepad, pen or pencil, and a camera. Items such as an audio recorder or video camera may be added, but they are not necessary. The notepad and pen are crucial, as they will be used to write down every little detail that is seen or heard. The camera can be used to show situations and set-ups that are hard to describe in writing. Pictures also help down the road because additional observations can be made when looking back at them since something new could be spotted. These notes and pictures are the only documentation of the observations, so they have to be complete and readable for analysis afterwards. Using these tools to capture information does come with regulations that are outlined in the HIPAA policies mentioned earlier. The most important point to keep in mind is to be aware of the patient’s privacy. This means the patient’s name, face, or any other identifying information is never to be recorded on paper or in a picture. This can be tricky at times because the patient’s name and information is usually posted on several boards around the room and on computer screens. With pictures especially, an additional rule should be followed; always ask the medical staff permission to document and photograph during the observation. This is more of a common courtesy, but it is a good practice and helps gain respect and trust (a reoccurring theme).

Now that the tools for observation have been described, what is the most effective way to use them? This question gets back to the point made in the first paragraph of this section, and that is knowing what to look for. This does not mean that some observations are better than others, but having some structure to observing will increase the probability of identifying an opportunity. The first step to take is to do all the necessary background research around the domain. This includes reading current medical journal articles, looking at the devices now used in this space, and talking with physicians about contemporary treatment modalities. The research does not have to be extensive, just enough to become familiar with the landscape, and it is especially important for surgery observations so the observer understands what is going on and why. Having this basic knowledge will help put everything in context, and will eliminate a lot of the less fruitful observations.

This knowledge will also help frame the work-arounds, accommodations, or inefficiencies present within a given environment. These are what the observer should be looking for because these represent areas where the practioners have settled for something sub-optimal. Spotting these accommodations can be as easy as witnessing clinicians tripping over wires and tubes in the OR or less obvious once they have become second nature. An example of this is the observation of staff using a wet towel to secure the guidewire during an endovascular stent placement. At first this seemed insignificant, but after research and watching multiple procedures it became clear that keeping the guidewire in place was critical to the overall surgery. One slip of the wire could cause an additional 3 hours in the OR! In this case the wet towel is an accommodation because it is not the ideal solution. This situation led to an opportunity for device development around guidewire securement. Other work-arounds include: drawing on a computer screen with a marker, writing notes on hands, or using sticky notes on a piece of equipment to tell the user how to use it (all real examples). Situations like these are easily identified by the trained observer, but that does not mean they are noticed by others, and that is the beauty of observing the obvious.

Jeffrey Groom II and Jennifer Stovall belong to the University of Michigan Medical innovation Center.

 Image from Flickr user crucially.