MD+DI managing editor Brian Buntz recently had the chance to speak with Mary Beth Privitera a designer of medical devices and biomedical-engineering professor at the University of Cincinnati who oversaw the Medical Design Excellence Awards judging process in 2011. In the first part of a two-part interview (the second part is available here), Privitera spoke on clinical observation in medical device design.
MD+DI: We were interested in what we’ve heard referred to as the “human element of innovation.” What does that mean to you?
Mary Beth Privitera: Well, “human element” means multiple things to me. Because at every part of the process, there’s that element: from generating an idea, being around the right circumstances to get the need acknowledged to design a product around, all the way through having to make decisions to distill the ideas down to make the final device fit the actual market or people you are trying to design for. Most of the people you are designing for are not physicians unless you are doing participatory design.
|The above image is a display of catheter interaction area. It is drawn from a forthcoming book titled Mapping Clinical Procedures that includes a chapter co-written by Privitera.|
The human element is the one common thread that is throughout the entire process and throughout the entire innovation cycle where you get the idea, the inspiration for the idea, and then there is a whole push from a regulatory perspective of making products that are more advanced with regard to ergonomics and human factors. A new device might come out to market and it may be successful clinically but may be very difficult to use and therefore fail.
MD+DI: In your view, what role does participatory design play in the medical device space?
Privitera:I think it is very, very common. Almost all medical device companies rely on the physician to be a key opinion leader and to guide them throughout the process. When you talk about invention and innovation, it’s usually a very small team behind the original concept. It might be one engineer and one physician, the problem owner working with the problem solver. And there’s a difference between the problem owner and the problem solver. The problem solver really can’t solve the problem effectively unless they have good knowledge and a great appreciation and understanding of the problem owner and vice versa. Typically this is truly a back and forth between a physician and an engineer. Of course, some people have both medical and engineering degrees. Most of those people, however, are forced to choose between one of the two careers and make either medicine or engineering their full time job.
“The problem solver really can’t solve the problem effectively unless they have good knowledge and a great appreciation and understanding of the problem owner.”
Usually, participatory design means that you have the problem owner sitting at the table while you are trying to solve the problem. In our program [at the University of Cincinnatti], we do that repeatedly and involve the physician along the way with the hope that the solution that we develop better meets the context in which the device is going to live.
MD+DI: I’ve heard that physicians often can become so focused on the minutia of work that they sometimes can lose track of the context of their work and the possibility that the workflow could be optimized. How are such problems or inefficiencies typically recognized?
Privitera: I can give you an example of that. We do these deep dives—ethnographic approaches—where we’ll go in and we’ll observe care and then we’ll do visual maps of the care and then figure out what is important to measure in terms of the efficiencies and inefficiencies. In developing these visual procedure maps we present the use of materials, tools, and tasks within this context, you can analyze what is really a bother and what is not a bother, or what takes an exorbitant amount of time.
An example is a recent research study on just simply following diagnostic neuro-angiograms. In this study, we discovered that clinicians were spending upwards of about 30 minutes to make sure there were no bubbles whatsoever in their lines. And that is a very good thing because the lines are going straight into the the femoral artery traversing to the brain, any amount of air can be an embolus. And that would obviously be a bad outcome.
When we brought this to the attention of those attending, they hadn’t realized the extent of time they were spending doing this menial task. But sometimes they have to do things like that because there is no alternative.
Another example would be just simple inefficiencies in terms of body position and how the devices interact and how many connections you need to make. Many procedures are very complex and they require multiple tools and many tools have to be used in a given sequence within a procedure. The tool design in and of itself has to respond to the order in which the procedure is done. So all of those complicating factors as a result of the product design makes the clinical procedure that much more complicated, which results in one of two actions happening: the physician could be jazzed because it is so complex; many physicians will say ‘you know what, this is a really hard procedure and that is why I go to my job every day because it is a challenge that I look forward to.’ The other possibility is that they say ‘that is too difficult and not worth the effort—I’m not going to practice medicine like that.’
|This table is a component of a training procedure map, which also was drawn from the book Mapping Clinical Procedures.
It’s important that when you look at all the visual mapping of procedures and/or ethnographic data that you capture the opinions of whether it is good or bad—because stress and time may not necessarily be bad or good. Sometimes, a certain amount of stress can be good. For instance, careful preparation often takes a lot of time and costs a lot of money but it can also save lives.
MD+DI: We recently ran a piece on clinical observation. This is a topic that you seem to be well versed on. Do you have any advice to offer on how to get the most out of it?
Privitera: Device designers should do as much clinical observation as they can afford to do. You can never really have too much. There’s a point at which repeated patterns become noticeable through observation. Doing a broad study of different geographic areas can be helpful. There are other elements to consider as well: is it a teaching hospital or a private hospital? Is the procedure performed by a novice or an expert? You really have to consider what you are looking at in terms of who the users are to determine how much observation is enough. Certainly none is not enough. But it may be that you only need to observe five procedures when you are talking about a practice of medicine that is very regular and regimented, although those are not very prevalent. But if you can start seeing a pattern in the procedures, then you have probably done enough.
As for how you elicit the pain points or the things that care providers would be willing to change, that can come in two ways.
One would be to simply observe the inefficiencies or face grimaces. I know that some people have tried to use monitor the surgeon in someway to measure their stress level. We’ve talked about this in our own hospital. We’ve discussed measuring their stress load via heart rate, temperature, and by looking at other physiological parameters like you would monitor an astronaut as these parameters are often indicators of stress: elevated hear rate and so forth. The challenge you have with those is that they give you a measure but you are not really sure what it means. This goes back to the point that surgeons do a difficult job and that’s why they come to work in the first place—that motivates them and we want them to be there to be brave enough to do some of the tasks that they do.
That leads me to the second way to identify pain points: You need to ask physicians where those points during the procedure are that challenging for them and how they feel about them. Do they feel that they are too difficult? Could it be easier? What, if they could have a clean slate and do it all over again, would be the ideal? It can be helpful to have them paint that picture. Without that directed opinion, it’s hard to understand any kind of objective measure.