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Getting Designers and Clinicians to Work Together on Medical Devices

Medical device engineers at Cincinnati-based Kaleidoscope have been living the dream for the past year through a partnership with Cincinnati Children's Hospital Medical Center.

Developers have occupied space amid the offices of the roughly 22 pediatric surgeons at Children's, collaborating closely with the doctors and others at the hospital to come up with device ideas and create them.

The initial focus has been with pediatric surgeons, but will soon spread to other groups at the hospital.

The intellectual property office at Children's is already reviewing some ideas that have come out of the collaboration, with some potential products becoming public next year. Products, for example, may include a simplification of the way anesthesiologists work in an operating room setting.

"We're very encouraged with the unmet needs that have been identified, and there are about a dozen that are being worked on. It's about being able to identify a lot of ideas very quickly," says Sean Barnett, MD, a pediatric surgeon who left Children's in August to become Kaleidoscope's chief medical officer.

Hear Kaleidoscope's Sean Barnett and Chris Hammond, discuss "Driving speed to market" at BIOMEDevice in San Jose, CA, December 3-5.

MPMN recently interviewed Barnett and Chris Hammond, director of insights and innovation at Kaleidoscope, about how medical device design works in this setting.

MPMN: So how did this all start?

Hammond: Kaleidoscope has been in business for almost 25 years. We were established in 1989. We've been working with big Fortune 100 companies for a long time. We definitely understand what it takes to bring a product to market, from early-stage needs identification, all the way to doing validation research. But one of the things that's always been a challenge, I think, is gaining access to clinicians. Sean and I met three or four years ago. There was a big movement in Cincinnati to create a [medical device consortium]. ... Sean, being on staff at Children's Hospital, represented the clinician side. ... As Sean and I got to know each other trying to get the consortium started, and as it became clear it wasn't going to survive, we started talking about serving the pediatric space, which is mostly unserved, and the ability to create this nimble team that's a collaboration between clinicians and people with product development experiences.

Barnett: When I surveyed my constituents, the physicians who were in our facility, the biggest complaint that I heard from them in regards to coming up with new ideas and new devices was that they didn't really have access to any of the engineers. They're busy. They're taking care of patients. They have these ideas, but they don't really have anyone to follow through with them.

MPMN: Why is this unique and interesting?

Hammond: Clinicians have a lot of ideas about how to make surgery smoother and work better, but there's really no mechanism. Most institutions really aren't set up to manage [the intellectual property] at all or what to do with it. I think a lot of clinicians feel like, 'I have an interesting idea, so that must be IP,' versus, 'I actually have a solution that's going to solve a problem.'

Barnett: We gave full access to the designers and engineers at Kaleidoscope. ... Not just the doctors, but all the nurses and pro techs involved. ... That's the point. It's meshing these two groups together to create a quick, easy, nimble team that can discuss different problems and talk the same language and come up with solutions fairly quickly.

MPMN: Why is it so hard for medical device designers to gain this type of access?

Barnett: [Physicians] have to be interested in talking with you. They have to know the whole point of why you're there. And they have to feel comfortable with you, too. Some physicians, they don't quite understand the whole intellectual property landscape. And they might come up with a problem that they think they have some intellectual property rights to it when there really isn't intellectual property there. What makes it easy for us is that Kaleidoscope and Children's have an agreement. So if we co-develop things, we share in the profits that come out of them as well. So it's a streamlined process. Everyone knows why they're there. It's not like anyone is going to come and steal anyone else's ideas. Even though I still think a good portion of physicians in that institution still don't quite understand how intellectual property works, they don't have that sort of fear because they know an agreement is in place.

Hammond: If I'm, say, Covidien, and I want to do something in the operating room, if I have surgeons that I don't have an established relationship with, that's hard. I'm Covidien, and I show up with a contract I'd like the surgeon to sign, the surgeon doesn't want to sign that because they're probably worried about some of their IP falling under that agreement. And there are sunshine laws, so we have to document how we pay some of these clinicians. If I'm a surgeon and I'm being approached by XYZ medical device company, is it worth my time and energy? I think what was unique about Children's Hospital was that it was really being driven by the clinicians, not by the tech transfer office, not by some quality improvement group. The win is clear on the clinicians' side: 'Now I have an outlet for my ideas and the things I observe.' The win on the designer/engineer side is, 'Now I have the clinician to vet my ideas against.'

MPMN: How does the setup at Children's work?

Hammond: Kaleidoscope's got a half a dozen people with batch access to the hospital. We can walk into any operating room at any day, any time and go and observe a procedure.

Barnett: The office wasn't staffed 24/7. But they had certain days when they were there in the office. And if we had a question we could go down to their office and talk with them pretty freely. They could also have access to us. We would go through the surgery schedule throughout the week, and if there were particular things that we thought were interesting to see or could be interesting, we would definitely make sure they would know the times for those surgeries, go over the surgical concepts initially before they came in so they knew what they were seeing when they came in. And there was hospital buy-in, too. The hospital had no trouble with them coming in, observing, and then taking it to the next level.

MPMN: Why the initial focus on pediatric surgery?

Barnett: During our training, we're trained as adult surgeons first, and we train at pediatrics after that for two years. The majority of people in a children's facility are just strictly trained as kids. We're trained on adults first, and then we train on kids. It gives us a different perspective. ... We have a better knowledge of the marketplace, especially from the operating room standpoint, than anybody else in that hospital because of the training we have.  ... Initially we just focused on the pediatric surgeons. There are 22 of them at Children's Hospital. There's a good number of them. ... The last thing I wanted was to have 200 people standing outside their door to try and talk with them, and then they would get nothing done.

MPMN: Any integration issues?

Barnett: Initially we did it as a pilot project just to see how it would work, make sure they could integrate into the hospital system. That really wasn't a problem. Our system is one where we're used to having a lot of visitors, especially a lot of international visitors, in our hospitals. When we first set this up, they had their own office right down the hallway from mine. They have an office that's in the set of offices of all the surgeons that are there.

MPMN: Do any other hospitals do this?

Hammond: As far as I'm aware, there's nothing else like this in the world. There are institutions that have innovation departments that are staffed with designers. I know the Mayo Clinic [in Rochester, MN] has got something. But I know some of the people who have worked there. Their projects are not self-initiated. When Kaleidoscope goes into the operating room, there's not one specific thing that we're looking for. We're just observing the entire procedure, and even pre-op and post-op, to look for unmet user needs. And not just user needs, really. The way we start our process is to identify a problem, and to provide some context to it, and from that problem define a solution-free user need. Especially for engineers and designers, it's very easy to see something, and then your knee-jerk reaction is, 'Oh, I know how to fix that.' As opposed to, 'How do we divorce a solution from the need?' From a brainstorm and ideation point of view, we can create a lot more ideas that way.

MPMN: What is a good example of this?

Hammond: I watched Sean replace a central line [kind of an IV into the chest] on a patient. To do that, they bring in ... basically a mobile X-ray machine. He's basically triangulating where this central line is in relation to the anatomy, so he can insert it back in. So here's [the operator of the machine], and here she's helping Sean and the staff to replace this line. Obviously, this is all digital imaging, and this stuff is all going to get uploaded to the system. The operator strings an ethernet cable from the device to the wall to upload the data. The cable doesn't even hit the ground. So I see this as, 'Hey, someone is going to trip over this if they're not careful.' And in fact, I watched people step over the ethernet cable so that no one would trip. So the need isn't, 'Hey we should make this wireless.' That would be a solution.

Typically, the anesthesiologist is going to have a number of different lines running to the patient in any given case. Especially in a laparoscopic case, you've got the scope, you've got all kinds of different cables. And when you look at it, it's kind of a rat's nest in the operating room. ... Saying, 'Hey, we need to get the cables off the patient,' that's more of a solution. Instead we need to recognize the problem as, 'Hey, there's an extreme amount of cables and connectivity in the operating room. How do we simplify that from a workflow point of view? And how do we simplify that from a safety point of view?'

MPMN: Could the solution be wireless?

Hammond: I've spent a lot of time in the wireless industry, so to me, it's, 'Hey, why doesn't this stuff go wireless?' But then if you talk to some of the clinical engineers, they say, 'I hate wireless. The hospital is a nightmare because so much is wireless, and I don't want to lose connectivity. ... If you think about big images, that's a lot of bandwidth.' From a clinical engineering point of view, the last thing they want to do is introduce another wireless device into the OR.

Barnett: So once the engineers would look at these and define them as problems, they would meet with me or one of my colleagues. We would really go over that problem, and say, 'This is truly a problem, or this is not.'' He watched me during this case, and there are cords all over the place.  But I don't ever notice any of this stuff because I'm focused on the patient when I come in the operating room. So it's a little bit different when they can show you a picture, and say, 'Well, there is this, this, and this that's in your way, and that's on the floor.' ... It really expedites the process and gets it moving faster.

MPMN: Why else is it useful to have designers on site?

Barnett: One of the good points with this collaboration that we didn't realize when we started is that we're able to identify all the stakeholders in the hospital. ...When I was at Children's Hospital, I was in charge of OR equipment standards. So any new products that came into the hospital came through my committee. There were people from purchasing, people from the storeroom, risk-management attorneys on that. Early on, the engineers realized that I may not be the primary customer of some of these devices. You've got nurses. You've got scrub techs. You have clinical engineering. I think that's one issue, that some people will design things for a physician and not talk to clinical engineering and say, 'We have this new Wi-Fi component that's going to solve all your problems.' And have them say, 'Well, we don't want Wi-Fi because we already have such a huge bandwidth problem at our institution as it is.' Just being able to figure out who the stakeholders are and being able to approach them, it just speeds up the process so much faster.

I go into the operating room when the patient is getting ready to be operated on, but there's a whole bunch of stuff that happens before that I don't even know about.

MPMN: Any surprises along the way?

Hammond: Some of the stuff that the designers and engineers get really excited about ... Sean and his colleagues, they were like, 'Hey, we only do 20 cases. It's only got a pediatric application.' While the ones we continue to pursue, while there's a strong pediatric drive behind that, we're also looking at the bigger market. Historically, pediatric devices get pushed down from the adult market, if at all. Can we create designs and solutions in the pediatric market that can trickle up from the adult market?

MPMN: Give me an example. What was something the designers were interested in, but was parked for now?

Barnett: There's a chest deformity called pectus excavatum. It's like a scooped out chest. The way we fix that is we actually go through the chest, we put a bar in that is precurved around the chest, and we actually flip it so that it from the inside out pushes the chest in the position where it needs to be. The problem is that we have to go in two to three years later and take the bars out. And there's not a good way to create a bar that's absorbable so we don't have to remove those bars later on in the process. ... If you're talking about a new device that is a better way to do a breast biopsy, there's a huge market for that. ... But if you're talking a procedure that's performed only 20,000 to 40,000 a year at most, then it's hard to have people fund it and put a lot of dollars into it to come up with new solutions.

We really looked at things that we could work on initially that were easy products, that were quick gains, that didn't have to go through a lot of the FDA process so we can get things to the market to really validate our process first. Some of these higher-level things that are going to take more time and more money, we've kept them aside.

Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker.

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