Jamie Hartford

The task of making medical devices today may be harder than ever before. It’s no longer enough for designers and engineers to simply focus on innovation. They also have to find ways to prove that their devices improve patient outcomes or, at the very least, reduce costs

In this cost-conscious environment, providers are growing increasingly picky when it comes to the technologies they embrace. To find out what it takes to get your device into the hands of physicians, we went right to the source. MD+DI interviewed eight physicians about what it takes for a medical device to succeed in the market today. Here’s what we learned.

What Makes a Medical Device a Game Changer?

It’s every medical device designer’s dream to disrupt the standard of care, but how do you actually achieve that? One way is to bring down the size, cost, and complexity of tools necessary to improve diagnoses and treatments.

For an example of a device that fits that bill, look no further than portable ultrasound, which several of the physicians we queried cite as a medical device that has transformed the way they practice medicine over the past five years.

By turning this once expensive, cumbersome, and complex technology into an affordable, portable, and easy-to-use tool that can guide care in numerous settings, manufacturers have truly disrupted medicine as usual, they say.

“Now ultrasound technology can be much more broadly applied and with that people are able to expand its uses,” says Sumanth Ambur, MD, an emergency medicine physician and critical-care fellow at Hennepin County Medical Center in Minneapolis.

Ultrasound machines are now in every intensive-care unit and emergency department, says Thomas Granchi, MD, director of the Burn Treatment Center and clinical professor of surgery at the University of Iowa (Iowa City, IA).

“The students and residents are growing up with them and expanding the indications. I think it will eventually replace the stethoscope in the pockets of every med student and resident,” he says. “Bedside ultrasound is changing the way we practice critical care.”

Maneesh Amancharla, MD, an anesthesiologist and partner at Capitol Anesthesiology Association in Austin, TX, says portable ultrasound helps him improve accuracy and reduce complications in tricky nerve-block procedures, and he appreciates that the machines have been stripped down, simplified and customized for different specialties.

“For probably decades, the machines were designed by engineers, but you could tell that they showed off the functionality of the technology and that was a beautiful thing and a wonderful thing, but it probably made them more confusing to use, and I think it was an impediment to the full adoption of the technology,” he says. “Today, I use a machine that’s targeted for me. Its functionality is limited to those things that I want to do, and that, I think, has markedly increased the usability.”

How Can You Get Your Device on the Shelf?

It’s no secret that purchasing in healthcare is in the midst of a dramatic shift. From hospital value analysis committees to physicians in private practice who have to keep a keen eye on costs, the path to getting your device on the shelf is longer and more winding than ever before. It’s no longer as simple as adding a few bells and whistles to your product and waiting for the cash to roll in.

“There’s a lot of paperwork and a lot of begging and pleading it takes for us to get new technology on the shelf,” says William Cohn, MD, a cardiovascular surgeon and director of the Center for Technology and Innovation at the Texas Heart Institute in Houston. “The hospital’s very focused on the bottom line . . . they really want to see an economic argument of why it's better, and that usually has to do with better results, better safety, avoiding complications, and things like that.”

Cohn says there’s also a move to decrease the number of SKUs hospitals carry.

“Some of the big hospitals say you’ve got eight different guys that are using eight different heart valves, we’re only going to stock two, so you guys have to decide which ones they are and we’re going to go to industry and see what kind of deal we can get from the companies if we say that we’re going to use just their valve,” he says.

Granchi tells a similar story.

“As the medical director of a burn unit, I have some influence in the evaluation and selection of items for capital purchase, but I don’t get my entire shopping list,” he says. “New devices must be vetted by committee, and requests for capital items must be submitted up the corporate hierarchy. I must justify the capital expense before the hospital buys the device.”

Although a common refrain in the healthcare industry is that physicians no longer hold the clout they once had when it comes to purchasing medical devices, the physicians we spoke with say they still have a lot of pull. But, unlike in the past, they’re not the only ones at the table.

“We physicians are now more involved with the hospital systems regarding new device purchasing decisions and evaluation of current devices for cost-benefit analyses,” explains Lyssa Ochoa, MD, a vascular surgeon in San Antonio, TX. “We are able to review more data with the hospitals to help us all in discussing which products best serve our patient population and minimize costs.”

And although many physicians are increasingly employed by hospitals, private practices still exist, and the economics of appealing to them are slightly different.

Take this example that Amancharla, who works for a large anesthesia group practice, offers up about video laryngoscopes, which can help to intubate patients with difficult airways more safely.

“Hitherto, that technology has been expensive, hospital-acquired, and hospital-based,” he says.

But there is a movement toward caring for patients outside a hospital’s walls, in places like surgery centers and office-based settings. These facilities, he says, don’t always have the funding or the volume to justify purchasing that kind of equipment.

“But we’re seeing video laryngoscopes shrink down to pocket size on one hand, and their cost is approaching the range where an individual physician, such as myself, can now purchase this, keep it in my bag everywhere I travel, and use it in emergency situations, whether in a small surgery center or in an individual physician office,” he says.

In developing a novel product, device makers need to keep in mind that physicians, too, have a bottom line.

“While their mission is to help people, physicians still operate a business,” says Robert Sambursky, MD, a cornea specialist with Manatee Sarasota Eye Clinic and Laser Center in Sarasota, FL.

“It does not matter how good the technology or clinical benefits; if the physician cannot cover their costs, they will not [buy] any new devices,” he says, adding that they also need to consider reimbursement. “Investigating both Medicare and third-party reimbursement rates prior to implementing routine use is required for any new device to become part of the protocol of a medical practice.”

What Will It Take for a Device to Succeed Today?

As the healthcare system shifts from a fee-for-service model to one that rewards value, physicians are being forced to change the way they practice. Device makers, too, need to adapt in order to keep up.

Products that succeed in this new reality, physicians say, will need to offer cost benefits over their predecessors.

“If we can’t do it cheaper with this device, we’re not going to do it,” Ambur says.

But that doesn’t mean expensive devices are dead on arrival.

“Technologies can be very costly if the costs are justified,” Cohn explains.

Although, devices with a higher price tag must be able to withstand increased scrutiny.

“Every device or every therapeutic or every biologic that we embrace, if we want to get it into a hospital, we have to make a compelling argument that it’s going to add value to what we do, so make it safer, faster, decrease redundancy, improve results,” Cohn says.

Improving quality and efficiency are also high on the agenda.

“Any device which does not improve outcomes compared to established devices or technologies, or the price of achieving these outcomes, or the quality or efficiency of a practice is a device searching for an application,” says Howard Green, MD, FAAD, a dermatologist in Palm Beach, FL.

And it’s not enough to for manufacturers to simply say their device can accomplish these things. They have to be able to prove it.

“Having clear scientific evidence for their efficacy is key to putting a value to any device,” Ochoa says. “If device manufacturers are able to quantify case-based cost savings compared to existing devices and include efficacy in such an analysis, more hospitals and physicians will be willing to use the new devices in a value-based healthcare system.”

It’s not just about proving your case to physicians either.

“Anything we can do to increase patient satisfaction . . . is certainly more likely to succeed,” Amancharla says, citing elastomeric pumps, which enable him to send patients home and control their pain remotely after a procedure, as an example.

“We’re moving patients into an outpatient setting and doing a better job of controlling their pain and increasing satisfaction, and again something like that is more likely to succeed,” he says.

How Do You Design for the User?

To bridge the divide between the way medical devices are designed to be used and how they are actually used, the physicians we queried were largely united in their advice: Ask us.

“I believe having real-life experience with the needs of the device user is key,” Ochoa says, adding that it’s also important to involve physician users early in the process.

“I think oftentimes you see products come out that have that gone through engineering, have gone through several generations of prototypes, and then they come out and say, ‘Hey doc, what do you think about this?’” Amancharla says. “Sometimes that’s too late. You’ve got to design with the physician-user in mind and get that input early.”

He continues, “I would make the analogy of designing for regulation. Engineers very much get that they have to design with regulatory standards in mind from the very beginning, and I want to see that kind of attitude toward design with the clinical end user in mind from the very early stages as well.”

But Cohn emphasizes that simply checking the box of getting user input isn’t enough.

“You can ask questions and you can put focus groups together, but it behooves you as a medical device company and as an innovator to ask the right question and ask it of the right people,” he says. “If you ask the wrong people or ask the wrong question, then you go down the wrong path.”

He uses the example of a device that allowed cardiologists to attach two blood vessels together during coronary artery bypass to prove the point.

“You could take a vein and load it up on this device and then thread it into the coronary artery and pull the trigger and it hooked the two together, and it allowed you to do coronary artery bypass without having to put the stitches in,” he says. “But what [the company] didn’t realize was that that’s the part of coronary bypass that heart surgeons enjoy doing and take pride in doing.”

He compares the device to a paintbrush for artists that could be pointed at a subject and then simply pointed at a canvas to create a work of art.

“We’re not looking for technology to do the part that we like to do; we’re looking for technology to do the parts that we don’t like to do, or that are difficult to do, or that cause complications,” Cohn says.

One way for companies to get meaningful feedback is to talk to physicians with a lot of experience in the particular procedure or treatment they’re designing for, says Marlon Guerrero, MD, director of endocrine surgery and assistant professor of surgery at the University of Arizona (Tucson, AZ).

“. . . Identify high-volume surgeons, either locally where the manufacturer is located or nationally, and go and get input from physicians during surgery,” he says. “And these surgeons may not necessarily be at academic centers. Sometimes private practice physicians have higher volumes, but manufacturers should go to high-volume centers to get inputs on little tweaks on how to make these devices easier to use."

But no matter how much user input engineers and designers get, in the end, it may not matter.

“Designers and manufacturers lose control of a device when the user puts [their] hands on,” Granchi says. “Intended uses are only suggestions.”

And that’s not necessarily a bad thing. Sometimes, that loss of control can lead to innovation.

“Imaginative users, who know the clinical problems, may ask themselves, ‘I wonder if I can use this for x problem?’” Granchi says. “Some experimentation ensues, and a journal article may appear. The new use may enter common practice. If the market is large enough, the manufacturer may redesign and market a new device for the new indication.“

Jamie Hartford is the editor-in-chief of MD+DI. Reach her at [email protected]. Reach her at [email protected] or on Twitter @MedTechJamie.

MD+DI senior editor Arundhati Parmar and Stephanie Kreml, MD, principal at Popper and Co. and a member of MD+DI’s editorial advisory board, also conducted interviews for this story. 

[image courtesy of STOCKIMAGES/FREEDIGITALPHOTOS.NET]