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August 2015


The patient's voice will be heard. Clinical evidence and documented patient outcomes may represent the Holy Grail for developers -- and buyers -- of new medical technologies. But in an age of patient-centered medicine, is it any wonder the patient's voice is getting louder in the development and acceptance of new technologies?

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Nashville, Tenn., is the site for the 2016 IMDA Annual Conference & Manufacturers Forum, May 1-3.
Nashville, Tenn., is the site for the 2016 IMDA Annual Conference & Manufacturers Forum, May 1-3.

The patient's voice will be heard...
Patient preference is being built into the FDA review process

Clinical evidence and documented patient outcomes may represent the Holy Grail for developers -- and buyers -- of new medical technologies. But in an age of patient-centered medicine, is it any wonder the patient's voice is getting louder in the development and acceptance of new technologies?

Since 2012, the U.S. Food and Drug Administration has urged manufacturers and developers of medical technology to factor in patients' perceptions and tolerance of the risks and benefits of new technology. Earlier this year, the agency issued proposed guidelines to help manufacturers collect and measure patients' perceptions in a meaningful, usable way.

The guidance document ("Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications"), which was issued in May 2015, makes it clear that submission of patient preference information is voluntary on the part of medical device manufacturers and developers. That said, the agency clearly believes considering patient perception is critical in the pre-market (and postmarket) phase of the product lifecycle.

"The Agency understands that patients and caregivers who live with a disease or condition on a daily basis and utilize devices in their care may have developed their own insights and perspectives on the benefits and risks of devices under PMA, HDE, or de novo review," writes the FDA in the document. "FDA believes that patients can and should bring their own experiences to bear in helping the Agency evaluate the benefit-risk profile of certain devices. This kind of input can be important to consider during regulatory decision-making for certain devices."

"Talking about assessing patient preferences isn't necessarily new," says Stephanie Christopher, program manager, patient centered benefit-risk assessment and clinical trials innovation and reform, Medical Device Innovation Consortium. "But using [patient preferences] in a regulatory context is fairly new."

MDIC is a non-profit public-private partnership that operates in partnership with the FDA, medical device industry and non-profits to improve the medical technology regulatory environment. With a steering committee of member organization and FDA representatives, patient advocates, and other experts, MDIC published its "Framework for Patient-Centered Benefit-Risk Assessment" around the same time that the FDA released its guidance document.

"The FDA guidance is saying, 'we want to understand the patient's perspective on possible benefits and risks of the devices we review.'"

For years, manufacturers -- through their marketing departments -- have solicited comments and preferences from physicians and other users about their products, such as the ease of use, Christopher points out. What's new is trying to determine how patient perspectives can be gathered, analyzed and quantified, and thus offer scientifically valid information for regulatory reviewers, she says. "If we are going to include this information in regulatory submissions to FDA, they're only interested in data that's rigorous and meaningful."

Safety and effectiveness still No. 1

Patient preference information does not change the basic standards of safety and effectiveness, points out Christopher. In other words, the FDA won't approve a device that isn't safe or doesn't work, regardless of patient perspectives. But patient-preference information gives "additional information on risks that patients might be willing to tolerate in exchange for benefits," she says. "Prior to this move to include patient preference, the benefit-risk assessment was done from the perspective of physicians, clinicians and reviewers. The FDA guidance is saying, the safety and efficacy doesn't change; but when we're doing benefit-risk assessments, we want to understand the patient's perspective on possible benefits and risks of the devices we review."

Such input is valuable. "Patients understand the reality of living with a disease," says Christopher. "They understand their symptoms and how they impact their life, and they understand what it would mean to have some alleviation of symptoms or a disease state, and what risk they might be willing to tolerate for that."

The MDIC Framework points to an FDA study in the area of obesity, where the FDA's Center for Devices and Radiological Health had undertaken a patient preference study with obese patients who were asked about several different attributes of potential weight loss medical devices. The patient preference study led to the development of a decision aid tool available to reviewers who were reviewing new obesity medical devices. The January 2015 marketing clearance for the Maestro Rechargeable System (EnteroMedics, St. Paul, Minn.) for certain obese adults, which targets the nerve pathway between the brain and the stomach that controls feelings of hunger and fullness, was based in part on patient preference information from the CDRH study.

Quantifying patients' perspectives isn't easy, of course. Hence the FDA's lengthy draft guidance document. Doing so becomes even trickier before a new device is on the market. "We are often asking patients about hypotheticals," says Christopher. "It can be a difficult thing if they're not familiar with what the symptoms will be like [with the new device vs. existing ones].

Future

"The field of patient preference is still relatively nascent," she says. "One area for future research -- which we talk about in our Framework document -- is looking at what patients would prefer before they have experience with a particular technology, and seeing if those preferences are consistent with choices made by patients who have experience with that technology."

Though it's difficult to predict the future, the patient-centeredness movement has grown in the past several years, and shows no sign of slowing down, says Christopher. "Patients have found ways to collectively organize and make their voice heard," she says. "One way they are doing so is directly with the FDA, and the drug and medical device companies. It's yet to be seen how often patient-preference information will be used [in the regulatory environment], but there certainly is a lot of interest for any number of reasons.

IMDA Announcement

July 510(k)s

View a list of all medical devices that received FDA 510(k) marketing clearance in July by visiting the FDA website.

You might find a company who needs your expertise."

"We want to engage patients. But this is also an access issue. We are showing that there are patients who want access to new technologies, and who understand the risks and benefits. We'll see where it is applied."

Editor's note: Click here to access the FDA guidance document, "Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications."

Click here to access the MDIC "Framework for Patient-Centered Benefit-Risk Assessment."
 

Why listen to the patient?

Here are three reasons why patients' perceptions of the benefits and risks of medical technologies can be useful to FDA reviewers, according to the Medical Device Innovation Consortium:

  • Framing benefit-risk issues. Patient preference information can help identify the key benefit-risk issues of a particular therapy and how patients trade off benefits and risks of the therapy.

  • Identifying subgroups of patients that would prefer a technology under review. Patient preference information can be helpful to identify subgroups of patients with decision-relevant differences in preferences, particularly those subgroups who would be willing to accept the currently known benefit-risk tradeoffs of the technology under study.

  • Building a quantitative benefit-risk assessment model. Patient preference information is essential to bring the patient's perspective into cases where a quantitative benefit-risk model is used to inform a product approval decision.

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2015-2016 IMDA Board of Directors

President
Don Sizemore, D&D Medical (615) 859-2337

Past-President
Hal Freehling, O.E. Meyer Company (419) 609-6133

Secretary/Treasurer
Don Reiter, SRC Medical (818) 717-8807 x19

Chairman of the Board
Duke Johns, Medical Specialties, Inc. (504) 734-1171

Directors-at-Large
Bill Carmouche, Medical Dynamics (916) 624-3952
Todd Endersby, Alamo Scientific (210) 543-1300
John Marmo, Martab Medical (201) 512-1100
Griff Overturf, CoMedical, Inc. (206) 524-7424

Manufacturer Representatives to Board
Robert Messer, Maxtec, Inc. (615) 512-4093

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