Are medical device makers doing enough to account for patient demographics?

Innovative medical devices have the potential to help people from all different backgrounds and walks of life. However, regulators and medical experts have raised concerns that firms are not doing enough to take into account the needs of certain populations when testing new products. A study conducted by researchers at Yale and the University of California-San Francisco found premarket trials for medical devices commonly lacked robust demographic information.

Manufacturers can address these issues by taking proactive steps to consider the needs of different groups of patients. In fact, accounting for the patient experience during the medical device design process and premarket testing may present exciting new opportunities. A growing emphasis on patient-centered care and engineering points the way forward for new medical products.

The FDA on patient demographics

The Food and Drug Administration Safety and Innovation Act, which was signed into law in July 2012, served to bolster the FDA’s authority in handling various aspects of public health. While other parts of the law addressed user fees and encouraged breakthrough therapies (later built on by the 21st Century Cures Act), Section 907 required the agency to develop a strategy for expanding the inclusion of diverse populations in the premarket trials of medical products.

A report from the FDA working group tasked with researching the issue pointed out that tailoring treatment to suit the needs of individuals is a major goal for medical product development. Working toward that outcome calls for involving diverse populations in the testing of new treatments and devices as much as possible. Nonetheless, the group found in examining 72 applications submitted in 2011 that racial minorities were underrepresented in trials.

The FDA’s 2014 action plan laid out three priority areas:

• • Gathering demographic subgroup data that is more complete and of higher quality

  • Discovering what barriers keep particular subgroups from participating in clinical trials and finding the means to get a more diverse range of people involved.

  • Making the relevant demographic subgroup data more transparent for the public.

  Insufficient analysis in premarket studies

  The new study, published as a research letter in JAMA Internal Medicine, suggested there is still work to be done in gathering high-quality demographic information about subjects in premarket trials for medical devices, and making adjustments accordingly. Researchers examined 82 studies filed in 2015 to find out whether particular groups of patients are being overlooked. They found that, in many cases, the question of demographics is going largely unaddressed by medical device firms.

  Among the studies reviewed by the researchers, only 9 percent had been analyzed according to age, and 4 percent by race. Meanwhile 17 percent of the 77 studies that involved both men and women were analyzed by sex. Based on the information provided in the studies, it was often difficult whether the approach to demographics involved any statistical tests or analyses, which could make the difference in their clinical relevance.

  Lead author Dr. Sanket S. Dhruva, a postdoctoral fellow at Yale School of Medicine, commented on the significance of the findings to Yale News.

  “We know that women, the elderly, and minorities have been underrepresented in clinical trials for drugs and treatments of many diseases and conditions,” Dhruva said. “Our new study shows how these important patient groups are also being overlooked in the evaluation of medical devices.”

  Accounting for factors like age and race could make medical devices more effective.

  Exploring innovative ways to meet the needs of patients

  Accounting for demographics adds another wrinkle to the process of gaining premarket approval, but these considerations may have a vital role in determining the future growth of the firms developing and marketing new medical products. For instance, according to the U.S. Census Bureau, extended life spans and improved treatment options will result in a world population that includes about 1 billion people over the age of 65 by 2030. An aging population that is living longer than ever leads to greater demand for treatment, but it’s important to understand thoroughly how the effectiveness of a new product might be affected by age and interactions with other conditions among seniors.

  Other factors like gender and genetics may also have major impacts on the outcomes for using certain devices. Having as much demographic information as possible tied to clinical trials might deliver long-term benefits for manufacturers as they strive to create products to meet individualized requirements, making the user experience as straightforward and comfortable as possible. Deeper insights into patients can drive smart choices in medical interface design, creating an appealing visual brand language.

  The FDA and researchers are making the case for improving results in using medical devices by accounting for diverse populations. For makers of medical products, following this guidance may also lead to new opportunities. Patient-centered care that grants individuals more agency in their own treatment is the wave of the future, and tailoring function and design choices to meet diverse needs provides a leg up.

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