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Abbott, Illumina, other medtechs shape guide conveying device risks to patients.

The Medical Device Innovation Consortium (MDIC), a public-private partnership with a focus on regulatory science, has published an overview of best practices for improving communication with patients during the treatment decision-making process.

MDIC on Friday said the report is part of a larger movement to integrate the patient's voice in areas that include device design, clinical development and regulatory review. The report's authors include representatives from Providence St. Joseph Health, Abbott, RTI Health Solutions, NSF International, Versant Ventures, Illumina, the Arthritis Foundation and consultant WSCollaborative.

The partnership's latest initiative, aimed at fostering more effective communication with patients, reflects a broader push by FDA to include the patient perspective in the medical device regulation process. FDA in August released draft guidance on how to collect data from patients that can be used in clinical studies, device development, evaluation and labeling.

MDIC, a collaboration between FDA, the National Institutes of Health, CMS, industry, non-profits and patient organizations, was formed in 2012 to improve the processes used in the development, assessment and review of medical devices. It also established the National Evaluation System for health Technology Coordinating Center, or NESTcc, which operates an initiative to evaluate real-world evidence (RWE) from clinical registries, billing claims, electronic health records and other sources to assess the performance of medical devices.

In its report, MDIC said communications about the risks, benefits and uncertainties associated with the use of medical devices may come into play when ensuring informed consent for clinical trial participants or developing the content of a product label for a commercially available device. Other situations may involve discussions among providers and patients at the point of care, or for notification of a recall or changes made to a device. Communications may occur in non-clinical settings such as on social media platforms or within patient advocacy groups.

The report notes that the trend toward shared decision making between patients and clinicians creates the opportunity for device manufacturers to communicate benefit, risk and uncertainty information about their products. The National Quality Forum, which has advocated for shared decision-making to become the standard of care for all patients, stresses the importance of communicating clear, accurate and unbiased medical evidence about treatment options, including no intervention, and the risks and benefits of each, MDIC said.

The paper also identifies characteristics of providers that can help improve communication of risk and benefits to patients, and challenges patients face in understanding health information. It includes several case studies that illustrate effective communication strategies.

A pair of upcoming meetings may help further the conversation. FDA plans to conduct a workshop on Sept. 30 to discuss patient input into device evaluation. Called "Patient-Reported Outcomes (PROs) and Medical Device Evaluation: From Conception to Implementation," the meeting will look at the benefits and challenges of incorporating the patient voice in regulatory decision making. MDIC will host a webinar on communicating benefit, risk and uncertainty for medical devices on Oct. 2.

Author:Susan Kelly


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