2023 will be a year of regulatory challenges and change for medical device manufacturers and the patients who rely on them.
The rapid role of artificial intelligence and machine learning, combined with the surge in review submissions post-COVID-19 and rapid advances in surveillance technology and wearable sensors, is pushing digital health to the fore.
As such, the Food and Drug Administration must think of new ways to address device safety that are continually being updated or learned on the job.
In Europe, the European Commission is delaying the implementation of medical and extracorporeal device regulations, but many industry observers fear that they will not have sufficient capacity to review new and existing devices before the latest deadlines. I am afraid that
MedTech Dive asked industry observers in the medical technology sector for their take on the regulatory challenges facing the sector and regulators themselves in 2023.
said Andrew Fish, president and CEO of the Medical Device Innovation Consortium. FDA has several important challenges, including both its overall workload and the development of new regulatory approaches to better address evolving new technologies. When it comes to workloads, the COVID pandemic has brought its own challenges with the sheer number of applications for emergency use authorizations and related agency work. Agencies are now coming out of that crash, but must continue to meet the challenge of recruiting, training and retaining enough staff to stay on top of the application. The recent five-year Medical Device License Amendment reapproval is intended to set goals for agency review timelines and provide adequate funding to support the agency’s medical device review function. .
Working closely with the FDA as a member of a public-private partnership, much of our work at the Medical Device Innovation Consortium advances medical device regulatory science, improves the quality of device submissions, and accelerates review. We focus on making it. process by leveraging a modernized approach to evidence development. Such advances will make it easier for reviewers to efficiently and confidently assess safety and efficacy.
Another fundamental challenge is the pressure that evolving new technologies place on regulatory systems regarding how to assess the safety and effectiveness of devices in the context of the proliferation of devices that generate and utilize new capabilities and data. . For example, the FDA has been working on ways to regulate machine learning software in medical devices. This is because the FDA’s approach to regulatory review is rooted in his one-time approval of static, unchanging devices, often requiring new reviews for device changes. This is not a fast-moving approach and cannot easily address the huge potential benefits of machine learning in medical devices with fast-paced iterative improvements. This is an example of the agency’s challenge to regulate at the rate of innovation and maximize the potential of the medical technology revolution while providing safety and efficacy assurances and finding optimal outcomes for patients and public health. am. By bringing together regulators, manufacturers and a wide range of stakeholders to develop joint solutions that facilitate patient access to life-saving and quality-of-life improving medical technologies, MDIC is committed to supporting these types of research. Created to meet your challenges.
Rachel Sher, an attorney specializing in FDA regulations at Manatt, a Washington, DC-based legal and consulting firm, said: Congress said: FDA and medical product sponsors must make further progress toward their goal of ensuring better participation in clinical trials by a diverse and underserved population. it won’t work. The 2022 Food and Drug Reform Act (FDORA) introduces a new requirement that all medical device and drug marketing applications include a “diversity action plan” detailing how sponsors will achieve specific registration goals. established.
The COVID-19 pandemic has underscored the promise that decentralized clinical trials will help facilitate clinical trial participation by all patients. The continued success of the decentralized clinical trial model depends on better use of digital health technologies such as smart and wearable devices. As these technologies evolve, the FDA has taken steps to enable developers in this field to rapidly deliver products that meet FDA standards to patients and everyone involved in clinical trial undertakings. You should repeat the guidance you have issued.
Larissa D’Andrea, ResMed’s Vice President of Government Relations, Market Access and Clinical Affairs, said: 2023 is a pivotal year for digital health in the EU and US. In particular, how policies will affect the way digital health is prescribed, managed, and ultimately further adopted.
In the United States, the pandemic has fundamentally accelerated the use of telemedicine. For the benefit of our patients, we must build on that momentum through the creation of permanent digital/virtual care pathways that improve patient access and health.
The EU strongly supports the opportunity for consistency in data acquisition and use, and privacy regulation to protect patients and enable the use of digital health solutions.
We look forward to working with legislators, regulators, payers and commercial partners to advance this agenda on behalf of patients around the world.
David Kunz, Senior Vice President, Global Quality, Clinical and Regulatory Affairs, Zimmer Biomet, said: Our first focus for 2023 on the US/EU regulatory scope is: Continuing Evolution of the EU Medical Device Regulation (MDR) and Addressing Resource Constraints at Notified Bodies [the national testing firms or laboratories that certify medical devices in the EU]It also delves into supply chain challenges that are increasing the need for rapid product change approvals to avoid product supply shortages. Standard regulatory review timelines limit your response to supply chain challenges.
said Roz Burke, senior vice president of global quality and regulation at Boston Scientific. When we talk about patient safety in a regulatory context, we’re really talking about two things: ensuring that available devices and treatments are safe and effective, and the industry’s ability to save lives. To ensure that we can continue to develop new solutions to unmet clinical needs to help and improve. Quality of life. It is critical that industry and regulatory relationships prioritize both so that we can continue to make a meaningful difference in patients’ lives.
In the United States, the FDA’s willingness to consider new technologies and rethink traditional submission periods has allowed the industry to move more quickly toward better quality technologies. Machine-based automated inspections may offer more robust protection than human inspections for certain tasks, and FDA is considering how to reduce traditional review times given new technology as it becomes available. We have carefully considered whether to verify it and speed it up. We look forward to the continued evolution of these approval pathways to facilitate broader adoption of these technologies.
We are also optimistic about the agency’s commitment to agility, especially when it comes to software verification and digital health applications. A more agile approach to maintaining strong and effective surveillance while meeting the needs of patients and physicians in a diverse market is needed.
In Europe, we welcomed the recent publication of the European Commission’s proposal to amend the transitional arrangements in the EUMDR. We were well positioned to comply, but to handle costly implementation challenges that could prove prohibitive for many smaller players, as well as the influx of submissions. We recognize potential challenges to the medical device innovation ecosystem, such as the logistical hurdles of a small number of notified bodies. “
Agatha Anthony, vice president and head of global regulatory affairs at GE Healthcare, said:
In Europe, the most significant regulatory development in the medical device sector is the expected change in the implementation of the Medical Device Regulation (MDR). Concerns about the ability of Notified Bodies to handle a significant increase in demand for audits and certifications, and the potential for significant disruption to the availability of medical technologies on the European market, have prompted legislators to move the implementation date of the MDR back to 2024. We are considering a proposal to change from . Until 2027-2028, depending on device class. This is a promising development and, if adopted, will allow for a smooth transition to new requirements.
In the United States, recently passed comprehensive funding legislation expanded the FDA’s authority to implement requirements to ensure the cybersecurity of medical devices. This requires the agency to ensure that cybersecurity protections are included in new technology submitted after the law takes effect, and that manufacturers plan to control those devices and provide patches throughout the product lifecycle. You can check that you have
Another key trend relates to the rapid growth of devices powered by artificial intelligence and machine learning. The FDA has notified that a guidance document describing the use of algorithm change protocols is on his 2023 guidance priority list. This guidance describes the types of changes that can be implemented without the need to submit additional submissions under certain conditions. This will be an important development for innovative AI/ML technologies as it allows innovation to proceed at a faster pace while maintaining proper regulatory oversight.
Updated with comments from Andrew Fish, President and CEO, Medical Device Innovation Consortium
