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Market access for medical device and diagnostics manufacturers is more difficult than ever. New global compliance requirements and payer demands for more detailed information compel companies to be as good at communicating the value and safety of their products as they are at developing them.
In Europe, the new Medical Device Regulations (MDR) will soon require medical device and diagnostics companies to provide stronger clinical evidence on the efficacy, safety, and net worth of their products—a notable change to the basic requirements of the past. In addition, data requirements for market access vary country-by-country. For example, cost savings is of highest importance in Brazil and Italy, whereas cost effectiveness is of greatest importance in the United Kingdom and France.1
In the United States, FDA released more than a dozen new device guidance documents in 2016 and 2017 that set new expectations for risk assessment. FDA also implemented a Breakthrough Devices Program in 2018 that streamlines market clearance and approval of certain medical devices, but it requires manufacturers to capture and submit very detailed information on their devices and explain how they meet program criteria.2
The Affordable Care Act, too, now demands specific details that go beyond simple explanations of how a new device works to increase the accountability and quality of patient outcomes. Now, manufacturers must generate clinical data to explain potential side effects, costs, invasiveness compared with alternative treatments, pain levels, when and how to use the product, plus other real-world data that demonstrates product value not just product efficacy.
In addition to new regulatory requirements in both the European Union and the United States, medical device and diagnostics companies are facing greater demands from other stakeholders. They must provide broader, more value-based data to obtain coverage from payers and satisfy inquiries from budget-conscious public healthcare systems looking more holistically at the long-term benefits of a device on patient care.
While these changes may be useful in lowering the overall cost of delivering healthcare, they add a significant burden on medical device and diagnostics companies when bringing innovative products to market. To succeed in this new environment, manufacturers will need to better communicate product value in addition to safety.
Addressing the Concerns of More Diverse Stakeholders
Over the past three decades, device companies only needed strong clinical evidence that a product performs as described and provides a clinical benefit to the intended patient population. Now, they must provide additional data points to address the interests of a wider group of stakeholders, including regulators, payers, providers, hospitals, hospital networks, patients, and advocacy groups. So in addition to sharing product safety and efficacy evidence, companies must show health economic information that demonstrates product value to all of these groups—each of which may define value differently.
For example, national hospital networks, which often buy devices in bulk, want to know the value of using new products or procedures before making a large investment. Medical device and diagnostics manufacturers, therefore, must provide meaningful information beyond statistical outcome, such as findings on the long-term benefits of a new or improved product to the healthcare system as well as the patient. More than offering explanations of a product’s intended purpose, manufacturers must outline product value, long-term cost savings, length of patient recovery, and more to help healthcare decision-makers determine the products that will provide the best patient care within their budgets.
The same is true for payers, which typically have the greatest influence on market access. In the past, a CPT code plus coverage meant reimbursement. However, a CPT code no longer equates to automatic reimbursement from insurers. Today, medical device and diagnostics companies must show proof of its long-term value to stakeholders. They must present clinical data and real-world evidence that while their product may be more expensive than a current product or treatment, it will save money over time given a shortened hospital stay, elimination of a secondary procedure, or other benefits.
“Insurance providers, both private and public, are no longer relying solely on the opinions of medical experts or clinical trial data to make coverage decisions. They are increasingly looking at cost effectiveness as the gating factor for payment,” explained Shantanu Gaur, M.D., co-founder and chief scientific officer at Allurion Technologies, a medical device company, in an article for STAT NEWS.3
Defining the Right Endpoints without Defined Standards
While manufacturers generally understand the regulatory data requirements when introducing a new investigational or re-purposed technology to market, no standards exist for information required by other stakeholders as each uses their own metrics to evaluate a device. The Professional Society for Health Economics and Outcomes Research (ISPOR) offers some best practices for outcomes research and its use in healthcare decision making, but no universal guidelines exist standardizing the economic endpoints that should be captured during every study—further complicating market access.
In order to overcome all of these obstacles, medical device and diagnostics companies can take the following three steps:
1. Plan Ahead for Clinical Studies
It’s more important than ever for companies to take a preemptive, holistic approach to clinical studies by identifying what product benefits will be of greatest importance to each stakeholder (payer, regulator, patient, provider, and healthcare system) before the start of a trial. This proactive approach to trial design ensures companies capture all of the right long-term health economic and regulatory endpoints the first time rather than running another study to gather the necessary data after FDA approval. Many manufacturers today conduct a second study on the backend of the pivotal study to look at the health economics of the new product. Organizations can eliminate this two-step process through smarter pre-planning.
2. Collaborate with Industry Influencers
Professional societies can serve as powerful advocates on market access for medical device and diagnostics companies trying to introduce a new innovation. Working with a large professional society, manufacturers pool information and leverage the respect and reputation of a society to provide a stronger case to payers. In addition, another strategic way to get coverage for a new procedure or product is for manufacturers to work together—even direct competitors. Rather than work alone, companies that combine forces through a partnership can have a stronger impact when fighting to get coverage, especially in a new product category.
This approach proved successful when a number of stakeholder groups partnered together to secure coverage of cervical artificial disk replacement. “Today, insurance coverage for cervical artificial disc replacement is commonly available to patients that will benefit from the surgery. However, it took many years of medical device manufacturers, surgeons, patient groups, payers, and professional societies like the North American Spine Society (NASS) working together to ensure that patients could gain access to this valuable technology if it is their best treatment path,” Dr. Richard Guyer, co-director of the Center for Disc Replacement at the Texas Back Institute, explained to the authors.
3. Adopt Flexible Technology
In the past, medical device and diagnostics manufacturers could get by using manual tools to manage clinical trials as they only needed to show clinical efficacy to a limited audience. A published paper was often sufficient evidence to prove the viability of a product or procedure. With greater data demands from a wider range of stakeholders and much larger studies across regions, these tools are no longer sufficient.
Medical device and diagnostics companies now also require a more flexible system to handle changing requirements. Compared with the rigidity of FDA requirements, payer requests for data are fuzzier, each often changing cyclically and differing among private insurers. Agile, cloud-based systems that are easily adaptable to changing needs are an important foundation for communicating product value to secure faster market access.
“Advanced technology becomes critical as we are forced to conduct more clinical studies and gather more evidence,” said Andrew Tummon, director of global clinical affairs at Integra LifeSciences Corporation, a world leader in medical technology. “We want to completely eliminate manual processes and automate reporting. We also need a flexible solution that adapts to our changing needs so we can capture the data we need to show value. Just as pharma realized when they updated enterprise technology, the devices industry can benefit from new cloud platforms that allow companies to manage more with less,” Tummon explained to the authors.
A movement to a flexible, cloud-based technology that simplifies and standardizes processes while enabling collaboration with greater data sharing and visibility is the roadmap for the future. The companies that continue with manual methodologies or rigid legacy technology will struggle to collect the regulatory and economic data to address different stakeholder requirements.
Regulators and payers are re-structuring market access for the medical device and diagnostics industry. Healthcare systems and providers also want additional data before making decisions on new devices. The speed and scalability of new product adoption for organizations depend on changing mindsets, processes, and technology to deliver a more complete value proposition without going back in time.
1. “Navigating the Maze of Market Access,” by Durgesh Kahol, MBA, MSc, Laura Haycock, MBioEnt, and Helena Emich, PhD. The Evidence Forum (October 2015), Evidera. See full report here.
2. “Understanding The FDA's Breakthrough Devices Program,” by Mike Wolf, Life Science Leader (2019). See full report here.
3. “3 Hurdles to Bringing Medical Devices to Market,” by Shantanu Gaur, STAT News (September 27, 2018). Retrieved at https://www.statnews.com/2017/09/27/medical-device-approval-fda/.