The medical technology industry is continuously striving to provide innovations that can improve patient outcomes and improve their quality of life. But what if someone can’t access a medical device or diagnostic that can help them? Nearly 80% of US counties are classified as medical deserts, where getting adequate care is a challenge.¹ To address this, the FDA, the Center for Devices and Radiological Health (CDRH), and medical technology companies are prioritizing health equity to give all patients a fair chance to get the best possible care.

Without access to essential medical devices, patients may experience reduced quality of life, prolonged illness, or even preventable death. Lack of access can also exacerbate health disparities, particularly in underserved or remote communities labeled medical deserts. As an industry, medtech seeks ways to ensure health equity for everyone, so that every patient can achieve their highest level of health, regardless of where they live, race or ethnicity, gender, disability or status socioeconomic.

The path to get there is not linear and may differ for each organization. However, one thing is clear: promoting health equity and improving patients’ lives is a priority. Advanced companies are moving beyond traditional ways of working, enabling more connectivity and speed across the entire product value chain to better serve all patients.

Navigating changing healthcare delivery approaches and patient expectations

The way patients receive care has changed dramatically over the past 20 years, moving from an on-site model to a hybrid model that includes virtual visits and remote data capture. Healthcare providers now have vast amounts of data to analyze before deciding on the best approach to care, and patients are better informed with expectations for their treatment options.

With technology at their fingertips, patients are empowered, engaged, and better understand ways to approach disease. A recent survey found that 85% of engaged patients report a moderate or significant improvement in their health experience, and 76% feel more informed about their health.² Engaged patients are good for the industry, but are medical doctors and companies keeping up?

Doctors are making strides to ensure a more modern and hands-on medical experience as the adoption of digital tools, such as devices that enable virtual visits and remote monitoring, among doctors has grown significantly. A study by the AMA found that physicians use an average of 3.8 tools, an increase from the 2.2 tools reported in 2016.³ The same research shows that nearly 9 out of 10 doctors believe that digital tools are an advantage to patient care, potentially simplifying some of the administrative burden required in the past.

“Patient expectations are changing—they’re looking for more affordable care and are increasingly empowered to take an active role in their health,” said Dr. Joanna Mitri, MD, MS, chief medical officer at Sequel Med Tech. “As an industry, we need to provide tools to support delivering a positive patient experience.”

The medical technology industry is evolving to meet the needs of its stakeholders by advancing its processes and embracing connected technologies that provide transparency. This allows organizations to share information and data with doctors and patients that can provide insights and drive health equity.

“Patients are now more vocal and know more about what their outcome should be,” says Paul Swift, head of regulatory and clinical affairs, Americas, at ZEISS Medical Technology. “We have apps that help doctors see insights to better understand the impact on the patient and what they’re experiencing.”

Prioritizing data transparency between teams and stakeholders

Having accurate and reliable data to make product decisions is critical to driving speed and compliance when developing a new product or device. Obtaining regulatory approval or clearance for medical devices requires complete and accurate data demonstrating the device’s safety, efficacy, and compliance with regulatory standards.

“If we don’t have the clinical data and we don’t meet the compliance needs, the product doesn’t come to market. Period,” adds Swift. “Our ecosystem is designed so that we can provide devices and solutions that help capture the data that doctors and patients need to make the best care decisions possible. We can help doctors seamlessly share information with patients through digital applications so they can receive optimal care and personalized education for disease management.”

Data plays a bigger role in health equity. However, suppose companies can better manage data, collaborate more effectively with sites, provide better and easier access to information, and view data about patients using their products in real time. This would allow for faster strategy adjustment, avoiding delays or withdrawals, and may help capture or prevent serious adverse events (SAEs) earlier.

“We need all the data to help our teams take preventative action,” said Shrikant Ramachandran, vice president and CIO at Boston Scientific. “It’s important to know everything from the number of doctors a patient has seen to what procedures have been performed. Data sharing should be continuous throughout the patient care value chain.”

Ramachandran is committed to making data as accessible as possible. However, companies must consider regulatory requirements. Establishing clear governance ensures that data meets standards and compliance requirements. A proper governance strategy can help obtain reliable data from a clinical device or system.

“With the data explosion we’re experiencing as an industry, the data captured through our products is cleaned and synthesized before it’s usable,” says Ramachandran. “Standardized data can provide valuable information to the patient and physician.”

Having core systems such as enterprise resource planning (ERP) integrated with clinical, regulatory and quality systems can enable the continuous flow of data throughout the product lifecycle.

Dr. Mitri says it’s critical to get teams across functions on the same page at the very beginning of implementing change. “Aligning all stakeholders early in the process – whether from quality or regulatory, patients or healthcare providers – is essential. Payer involvement can help address market access challenges. Early involvement of these groups can save time and prevent unresolved questions from arising later in the process.”

Collaborating to deliver more innovation and value to patients

Innovation cannot happen in a vacuum. It requires a forward-looking vision that transcends a specific function and enables cross-team collaboration. To lay a foundation that drives innovation, medtech organizations should align people and processes and enable them with connected technology, facilitating cross-functional work and information sharing. This approach can help bring product development, IT, and sales together so they all work toward one goal: serving patients faster and more efficiently.

The traditional medtech model was that each team remained primarily in their own functions. Now companies are working harder to break down silos. “To achieve more efficiency throughout the process, try to drive higher levels of collaboration across all areas to deliver more value to the patient and the organization. We can no longer do things in silos,” says Ramachandran.

It can be challenging to switch to this approach. However, medtech teams should start with an agile methodology that allows them to build on successes. Mitri says setting standards can make it easier to drive a transformation because data is formatted in the most useful way.

In the industry, everyone collects data. The data itself is vast and complicated and can range from preclinical to clinical, biocompatibility, performance, software, post-market, competitive, and more. Finding ways to work with regulatory agencies to bring all this data together can help the industry stay in sync, Swift adds.

“We are close to seeing the true definition of patient centricity,” adds Ramachandran. “A value chain that connects all the systems needed to provide a perfect patient experience. It’s not far, and we already have a lot of technology working together to make this a reality.”

With connected systems, data can flow seamlessly from the device to a system and then to an app for doctors and patients. This can make the difference in empowering stakeholders and achieving the best possible outcomes for people in need, everywhere, exactly when they need it.

As regulatory bodies begin to add diversity reports to the list of approval requirements, physicians are encouraged to submit reports on how they support underserved populations in trials. If a company designs a product specifically for underserved patients, it could qualify for breakthrough designation, which would mean faster approvals and better reimbursement. A focus on improving health equity can provide significant value to patients and industry. There is no time like now to start driving change to address health equity challenges.

References:

1. GoodRx Health, Mapping medical deserts: 80% of the country lacks adequate care2021
2. pocket health, 4 good indicators that informed patients have better outcomes2022
3. AMA, 5 insights into how doctors see and use digital health tools202