A Data-Centric Approach to Propel the Future of Device Innovation

Some pretty amazing medical technologies emerged in the past year that are shaping and transforming the industry. From a mind-reading wristband that may have rehabilitation applications for patients recovering from a stroke or amputation to a handheld ultrasound device that may soon serve some of the 4 billion people that don’t have access to medical imaging, the medical device industry is all about imaginative methods to innovate.(1) The next thing you know, Star Trek’s handy medical tricorder that instantaneously diagnoses injuries and illnesses may be a reality.

Though we don’t want to get too far ahead of ourselves, projecting out where medtech will be in 2030 can help us create a conceptual roadmap on how to get there. Science and technology are evolving at an exponential rate, but we can still identify leading trends and factors impacting the market over the next decade. A new e-book “Mastering Data to Drive Medical Device Innovation to 2030” looks at some of these forward-thinking issues to help device makers plot a successful course forward.

A pivotal point in the e-book is the relationship between product life cycle data and device development and innovation. Another theme is how manufacturers can harness that data for real-time quality and compliance and to leverage these new technologies to gain valuable insights and intelligence.

Demographics and Devices

Between 2015-2030, the number of people in the world aged 60 years and over is expected to grow from 900 million to 1.5 billion.(2) The medtech sector has responded by developing new product types to aid older adults, a market which in the U.S. is anticipated to be worth $30 billion in the next three years.(3)  These include devices for safety, smart living, health, remote care and fitness.

At the same time, the preferences of younger tech-savvy generations have led manufacturers to produce digital health concepts that result in:

• New product expectations.
• Creative applications of connected and proven technologies.
• On-demand preventative and personalized care, such as software as a medical device (SaMD) and similar devices.

The common denominator between the two influences is that both are turning to the digital transformation to synthesize new ways of employing data and devices for quality management and innovation. Coming together at the crossroads, technology, data and new product types are fueling innovation and demand in medtech.

Digitization and Data

Newer technologies such as artificial intelligence (AI), machine learning (ML), the internet of things (IoT) have made many of these new connected, data-centric devices possible. But they’re also transforming the shop floor. Concepts such as Industry 4.0 posit that factories of the near future will have interconnected, digitized production systems that allow real-time quality management. They can also monitor and make in-line production adjustments at any point within the product life cycle. When a quality event does occur, automated systems that communicate with each another allow more effective and faster corrective and preventive action (CAPA) and activate training tasks. Instead of trying to make heads or tails of fallible paper records from disparate systems, managers can use an integrated digitized production records solution that provides a single source of truth to ensure that production data from a variety of systems is accurate and complete. This allows manufacturers to shave time off lot review cycles, from weeks and days to hours and minutes.

Through big data analytics, raw data can be extrapolated into valuable intelligence and insights for manufacturers to:

• Optimize manufacturing processes.
• Improve clinical trials with real-world data (RWD).
• Predict product quality issues.
• Create intelligent products.

Thus, a data-centric approach to quality processes and systems will be critical for device makers to more effectively manage the entire product life cycle. In fact, data itself will play a more prominent role from design and development to postmarket surveillance collection. According to an Ernst and Young study, data itself may soon become the most valuable commodity to manufacturers.(4) To the extent that medtech companies can leverage that data to make informed decisions and predict outcomes will determine their market success in factories of the future.

Data and Regulatory

Manufacturers aren’t the only ones beginning to see the value of  the transformational forces that are bringing data and digitization to the forefront. Regulatory agencies, including the U.S. Food and Drug Administration (FDA), are modernizing and harmonizing infrastructure and regulations to adapt to this new reality. Vast amounts of data produced by new product types and more automated manufacturing can quickly overwhelm regulators handling reviews and submissions. Processes that were once document-centric are now evolving to become data-centric. In part, this means more stringent regulations to ensure compliance. But it’s also resulting in increased regulatory modernization to better accommodate and expedite reviews and approvals.

For example, under the the FDA’s Technology Modernization Plan (TMAP) regulatory reviews and submissions will soon be transmitted through the cloud. Advanced technologies will provide the level of security needed to expedite and streamline current regulatory processes. Similarly, the Medical Device Single Audit Program (MDSAP) and the European Union’s Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR) will allow manufacturers and regulators to connect and transfer product data at the speed of digital. A more transparent, data-centric model based on evidence and reporting of increasingly more complex devices will help ensure patient safety and efficacy while accelerating the regulatory process.

“I strongly believe that we need to do everything we can to attain more and better data for the work we’re doing, to be more proactive in gathering data, and to be more creative and thorough in our analysis of it,” FDA Commissioner Stephen Hahn said in January 2020.(5) “By harnessing this power, we can improve our regulatory decision-making and more effectively connect today’s groundbreaking scientific discoveries with the rapid development and approval of new products.”

The Platform and Productivity

A medical device company won’t survive until 2030 (or even 2025 for that matter) if it’s still reliant on slow, error-prone paper-based or hybrid quality management and production record systems. Device makers won’t be able to retain a competitive advantage in the face of increasing price pressures, more stringent regulations, M&A disruption, and shortened deadlines even as competitors and regulators move toward digital transformation. Companies are already engaged automated solutions and technologies, including the cloud, in an effort to differentiate themselves and gain greater return on investment (ROI) from their data. Through this interconnectivity, manufacturers can link departments, systems, processes and people throughout the product life cycle from concept to commercialization.

With a robust automated quality management system (QMS) at its core, an integrated digital platform gives a company the ability to track and manage production, supplier, clinical, regulatory and postmarket data that generates quality intelligence and actionable insights. A Deloitte report of industry projections for 2022 indicates that companies’ digitized supply networks are expected to deliver “significantly improved outcomes” using ML and 3D printing that produce data flow for enhanced tracking.(6)

As an integral part of platform solution, a closed-loop digital QMS integrates with other manufacturing data systems as it performs proactive, in-line quality assurance. With the help of new technologies, the capabilities of these automated systems will soon enable device makers to convert product quality data into real-time predictive insights that:

• Help increase speed to market.
• Foster greater innovation and new product types.
• Offer improved customer alignment.

And as effective collaboration with outsourcing partners and others in the supply chain become even more critical to companies’ bottom lines, the value of a platform approach’s connectivity and communication increases.

Conclusion

Though we don’t have a crystal ball to tell us what exactly to expect over the next 10 years, current device market and manufacturing indicators give us a fairly good idea. The unstoppable march of technology and digital transformation will shift device manufacturing toward Industry 4.0 where a data-centric approach to product innovation and production will become the new standard. Companies that are more agile and that have formulated a strategic plan for incremental digitization will be best equipped to succeed in the future.

References

1. “12 Innovations That Will Change Health Care and Medicine in the 2020s” Time magazine. Oct. 25, 2019. https://time.com/5710295/top-health-innovations/
2. “Aging Populations Will Challenge Healthcare Systems All Over The World” by William A. Haseltine. Forbes magazine. April 2, 2018. https://www.forbes.com/sites/williamhaseltine/2018/04/02/aging-populations-will-challenge-healthcare-systems-all-over-the-world/#62c8f3282cc3
3. “7 new tech devices for elderly care that help seniors live happier, healthier lives” by Julie Halpert. CNBC. Sept. 12, 2019. https://www.cnbc.com/2019/09/12/7-new-tech-devices-for-that-help-seniors-live-happier-healthier-lives.html
4. “As data personalizes medtech, how will you serve tomorrow’s consumer? Pulse of the industry 2019” Ernst & Young. 2019. https://assets.ey.com/content/dam/ey-sites/ey-com/en_gl/topics/life-sciences/life-sciences-pdfs/ey-pulse-of-the-industry-2019.pdf
5. “FDA’s new chief stresses data, consumer empowerment and innovation” by Nancy Crotti. Medical Design & Outsourcing. Jan. 31, 2020. https://www.medicaldesignandoutsourcing.com/hahn-outlines-goals-for-fda/
6. “The future awakens: Life Sciences and Health Care Predictions 2022” Deloitte. November 2017. https://www2.deloitte.com/global/en/pages/life-sciences-and-healthcare/articles/healthcare-and-life-sciences-predictions.html