Advances in health care and technology are creating more opportunities for medical device companies to play a larger role as solution providers in the health care value chain. At the same time, the increasing complexity of technology, disruptive companies and a growing trend of medical device and pharmaceutical convergence is making the regulatory environment more challenging and competitive. Given these circumstances, medical device companies are exploring new digital pathways that facilitate faster and more efficient regulatory information management (RIM) and product life cycle development.
Without the benefit of a crystal ball or a definitive fortune cookie, it’s difficult to clearly envision the future of any industry. However, we can conclude with some assurance that things will keep changing. Of course, with how fast technology is moving, new innovations are not so much astonishing as they are expected. This is evident in how consumers are taking a more proactive role in managing their health and interacting with health care providers through digital health technology.
This consumer-driven paradigm is forging new trends in health care, which is changing the way health care providers practice medicine. These new trends will no doubt have an impact on medical device research and development (R&D) and manufacturing.
Despite the fact that device manufacturers are fully engrossed in their current operations, it’s important to look up once in a while to see where the industry is heading. An analysis published by KPMG, a global life sciences audit and advisory organization, reveals a few spoilers on trends that will shape the medical device industry over the next decade:1
In a nutshell, the medical device landscape is poised for growth and the welcome mat is out for companies to pursue new opportunities. However, seizing these opportunities won’t be easy. The aforementioned trends will no doubt raise the bar on regulatory processes. Companies hoping to gain market access and maintain a competitive position will need to chart a course toward modernizing their approach to compliance and expediting regulatory information for new product introductions.
It’s no secret that the world has an abundance of health care issues. This makes the global health care system more fertile for new, innovative products. The new normal for medical device manufacturers is more intelligent, holistic solutions that address a broader scope of the mounting health care challenges. Medical device companies seeking to add offerings to their portfolio should expect to be more agile with R&D, design, manufacturing and product life cycle management methods.
When introducing new health care-related products, there is a sense of urgency to be first to market. However, the pathway to regulatory compliance and market entry is inundated with data, forms and reports that require significant attention to detail, coordination and accuracy. In addition, compliance processes could be hampered by any number of obstacles, including:
The process for getting a new device on the market entails efficiently pursuing regulatory compliance at a fast pace, while avoiding costly delays and setbacks – or worse, a postmarket recall. Achieving market entry begins with removing self-imposed bottlenecks. All departments and processes involving quality, data, documents and regulatory information management need to be joined at the hip. Relying on single point solutions and legacy IT infrastructure components to oversee these critical processes is a sure way to invite obstacles and defeat the purpose of innovation.
The purpose of technology advancements in the health care arena is to streamline operations, cut costs and improve patient outcomes. These objectives motivate product manufacturers to follow suit with their product life cycle development and regulatory information management. This is best achieved by implementing an interoperable digital infrastructure that modernizes compliance and new product introductions.
According to LNS Research, departmental silos and competing priorities are a leading cause of new product introduction failures.2 Add this scenario to the arduous tasks of expediting regulatory information and the path to market entry becomes even more tangled. The challenges in health care call for proactive, yet prudent action from device manufacturers. Having little latitude for errors, companies need to insist on precision and accuracy in collecting, combining and delivering quality data in a timely fashion. Manufacturers gain a distinct competitive advantage by setting up a digital infrastructure that automates these tasks while harmonizing processes across organizational entities.
For details and statistical data on how medical device manufacturers are improving their new product introduction success rates, read the Insight Brief, Regulatory: New Digital Pathways.
“Medical Devices 2030: Making a Power Play to Avoid a Commodity Trap,” KPMG, 2018, https://assets.kpmg.com/content/dam/kpmg/xx/pdf/2017/12/medical-devices-2030.pdf
“Sustainable Growth Via Profitable, High-Quality NPI,” LNS Research, 2018, https://newiso9001.files.wordpress.com/2018/04/ic-qualty-2018-apr-npi-ebook.pdf
David Jensen is a marketing communication specialist at MasterControl. He has been writing technical, marketing and public relations content in technology, professional development, business and regulated environments for more than two decades. He has a bachelor’s degree in communications from Weber State University and a master’s degree in professional communication from Westminster College.