Streamlined Innovation is Streamlined Compliance for Medical Device Manufacturers

According to figures from and Fierce Medical Devices, the US medical device industry is now valued at over $127.1 billion, a 54 percent increase compared to a decade ago, and the global medical device industry is expected to jump by 4.4 percent per year in 2018. This is thanks to the spur of competition for newer, more innovative medical devices that can deliver quality care to patients, while also including the economic effects of lower prices for the technology — and greater attention to costs by manufacturers.

In an effort to keep administrative costs down so that more resources can be applied to R&D, companies run the risk of overlooking or skimping on necessary regulatory information and compliance activities, which can lead to severe fines, lost revenues, and a stinging blow to a company’s reputation in the eyes of its customers. This is a risk that can be exacerbated by inadequate or complex systems, as well as management stuck in its silos. Improving regulatory compliance will require companies to both improve their document and data management systems as well as encourage cross-functional collaboration.  The need for holistic collaboration extends beyond just internal departments, and includes suppliers and partners outside the company, which will ultimately also have the benefit of increasing innovation in order to stay competitive in this growing industry.

Be holistic

As has been said many times in our research and our white papers, an innovation platform provides the kinds of advantages in single source of truth and quick response that other types of management structures can’t match. In industries that tend to gravitate towards silo management, managers and engineers rarely see anything outside of their immediate purview, which can create the illusion of a well-run ship while ignoring holes in the hull at the other end.

Having a single collaborative system allows a company to store quality and compliance data in a central location so that the company can be fully abreast of the regulatory statutes and limitations it has to follow. In this more simple, holistic format, product and process information is easily accessible, monitored, and tracked for all relevant stakeholders, leading to quality improvements on the fly using real-time information and early visibility into business processes.

Yet this isn’t just about regulatory compliance, as a single system can also make it easier to accelerate innovation through greater communication with customers and throughout the supply chain. This end-to-end collaborative framework helps companies get “the voice of the customer” into their design requirements, which enables them to create more personalized healthcare experiences. With streamlined document change and approval process, engineers and designers can also spend less time looking for data and new information, allowing for innovation to flourish in a more cost effective, less time consuming manner, especially when regulatory compliance is integrated with project management capabilities.

Going Beyond Compliance

An efficient innovation platform isn’t just about complying with the law, it’s also vital for allowing the free flow of information within a company as well as with the relevant stakeholders that have an interest in innovation, albeit the shareholders looking for increased profits or the surgeon looking to improve the outcome of his patients.

Learn More
 For more on how simple, holistic solutions can improve medical device innovation and compliance, read our newest white paper “Beyond Compliance


Jennifer Petrosky

Director of Marketing for the Life Sciences Industry at Dassault Systèmes
Jennifer Petrosky is the Director of Marketing for the Life Sciences Industry at Dassault Systèmes (3DS) and enjoys working with medical device, pharmaceutical & biotech companies to help deliver advanced therapeutics to patients around the world.