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How to Navigate the Regulatory Landscape for Medical Devices

Victoria Ebel, Appian
August 16, 2018

A sharp rise in adverse events in the medical device industry over the last five years has prompted the creation of new and heightened regulations. The FDA established more than a dozen new documents in 2016 and 2017 that set new medical device regulations outlining expectations for risk assessment. The European Commission has also developed new regulations for medical device organizations throughout Europe.

And now, the 2016 revision to the medical device regulation ISO 13485 will require the incorporation of risk management into every aspect of the quality management system by every medical device company by March 2019.

These increasingly complex regulations are creating new challenges for medical device companies. Navigating the regulatory landscape with outdated process models is impeding organizations from bringing innovative devices to customers, and putting them at risk for potential fines. The processes and systems currently utilized by many medical device companies do not offer the amount of transparency and control needed to comply with regulations, or enable easy and open collaboration with external partners.

The Introduction of New Technology

Many medical device companies are managing imposing regulations by adopting new systems. A modern application platform can provide the streamlined processes, control, automation, and visibility needed to maintain compliance across the supply chain.

Moving forward, organizations are gravitating toward platforms with cloud enablement and blockchain to meet their regulatory needs:

    • Many medical device companies are implementing cloud enabled systems. Cloud simplifies process management and reduces cost by allowing storage and activities to move away from infrastructure and into the cloud. Cloud platforms facilitate automatic system updates that ensure compliance for evolving regulatory needs.

"Just as the pharmaceutical industry realized, the devices industry can benefit from cloud platforms that allow companies to manage more with applications allow us to work smarter and from convenient locations. Remote workers and frequent travelers can upload reports in real time from investigative sites, hotels, anywhere . . . saving time and improving accuracy." Andrew Tummon, director of global clinical affairs at Integra LifeSciences Corporation

    • Organizations are turning to blockchain-enabled business process management.

    Blockchain creates a secure, reliable, and auditable way for regulators and developers to continuously share and update secured data. Paired with a business process management system, developers can follow the lifecycle of a medical device, from ideation to commercialization, ensuring that regulations are met and that the product is safe and effective.

"The disparate systems used by pharmacies, healthcare providers and insurers to manage medical information are extremely complex. They are not designed for the smooth exchange of data...The Appian blockchain adapter will be a step towards seamless integration across the healthcare ecosystem enabling payers, providers and patients to exchange and verify data in a safe and compliant way." Sam Mantle, Managing Director of Digital Enterprise at Luxoft

Using A Platform Approach to Manage Regulations

To maintain compliance among increasing and evolving medical device regulations, companies must change their processes and implement new systems. The companies who will become the most successful are those who will embrace new, holistic technology sooner, not letting regulations impede their innovative work.

A platform approach to regulatory operations allows organizations to gain more control over their processes and better manage regulations. Appian's platform offers both cloud enablement and blockchain capabilities to help medical device companies meet their compliance needs.

To learn more about how Appian's Digital Transformation platform is helping with regulatory operations for medical devices and the life sciences industry, visit our resource center.