In recent years, the medical device sector has seen a torrent of technological advances, global regulatory disruption and emerging market opportunities. In 2020, the evolutionary pace of the industry is intensifying. Companies that embrace data-driven technologies for production intelligence, seek to innovate their product, and prepare for regulatory change with digital tools to manage data will emerge on top. A new medical device trend brief, “Top 5 Medical Device Industry Trends to Plan for in 2020,” examines specific trends and ideas on how to leverage them to benefit your device company. The following are three of the trends:
In September 2019, the U.S. Food and Drug Administration (FDA) unveiled its Technology Modernization Action Plan (TMAP). In essence, the program seeks to digitally overhaul how the agency conducts its quality and compliance dealings with companies. With vast amounts of product data and new data-driven products flooding the medtech market, the FDA will soon manage product submissions and reviews through the cloud. In order to do so, the agency will modernize its technology infrastructure to ensure highly secure data transfers. TMAP will also promote better and more tech-savvy methods for regulators and companies to interact and partner.
As regulators like the FDA adopt digital transformation, med device companies will need to follow suit. Given the higher regulatory stakes, device makers will want to reevaluate their current quality management systems (QMS) and identify automated solutions that provide proactive, in-line quality assurance. A robust digital QMS affords an organization the ability to track and manage production data at every step of the product life cycle.
Due to rising concerns about infectious diseases, higher life expectancies and expanding markets,
Enjoying this article? You may also enjoy this Trend Brief:
“Top 5 Medical Device Industry Trends to Plan for in 2020"Download Free Trend Brief
The new normal will require closer collaboration with outsource partners and others in the supply chain. A cloud-based tool to share accurate production record data from any location will be essential to reduce errors and review times. A digital production records solution transforms manual, paper-based device history records (DHRs) into trackable electronic versions. This ensures access to accurate and complete data from any location and increases production visibility among partners resulting in operational efficiencies.
The Medical Device Single Audit Program (MDSAP), a harmonized regulatory approval process, achieved full implementation in 2019. In brief, MDSAP allows a device company to undergo a single audit by an accredited third party that satisfies quality regulations in member countries. Currently, that list includes the U.S., Canada, Japan, Australia and Brazil. Though a more stringent pathway as far as evidentiary requirements, the program’s advantage to device makers is fewer audits which translates to less business disruption. Health Canada now requires all devices sold in that country to have MDSAP certification. Add to that the fact that the FDA is planning in 2020 to adopt a form of ISO 13485:2016 (the ISO medical device standard upon which many of the MDSAP requirements are based), and MDSAP starts to make a lot of business sense to a manufacturer.
MDSAP and the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are bringing greater regulatory harmonization to the industry. Their increased requirements necessitate that medtech companies consider digitizing their quality and compliance systems to organize and manage product documentation. Simply put, in a data-centric regulatory ecosystem, a paper-based QMS will no longer cut it. An interconnected, automated QMS can help device makers stay ahead of the regulatory curve while providing the benefits of improved quality insights to lower quality control costs and raise return on investment (ROI).
Medtech occupies a challenging but opportunity-rich space in 2020. Increased demand, new product types like digital health and software as medical device (SaMD), and promising market growth projections bode well for device makers. In order to fully capitalize on market opportunities and prepare to meet the challenges of an evolving industry in 2020, companies will need to be nimble and innovative. To achieve those aims, digitizing quality and production systems offers stakeholders a pathway to reduce the cost of quality, improve regulatory preparedness and increase manufacturing efficiency.
To learn about all five medical device trends, download the new trend brief “Top 5 Medical Device Industry Trends to Plan for in 2020.”