Arena Solutions today announced that its cloud-based medical solution is being rapidly adopted by the medical device industry.
The medical device industry is both highly regulated and highly competitive, forcing companies to constantly innovate to prevent competitors from taking market share with more advanced devices. They must also carefully document all design changes to ensure compliance and avoid having their devices pulled from the market by increasingly complex regulatory bodies.
Arena Solutions provides its medical device customers with the Arena Validation Maintenance Service (VMS). This is critical for medical device manufacturers since they are required to maintain and demonstrate FDA 21 CFR Part 820 Quality System Regulation compliance on a consistent basis. VMS offers ongoing Arena PLM release validation against its predefined intended uses, as well as the complete documentation of validation activities and results for each Arena PLM release.
Because Arena PLM is delivered via the cloud, requiring no on-site equipment beyond a standard Web browser, it can validate every new release of Arena PLM and distribute the results of validation to VMS subscribers. The application of this approach alone can save organizations up to $100,000 in each instance as well as enormous amounts of time and effort. This further enables customers to take immediate advantage of the latest PLM technology advancements without worrying about compliance. In many cases, companies using VMS can validate products on the same day of release.
The market evidence that medical device companies are embracing Arena PLM is clear:
- Well over 100 medical device customers currently use Arena PLM;
- Life Sciences is consistently one of Arena's strongest vertical markets; and
- Arena Life Sciences sales have doubled in each of the last two years.
Here are just a few actual examples of how medical device companies have benefited with Arena PLM:
EMCI: Epic Medical Concepts & Innovations seeks and develops disruptive technologies in a wide array of medical disciplines, including the integration of high-level scientific research and medical innovation, such as Internet of Things (IoT) capabilities, into market-ready devices. Arena PLM makes it simple for EMCI to document change requests and orders. Changes that required five employees to work full time for 60 days can now be accomplished by one or two in less than 30 days.
Swan Valley Medical: Swan Valley Medical is a privately held medical device company focused on the development and commercialization of sophisticated urological surgical instruments. Swan Valley's biggest challenge was not the documentation of regulatory processes but rather the work required to close them. With Arena, Swan Valley no longer worries about engineering change orders (ECOs) being closed improperly — that process is now automatic.
Yukon Medical: Yukon Medical designs innovative products that simplify drug reconstitution and medication delivery, increase caregiver safety, and address complex challenges using novel approaches. Arena PLM was deployed without adding any new IT infrastructure, allowing the company to stop paying contract engineering service providers to manage the product, and making it possible to effectively manage very profitable white labeling partnerships with much larger companies.
"Medical device companies must adhere to complex and heavily regulated design and development processes and maintain regulatory compliance throughout the entire product lifecycle," said Yelena Bolton, senior program manager, life sciences at Arena. "With Arena PLM, customers spend significantly less time and money on ongoing PLM system validation and documentation, and more time developing better products that save lives and generate revenue."
