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. It’s a difficult balance. To achieve it, medical device companies have increasingly turned to Arena PLM.
Arena Solutions also 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 predefined intended uses, as well as the complete documentation of validation activities and results for each Arena PLM release. The process can be so burdensome for customers to complete on their own that many medical device companies delay or forgo upgrades of traditional PLM products simply to avoid expensive validation testing of updated systems. Arena VMS removes the headache of PLM product validation so that Arena customers can always enjoy the latest updates without regulation concerns.
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.
“Medical device companies must adhere to very 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. “Our cloud-based PLM validated solution enables compliance and integrates product records (DMRs/BOMs), quality records and documents (DHFs), quality processes (CAPAs, CARs, NCMRs, etc.), and changes into one centralized system of electronic records, easily accessible by all cross-functional teams including suppliers. 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.”
Here are just a few actual examples of how medical device companies have benefited with Arena PLM:
Epic Medical Concepts & Innovations (EMCI) seeks and develops disruptive technologies in a wide array of medical disciplines, and is currently focused on integrating high-level scientific research and medical innovation, including Internet of Things (IoT) capabilities, into market-ready devices. IoT, in particular, is an emerging field, and standards for what types of data can/will be shared and how security will be handled have yet to emerge. EMCI must be highly sensitive to any changes in technology standards and avoid areas in which there is no clear route. With Arena PLM, manufacturers and industry leaders alike can view each other’s information in real time, enabling an open, transparent discussion about these issues to identify potential roadblocks early.
EMCI also sees great value in the tight integration between Arena PLM’s BOMControl and Quality modules. When engineers change a specification on one part of a device, they immediately know what other parts, products, procedures, and manufacturing processes are affected. This makes it simple to document change requests and orders, because they can interconnect with EMCI’s CAPA process within Arena Quality.
“We have found that a change requiring a staff of five or six to work full time for 60 days can be accomplished by a staff of one or two people in less than 30 days,” said EMCI’s Vice President & COO Peter B. Lucas. “This is a tremendous benefit for us, because we have a lot of projects going at any given time. Those people who would have been tied-up on a change can now work on advancing other product development projects.”
Swan Valley Medical
Swan Valley Medical is a privately held medical device company focused on the development and commercialization of sophisticated urological surgical instruments that enhance and improve upon existing surgical devices and procedures.
One of Swan Valley’s biggest challenges was managing information to organize evidence of compliance.
With Arena PLM engineering change orders (ECOs) are reviewed, approved, or rejected without interruptions, enabling release management/revision control with minimal administrative work and distractions.
“When we’re going into these quality systems with Arena, we’re using an unbreakable repository system for cross-linking all the evidence,” said Swan Valley Medical’s Chief Operating Officer, Laurence Sampson. “It’s tremendously useful that quality processes can be tied-in directly with the tasks associated with getting the process completed.”
Yukon Medical designs innovative products that simplify drug reconstitution and medication delivery, increase caregiver safety, and address complex challenges using novel approaches. Yukon needed a PLM solution to ensure that its suppliers and manufacturers had accurate, up-to-date product information. Also, employees needed access to the data from anywhere on any device, and the company did not want to hire additional internal IT infrastructure that Yukon would need to support.
Arena PLM was simple to deploy, requiring no on-site equipment. Up and running in just a few weeks, it provided suppliers and manufacturers access to a single version of the truth for products, allowing them to easily communicate to resolve issues quickly. Equally as important, Arena was critical to commercializing the most profitable products by allowing suppliers and manufacturers to private label them to large medical device companies. All of Yukon’s records supported in their larger partners’ change management systems are direct exports from Arena PLM.
No IT infrastructure was added, and Yukon was able to stop spending so much money on contracting engineering service providers to manage the product — both from a compliance and a development standpoint – and they brought it in house.
“Our success depends on efficient collaboration with our manufacturing partners around the world. When challenged with management of manufacturing documentation and records for a near endless possibility of custom products, we knew that we needed a PLM solution. We realized that Arena was offering a PLM solution as a cloud-based service, and we were sold,” said Derek Warmack, project engineer at Yukon Medical.
About Arena Solutions
Pioneer of cloud-based PLM, Arena’s suite of PLM and supply chain solutions enable engineering, manufacturing and their extended supply chains to speed prototyping, reduce scrap, streamline their supply chain, improve margins, and collapse time to market. Based in Foster City, Calif., Arena’s PLM applications simplify bill of materials (BOM) and change management for organizations of all sizes, and the company has been ranked as a Top 10 PLM provider and Top 5 Supplier Collaboration solution. Arena also holds a spot on National Association for Business Resources’ “San Francisco’s Best & Brightest Companies to Work For” List for 2014. For more information, please visit: https://www.arenasolutions.com/