Article | August 2, 2011

Biomedical Field Service: Clearing The Compliancy Hurdle To Ensure The Service Equals The Technology


By Dave Yarnold, CEO, ServiceMax

There is a revolution underway: from the introduction of tablets and other mobile devices, to SaaS and other cloud-based tools that provide greater flexibility, new technologies are reshaping field service firms — and none more than medical device manufacturers. But for many companies, shedding legacy management systems for a new set of tools means recertifying their processes to demonstrate compliance with industry regulations. For medical device service firms, that means FDA compliance. The good news? The transition may feel hard, but it's worth the effort as new technologies can actually improve compliancy in the end.

Recertifying new technologies, especially in the complex world of medical device manufacturing, can be a hurdle for some firms that aren't satisfied with their current field service management tools but feel overwhelmed by the prospect of a complete overhaul (and the necessary compliance checks). While it may seem like a lot to bite off, biomed firms shouldn't be frightened by change, especially one that may not only reinvigorate and streamline their service operations but also simplify compliancy.

The highly regulated biomedical industry has a slew of compliance issues to address with new technologies. Apart from certifying the manufacturing processes themselves, vendors must find reliable methods to improve record-keeping, manage visibility and tracking information, and generally make sure that the organization is consistently reporting on the correct information and is adhering to regulations. In the past, they may have accomplished this with a patchwork of custom software, but many are considering the leap to the cloud and other tools to better manage this process. And for good reason. These firms manufacture some of the most high-tech equipment in the world, and yet many rely on pens, paper and legacy software from the Internet Dark Ages to manage their service teams.

Service compliance is process-driven, and by moving away from paper and into electronic formats that allow the FDA to easily review the manufacturing process, biomed service firms can increase compliancy and customer satisfaction. Dashboards allow for easy visibility into service operations, and tech solutions allow firms to easily track data, maintain customer and product histories and report on appropriate information to the FDA — all from a central location, accessible to all employees.

The ability to maintain clear and consistent records, grant instant access to information and equip service firms with better visibility ultimately ensures quality and compliance. And while the biomed industry has its own dizzying set of regulations, the benefits of making the change are real and immediate. There is a learning curve for organizations to re-up on all certification after making the switch to new technologies, but the payoff greatly exceeds the growing pains, helping them stay competitive and compliant and keeping customers happy with great service and products that work - and receive the FDA's stamp of approval!

SOURCE: ServiceMax