Manufacturers of medical devices depend not only on the innovative and precise components they have created as the core of the equipment they provide, but also on outside IT hardware and software that must be connected, integrated and managed for the entire medical device lifecycle. That creates a host of challenges in today’s fast-changing IT and compliance/audit environment, from efficiency and productivity to cost and supply cycle times.
The following includes four of the most prevalent pain points we’re seeing in the medical device manufacturing industry today:
1. Manual processes within development & documentation are hindering productivity.
While the use of specialized medical device development tools has slowly increased, many medical device manufacturers are still using manual tools like Microsoft Word and Excel to manage their work in documents and spreadsheets (such as managing test cases in Excel, or Word to manage requirements). That means a lot of time is spent on daily project administrative work and creates a number of difficulties in complex projects.
Too much time is often spent tracking technology component status to support product builds. Manual documentation can not only be erratic and incomplete, but key records can be hard to find in the sea of individual documents. There is often the need to go back and correct poor development documentation, rather than having real-time documentation keep a steady pace with the actual medical device development work.
Further, a manual approach compounds the challenges of documentation among cross-functional teams and remote workers.
Tools that automate this documentation in real-time online environments can free up development teams’ time for innovation and accelerating development compliance. Some medical device manufacturers offload documentation responsibilities of their platforms’ technology components to a capable IT partner.
2. Confidence in compliance and in preparedness for FDA audits is down.
Healthcare and the life sciences in general seem to face a growing tide of regulatory demands every year, and the medical device manufacturing industry is no exception. Combine this with the relentlessly exponential acceleration in the pace of technology, and it’s easy to understand why medical device manufacturers are feeling increasingly anxious about being on top of IT compliance and security.
This applies not only to announced or unannounced MDSAP (Medical Device Single Audit Program) events administered by the FDA, but to company-specific QMS requirements for certifications such as ISO 13485.
In particular, it’s a lack of lifecycle visibility of the digitally connected components, especially during the design and control phase, that can be most challenging – and frustrating – to medical device development teams. Proper device record compliance documentation failings loom large here.
The digitally connected components can reach their end-of-life before the medical device has even gone to market.
In addition to better automation and/or control of the documentation process, proactively managing the entire connected hardware lifecycle across product platforms and configuration transitions can help with compliance and regulatory concerns.
3. Manufacturers are finding key compliance items difficult to prove.
It must be done, but what medical device manufacturers are finding hardest and most time-consuming to prove are documentation, objective evidence, traceability and design history.
This is particularly true for a platform’s connected IT hardware – components that were not even developed by the medical device manufacturer, but acquired from third parties. Compliance documentation such as First Article Records may not even be in the purview of the medical device manufacturer, yet they will be required in an FDA audit.
Finding, gathering and synthesizing this kind of information – in the case of an unexpected FDA audit, for example – can take us back to the blizzard of unconnected Word documents, Excel spreadsheets, printouts and even emails residing in any number of siloed locations, departments or teams.
Again, this is difficult enough on the components that have been developed in-house, but think of the additional challenges in obtaining airtight documentation – (such as the required device history records and Certificates of Conformance [CoCs]) – on the hard drives, servers, laptops, printers and even connector cables that have been acquired from outside vendors.
Look for digital hardware providers that externally connect to medical devices that have processes in place for providing, updating and maintaining the compliance documentation you need for those digital components.
4. Connected devices have created a frontier of new challenges.
IoT (“Internet of Things”) refers to the ever-expanding network of physical devices that features an IP address for internet connectivity, and the communication that occurs between them and other internet-enabled devices and systems. Connectivity and IoT (such as wearables, wireless sensors and much more) are on the drawing board and beyond at a growing number of life sciences companies.
For medical device manufacturers, the first concern that comes to the forefront is not just the technical and R&D requirements, but vastly more complex compliance and security issues.
Medical device manufacturers don’t have to solve all of these complex issues alone; there are vendors who specialize in partnering on IoT projects throughout design, development, validation, production and lifecycle management to help achieve compliant, connected IT devices.
Work With Us
Dynamic Computer Corporation can help ease you past all of these pain points with our proven techniques in deploying and managing the lifecycle of IT hardware connected to medical devices. We ensure compliance and security across all medical device digital components, for the development of error-free business process and product – enhancing platform performance and reducing audit risks. Together, we can streamline your company’s processes to meet the compliance, security, quality and profitability goals your organization demands. Contact us today at 866-399-1084 or email us at email@example.com.
Editor’s Note: This post was originally published in December 2019 and has been updated with new information for comprehensiveness.