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Digital Transformation in Med Device – How cloud-based field service can help your business go 10X!

Notes from a Lonely Life Sciences Digital Transformation Junkie (A.K.A Bryan Coddington)

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Digital Transformation isn’t about meeting your goals; it’s about blasting through them and reinventing your business. To do that, you often need to throw out the book and find solutions that are new, bold, and even disruptive to your team. As a medical device company, those solutions aren’t just about the latest and greatest technology but ones that also meet the rigor and requirements of the quality organization.

We all know moving to the cloud is a big part of going digital but in Regulated/GxP business areas, such as field service, the qualification of a platform can be a daunting challenge to even the most experienced quality team. But don’t fear the cloud, for it can be as easy as identifying three things - What, Who, and How.

“What” means what are you qualifying? What does the cloud system consist of? Things like configuration, integration, traceability, change control, release management, disaster recovery, user requirements, and IQ/OQ/PQ must all be documented, risk assessed, and tested if needed.

“Who” means who is responsible for the items listed above? A cloud vendor is responsible for their infrastructure, release management, and disaster recovery. As a customer of a cloud platform, you are responsible for documenting and testing your configuration, integrations, user requirements, risk assessment, traceability, IQ/OQ/PQ, and change management.

“How” is about how to accomplish the items you are responsible for. It starts with performing a risk-based qualification effort and then continuing to leverage the supplier’s activity to eliminate the need to re-qualify low risk items. From there, analyze any custom elements and specific configurations against the latest system requirement spec (SRS) and OQ. You then determine gaps and create new scripts (PQ) if needed on top of current SRS and OQ. Finally, you must establish a release upgrade strategy by performing an analysis and testing any issues with step by step guidance.

Now that you know the basics for qualifying a cloud-based field service application, how can it really transform your business? Imagine an application that was built from the ground up to be mobile and collaborative with enterprise analytics and customer/partner communities. But because it’s cloud, you might be thinking that not all areas have Wifi connectivity - and that’s ok. Today’s cloud-based field service applications, like ServiceMax, have offline capabilities so your team can access their data anytime from anywhere. We can go even further with predictive maintenance and IoT, connecting devices out in the field to your application to automatically create alerts and assign technicians.

So how do you be bold and disruptive within your organization to implement a cloud-based field service application? The numbers tell the story. 18% increase in productivity, 13% increase in service revenue, 11% reduction in costs, and 11% increase in customer satisfaction. Management will want this type of change and as you read above, your quality team can sleep at night knowing that cloud platforms like ServiceMax can be qualified.

 

 

About the Author

Bryan Coddington 85x105 rightBryan Coddington is the Vice President of Cloud Technology at USDM Life Sciences. For almost a decade, Bryan has been a senior executive in the Cloud space with in-depth knowledge of sales, marketing, and service and support processes and best practices, helping companies maximize their investment in cloud-based CRM applications.

 

About USDM Life Sciences

USDM Life Sciences is a global life science and healthcare services company, providing strategy and compliant technology solutions to regulated industries. If you work in Life Sciences or Healthcare, partnering with USDM Life Sciences makes it easy to accelerate innovation and maximize productivity. USDM Life Sciences only focuses on regulated industries and has built trusted partnerships with the most innovative technology companies in the world, and boast a staff of industry leading experts in the areas of technology and compliance.

 

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    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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