Mastering complexity and global compliance in B. Braun’s field service organization
- In an ever-changing and increasingly complex regulatory environment, it can be difficult to ensure compliance with medical device regulations in multiple countries. Deirdre Yee of ServiceMax delves into B. Braun's experience of transforming field service operations.
In healthcare and medical device manufacturing, patient safety is priority number one. Staying on top of compliance throughout the lifecycle of a device is essential. As one of the world’s leading medical technology companies, B. Braun’s objective is to protect and improve the health of people around the world. For more than 180 years, the company has played a critical role in shaping and enriching healthcare globally by combining its pioneering spirit with product innovation. The company’s products, solutions and substantial Research and Development initiative are setting new standards in both hospital and outpatient care.
That innovation has been as equally applied to its ground-breaking healthcare products, as it has to its internal global operations, particularly in service maintenance. Back in 2019, B. Braun’s service organization deployed the global ServiceMax field service management platform to further improve the uptime and lifespan of its products and transform its service operations and compliance management. Today, the company is reaping the rewards of that investment.
From lifecycle and traceability to complex compliance
The main trigger in moving to a new field service management system was traceability, as Philip Haller, Director IT – Product and Service Idea to End of Life, at B. Braun Group, explains:
In the medical device industry, lifecycle and traceability are critically important. Some of our products are installed in hospitals and clinics, while others are literally implanted into the human body.
In a fast-changing and increasingly complex regulatory environment, it can be difficult to ensure compliance with an ever-changing array of medical device regulations in multiple countries.
Staying on top of compliance throughout the entire lifecycle of every product is crucially important. This has particular challenges when it comes to field service maintenance. B. Braun must be able to illustrate servicing activities and procedures to ensure any maintenance work or replacement parts are compliant with local regulations. All of this requires detailed documentation for auditing purposes, especially as an auditor will ask for examples. Haller elaborates:
ServiceMax enables us to have device service data at our fingertips. By capturing and analyzing devices within one software platform - rather than multiple tools with conflicting data formats and manual processes - we can cross-reference and mix and match data requirements depending on the specific needs of local regulators. This ultimately saves us time and money and enables us to focus on the most important task - protecting and improving the health of people worldwide.
Asset-centric view of service data
With more than 1.5 million different types of products installed globally, and 50,000 work orders for service maintenance per month, the process was previously a paper-based manual system, which was both time consuming and open to human error. Today, thanks to the data capture, visibility and traceability ServiceMax delivers, the company can digitally and easily fulfil its disparate compliance and reporting requirements from different regulatory authorities globally – each with their own regulatory standards and reporting obligations. Haller says:
We have an asset-centric view with regards to service data. We can now bring data together to ensure the right technician with the right skills is deployed to the right location at the right time. Aside from our compliance and regulatory obligations, our products need to be working optimally to ensure the best outcomes for patients, which is why service maintenance is so important to us.
Service data, strategy and architecture
B. Braun has already widely deployed ServiceMax globally and will continue to roll it out across additional regions over the coming year. Haller comments:
The traceability into our installed base that ServiceMax delivered was a game changer for us back in 2019...Over the next decade, our strategy is to achieve digital excellence across all our harmonized processes, from regulation and compliance to sales, service maintenance records and our ERP system. We’re now looking at how to connect ServiceMax to our overall architecture to establish a single source of truth for all product data in the organization by connecting everything.
We’re striving to be data driven not document driven. Moving forward, we’re looking at how best to connect different platforms in the business, including ServiceMax, with our overall architecture, rather than just at the feature level.”
This will include connecting the ServiceMax Go mobile app to the overall architecture in the coming months.
The shift to digital
The size and complexity of B. Braun’s digital challenge is substantial when you consider the breadth of its products – which are becoming more complex with the addition of robotics and artificial intelligence – the constantly changing compliance obligations of 140 regulatory authorities, and its 66,000 employees spread all over the world. Haller concludes:
Our CEO has stated that one of her strategic objectives is for B. Braun to become a technology company, and to achieve that, we need to manage our product data in an efficient manner. That means full digitization, not wasting time on non-productive tasks, and ensuring we have accuracy, efficiency and visibility. As a 180-year-old company, that’s a huge cultural shift in every department.
We see ServiceMax as more than a software vendor. We have a strategic partnership between our two organizations, which means we work together very closely around long-term collaboration.”