Case Study: Human Health & Safety
CHALLENGE.
A global medical device manufacturer focused on improving quality of life for people the world over asked us to:
Build and integrate a 3PL network capable of warehousing and shipping regulated medical products to any hospital, clinic or in-home patient customer within the U.S., Canada or Europe with an OTD rate for expedited / emergency orders >95%.
Design a robust system capable of locating and retrieving any equipment, component or material batch purchased, manufactured or sold in the event of an FDA product recall.
The company was in the process of divesting two large divisions – one, a seemingly clean separation with limited impact, and the other, a much more complex split that represented a major piece of the overall business. (In fact, that division eventually became the company’s top customer, integrated in every aspect of the supply chain.)
A well-designed and stable SAP ERP system had recently been installed but government regulated processes – otherwise known as “GxP” relevant processes – made further system improvements slow, difficult and frustrating to stakeholders.
With highly competent regulatory officers ensuring total GxP compliance spanning all domains and phases of the SDLC, the team’s biggest challenge became how to quickly design, develop and implement solutions with near “100%, first time right” quality.
Although the system was well designed, not all requirements critical to human health and safety were accounted for nor delivered during the implementation. Given the high stakes for a company specializing in life-saving therapies and treatments, there was limited time for error or delay.
SOLUTION.
To close the system’s functional gaps as quickly as possible, we had to immediately begin building the company’s internal IT controls – including developing new procedures and upskilling the team in order to support our new approach.
The first, and perhaps most critical step, was eliciting functional requirements and establishing traceability throughout the SDLC. Because the company didn’t have the in-house capacity needed at that point, we hired best-in-class consultants to teach our business and regulatory analysts a range of best practices for GxP regulated industries.
The second step was to create a comprehensive business process model upon which risk could be assessed and assigned to each functional requirement. This was the primary success factor for improving speed to delivery by being able to right size and scale methods.
Next we created a robust, cross-functional IT change management system to provide the controls needed to not only ensure that the right work was being done but that it was being done according to protocols outlined in the newly established IT quality system.
Lastly, we established a strict document management system ensuring GxP relevant documentation was tightly controlled, accessible and aligned to all requirements needed to maintain traceability throughout all SDLC documentation (e.g., requirements, design, validation, data conversions and cutover.)
Once the IT quality system was implemented and the team was trained, we were able to implement a fully integrated 3PL network. Spanning several U.S. and Canadian distribution centers, the company was now capable of tracing all materials, cradle-to-grave, in the event of an FDA product recall – a must-have function for any medical device manufacturing company.
IMPACT.
By implementing a highly integrated 3PL network capable of executing every aspect of logistics while also adhering to strict regulatory compliance throughout the warehouse, quality and transportation management functions, it became much easier for the company to adequately respond to customer needs and regulatory emergencies.
A new mandatory training program was created and managed by quality control experts to ensure the system was working consistently and correctly. And although the many steps required for implementing an effective GxP solution (particularly compared to non-regulated industries) took time, discipline and a next-level attention to detail, our team became more effective in our efforts to reach company goals. Tools such as SAP Solution Manager allowed us to standardize quality processes and eased access to information resulting in an efficient SDLC delivering solutions that outperformed the company’s competitors.
Over the next few years, the SAP team implemented countless solutions – continuously improving processes, reducing risk and driving profitability by optimizing supply chain networks and technologies. Staff was happy, turnover was low, and culturally we developed an environment where everyone worked together to help improve and save lives.
In turn, the company dominated the market – capturing >80% of market share for its acute lines of business and >60% for chronic.
After exceeding expectations for three years and growing private equity to $4B, the company was sold to a $35B publicly traded competitor aiming to close gaps in its own product offering and business portfolio.