Over the last 4 years a large multinational medical instruments business had grown significantly through a highly successful acquisition strategy. Each acquisition brought new products, new markets and new customers, and business was booming. However the board had concerns.
The medical instrument industry is a highly regulated environment. Not only did the regulations change between countries and regions, verification of compliance to those regulations had to be independently tested and documented to maintain a licence to manufacture. The board also knew that there were significant benefits to be gained in establishing a common, holistic Quality Management System (QMS).
If such a system was in place it would save time, money and more importantly allow scarce and valuable skilled resources to dedicate their efforts toward research and development for new products.
The tcompany knew from experience it did not have the “in-house” program management skill or experience to manage a multi-division, multi-country, multi-standard initiative. They had tried to do this in house before and had failed; the board needed this to be successful. After a review of the market the board requested program design, enablement and monitoring assistance from Mindavation.
The independence provided to engineering areas also presented other challenges for the program. Terminology differences, perceived outcomes of product testing and an assumption that medical instrument regulations were “all the same” across geographies caused efforts to stall with the potentially expensive re-work and testing. These “differences” gave the impression that a single holistic approach to quality management might be just too hard and simply not be feasible.The boards direction was very clear. Supportour people, realise the benefit from a common quality system, and make it sustainable! For the employees who had come into the business through acquisition this change had the potential to be very uncomfortable. Even though the Financial and HR processes had been integrated across the acquired business units, system and process integration had gone no further.
Initially this was a very sound business decision, the board did not want to stop the creativity and technical innovation in the instrument production and engineering business. As such, each geography was left to operate as independent entities. This had worked well for development, but created significant inefficiencies with product and regulatory support. The development teams also struggled with a lack of recognised sponsorship, as no single engineering and development leader was recognised overall across geographies.
Finally, the project team was presented with a “shifting playing field”. As the Quality and Integration program progressed, new products were being released which might require retrospective changes and updates to comply with any new centralised testing and existing quality measurement process and testing rework was not an option.
To consolidate a consistent medical quality assessment process and embed testing skills within the company, Mindavation provided program design services, fortnightly program assessment and coaching sessions for the company’s program management staff.
After reviewing prior integration experience, Mindavation proposed 4 key tasks. In sequence these were:
- Create an “as-is” quality process collection project to better understand existing quality approaches across the engineering organisations
- Compile an inventory of regulatory testing outcomes required across all geographies, and assess commonalities
- Assess potential “centres of excellence” for various testing regimes that could be leveraged across all geographies, and
- Design an organisational change management support initiative to ensure successful business integration, while supporting the ongoing and changing business. This included a “mini portfolio management” process to assess the future quality management needs for new products against the processes being designed within the program.
Mindavation’s coaching efforts commenced after program design was completed and continued for the life of the project. Effort was also focused on controls and stakeholder management to:
- Ensure progress was made toward enabling common practices across geographies. Vital to this was the establishment of Centres of Excellence. These CoE’s were instrumental in helping ensure scope was not being taken away from the geographies, rather, expertise was being cultivated, recognised and leveraged.
- Sponsorship – via the program managers and the Steering Committee – was being performed appropriately.
- Prepare and support employees to execute new quality testing processes, performed in accordance with new centralised result capture approaches (QMS).
- The program exceeded all stated goals, and was expanded to assist unplanned new product introductions early in the program lifecycle
- The Centres of Excellence were put in place and have not only increased efficiency, but derived new and improved testing approaches that have been applied across all engineering units worldwide
- The success of the program resulted in changes to the company’s organisation, with a VP of Worldwide Quality role being created to ensure ongoing holistic management of quality practices across all geographies.
Haydn is a skilled project manager and business analyst with an excellent understanding of business process mapping and data modelling. His proposal to introduce Mavim rules to document our data management processes demonstrates his ability to identify gaps and build a road map to plug them.