Entering the U.S. market means compliance with the US Food and Drug Administration and international quality standards. While the products might be fine, the processes behind them may not be as robust as needed to comply, as a leading New Zealand medical device company, Medifab found.
Medifab’s products make a positive difference to the lives of persons with a disability through the provision of leading edge postural support solutions for a wide range of special needs. It offers more than 130 products which include everything from wheelchairs, standing aids, beds and bathroom aids through to strollers and pushchairs, indoor seating, car seats, and harnesses.
It operates in a highly-regulated industry and the company must comply with significant quality systems and regulatory requirements to meet its customers’ needs. These requirements ensure that Medifab consistently designs, produces and markets medical devices that are safe and effective for their intended purpose.
Stuart Clook, Quality and Regulatory Affairs Manager, Medifab, said, “We’re expanding internationally and storing processes and standard operating procedures in various static formats such as Excel and Word was increasingly holding the business back from its full potential.”
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“Not only were these processes difficult to manage but they also fell out of date easily and were often misunderstood by staff. At the end of the day, there is little value in a procedures manual that nobody looks at or updates. To future proof and facilitate our future business growth, we knew that all our staff had to be on the same page operating and managing processes that are simple and easy to understand,” said Clook.
Add to that the latest revisions in global quality standards and regulations have mandated an increased emphasis and focus at Medifab to identify and manage its product and business risks.
Medifab went to the market for a solution which would support the organisation’s ability to meet the requirements of the global market. A business process management (BPM) tool would also support the creation of the right culture and structure to support the transition of the business from a service-based company to a global manufacturer. Innovation and product development would, in turn, need the support of sophisticated processes which could be easily understood and maintained by everyone in the business.
“We looked at several solutions and concluded that Promapp offered more than just a compliance and risk tool, it could also be our core solution for ongoing business process improvement. Having compared its feature functionality against our existing programs, it was easy to see that our staff would be able to easily create, maintain and share processes. Importantly, we would be able to reduce costs in some parts of the business while meeting our commitments and responsibilities to our customers and regulators worldwide,” said Clook.
Since implementing Promapp throughout the business in September last year, Medifab has published 42 new processes and actioned over 300 improvements. This has significantly raised the level of collaboration among different teams and helped the company to improve performance to meet customers’ expectations while setting it up to start the formal ISO 13485 certification process.
While Medifab currently uses ISO 14971 (Medical devices -- Application of risk management to medical devices) as a key component in its business and product development processes, Promapp’s Risk Management module and associated workflow make this requirement straightforward to manage and administer.
Medifab is also using Promapp’s Improvement module to record and manage customer feedback, complaints, internal non-conformances, engineering change requests and opportunities for improvement. Promapp’s built-in workflow allows users to easily manage and monitor the timely closure of these opportunities and incidents.
In addition, being a cloud-based system means that Promapp is accessible from any device in any location. It can also integrate with other systems which make the investment in processes sustainable. At the same time, sharing processes through their ERP and CRM systems promotes higher frequency viewing of processes.
Clook said, “Ultimately, processes should be easy to manage and update for all staff, not just technical specialists. The use of pictures and videos for hands-on processes, as well as integration of risks throughout a specific process, engages staff and leads to continuous reviews and improvements, eliminating the costly, time-consuming cycle of large-scale ‘catch up’ initiatives needed every few years. Automatic version control and change notifications not only save time and effort for audits they also make sure that the improvements made from efforts such as ISO 9001 translate from paper to real life.”
“As an organisation, our mission is to make a positive difference to lives of persons with a disability, therapists, and carers. Promapp has made a positive difference to our staff. It has been readily embraced by our 60 staff and smoothed the path for growth across all operations. It's a perfect vehicle for continuous improvement and ongoing capturing of new and updated processes,” said Clook.
