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Change is like lightning, then thunder. If we see the lightning and hear the thunder, we have time to react. Most orthopaedic industry professionals agree that the industry is in for some major changes, which are being driven by a push for better patient outcomes, industry consolidation and pricing pressures.
In adapting to these shifts, we can learn from other industries—airline, automotive, banking—that experienced major changes in recent decades and saw the lightning strike, but didn’t react to the thunder. Take the automotive industry. It had ISO 9000 to control manufacturing. It had ISO 13485 to control quality. It had managers and bankers looking over its shoulder. What could go wrong?
They weren’t using a unified plan to manage day-to-day financial success. Industry managers around the world had plans. Banks had plans. Employees were implementing these plans. Everyone got up in the morning, turned the key, hit the gas and went. The problem was that everyone was using different cars and different road maps. Coming up with a unified plan that works in an industry with complex goals, banking systems, work standards and multilingual challenges is not easy. However, it’s essential.
What do all companies have in common? The need to bring value to customers. Success in doing so translates to company value. Managing risk and opportunity is the best way that companies, including those of us in the orthopaedic industry, can add value to our businesses. Value can be measured by how well we handle our assets, whether physical, financial or human. It’s critical to develop a unified plan to manage your day-to-day financial success.
Where can we find such a plan that will lead to cost reductions that directly add to the bottom line?
The answer is the set of ISO standards released in January 2014: ISO 55000, 1 and 2 for asset management. These standards comprise three components:
- The Why: ISO 55000 Overview, Principles and Terminology
- The What: ISO 55001 Management Systems – Requirements
- The How: ISO 55002 Management Systems – Guidelines on the Application of ISO 55001
ISO 55000 evolved from PAS (Publicly Available Specification) 55 and offers CEOs, CFOs and operations managers a unified plan to manage success on the asset side of the business model, similar to the ISO 9000 and ISO 13485 standards on the manufacturing side. Asset management with ISO 55000 allows companies to fund a fully-developed plan that will create cost reductions that can fall directly to the bottom line.
ISO 55000 adherence drives alignment of processes and resources, allowing companies to shed departmental silos and narrow focuses on short-term priorities, create a transparent audit system and understand and employ data to make informed decisions, among other benefits.
More than two dozen countries, including those with the largest orthopaedic industries, are full participants in ISO 55000, and the standard is gaining traction amongst companies in those previously-mentioned industries that are seeking a unified plan.
Let’s go back to the coming storm. Think of this discussion like the raindrops that precede the storm. First, the forward thinkers and those who want to get ahead of the competition will review this standard. A few early adopters will start implementation. Then the followers will start pouring in. The orthopaedic industry is undergoing changes worldwide. Learn from the mistakes made by other global industries. Don’t get caught in the downpour.
Exhibit 1: Medical Device Industry ISO 55000 Implementation through 2020
ISO 55000 was released in 2014 and is expected to be adopted and implemented by 60 percent of medical device manufacturers by 2020, as shown in Exhibit 1.
Randy W. Rapin has worked in design and process manufacturability since 1965. He founded RLTIndustries in Dayton, Ohio in 1995. RLTIndustries offers design and process manufacturability services to the orthopaedic and automotive industry. Mr. Rapin has extensive experience in metal, plastics and rubber component design. He now offers biomechanical design and engineering support to the orthopaedic industry, with a current focus on spinal implants. RLTGold, a division of RLTIndustries, opened in 2015 for the implementation and training of ISO 55000. Mr. Rapin can be reached by email.
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