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Kelmac Group Case Study: Brown’s Medical Imaging Investing in ISO 13485

Brownu2019s Medical Imaging (BMI) is a family-run success story out of Omaha, Nebraska, specializing in the sales and service of medical imaging equipment for over 25 years. They currently operate in 50 states, 3 countries, and have over 140 employees, many of them highly trained engineers.

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Kelmac Group Case Study: Brown’s Medical Imaging Investing in ISO 13485

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  1. A Kelmac Group® Case Study Brown’s Medical Imaging Investing in ISO 13485 Certification, and the Future By Zach Brown, CFO, Brown’s Medical Imaging & Scott Hornstein, CMO, Kelmac Group® About BMI P.2 Beginning the Journey P.3 Was it Worth the Time and Money? P.4

  2. A Kelmac Group® Case Study: Brown’s Medical Imaging Brown’s Medical Imaging (BMI), is a family- run success story out of Omaha, Nebraska, specializing in the sales and service of medical imaging equipment for over 25 years. They currently operate in 50 states, 3 countries, and have over 140 employees, many of them highly-trained engineers. Zach Brown is the CFO of BMI and a second- generation leader. He joined four years ago after a career in corporate auditing, servicing a diverse client base and brings a passion for business optimization and growth. He has graciously agreed to act as the guide through their ISO 13485 certification. BMI’S SOLID REPUTATION IS BUILT ON TWO PILLARS A tradition of personalized customer attention which comes from the core of their business philosophy Providing clients with state-of-the-art products and solutions which deliver quality at a low cost of ownership Copyright © 2023 Kelmac Group® www.kelmacgroup.com ID: KGA-CS-03 | v2.0

  3. A Kelmac Group® Case Study: Brown’s Medical Imaging THE MEDICAL GROUPS AND FACILITIES THAT COMPRISE BMI’S CUSTOMER BASE RELY ON THEM FOR A VARIETY OF SERVICES ANALYTICS SUPPORT ARCHIVAL SOLUTIONS SALES REMOTE MONITORING Installation Financing Training Beginning the journey The rough spots from Kelmac Group’s point of view “We began on the path to ISO 13485 because it was the next logical step in our growth. Plus, the handwriting was on the wall – congressional legislation was about to mandate that third parties would need ISO medical device certification. We needed to get in front of this. In our estimation, compliance with evolving regulations was good, but the competitive differentiation of assuring our customers, especially large prospects, of our standards was even better”. Initially, BMI retained another consultant based on a recommendation. In their words, it was a “disaster”. After spending a year and a lot of money, they found themselves unorganized and basically nowhere. They suspect that the consultant had never accomplished this large an undertaking before. With the legislative clock ticking, they launched an intensive search for a truly qualified organization and found the Kelmac Group®. “Gerard assessed the situation and took the reins. He cleared up the confusion and educated us, not only on how to prepare the paperwork and how to survive an audit, but how to move our organization to higher levels of quality. He established trust early on.” Gerard Kelly, CEO of the Kelmac Group®, offers the following perspective: “There were two intertwined hurdles we had to overcome. The first was proving to management that the real benefit of this process is to the organization and that they should invest in the long term. This focus drives better decision-making; however, the investment is more than intellectual. This is an ongoing job of leadership. “The second, and closely linked, is the culture and traditions of the company. Some employees were there at the start. Many employees had varying ways of doing things, and standardization is the key to a worthwhile QMS. We had to define the correct processes for the company, document them, and train the employees.” “With the legislative clock ticking, they launched an intensive search for a truly qualified organization, and found the Kelmac Group®” Copyright © 2023 Kelmac Group® www.kelmacgroup.com ID: KGA-CS-03 | v2.0

  4. A Kelmac Group® Case Study: Brown’s Medical Imaging The rough spots from BMI’s point of view Was it worth the money and time? Zach offers reality: “Getting everyone on board was and still is a challenge. It requires a lot of communication. We’ve got 90 service technicians, some of whom have been here for 25 years. When we were starting out, we flew by the seat of our pants, and basically, they’re used to doing things their own way. ‘Gerard helped us to see that we are now of a size that we need standardization. He helped us to build the metrics that we live by, that tell us what’s going well and what’s not. Everyone needs to be held to this standard. “The other thing is, we are better, and it costs more operating in an unorganized way.” “Absolutely.” BMI benefits realized: 9 ISO 13485 certification last May 9 Greater standardization and higher quality 9 A (new) large national account (certification was a requirement) - increased revenue by 5% 9 Improved hospital compliance with State/Federal Regulations, i.e. 21 CFR 820 9 All installations performed to MD OEM standards. 9 Helping hospitals to provide better patient safety and care by ensuring MD Equipment is 100% maintained and available to hospital clinical teams 9 Improved profit by 15% A final word – Trust “Would I call the Kelmac Group® back in? Absolutely” –Zach Brown Per Zach: “Trust is essential to this successful relationship. We trust Gerard and the Kelmac Group®. Part of this is their extreme responsiveness. Frankly, I’m not sure when Gerard sleeps.” “The Kelmac Group® set us up to be self- sufficient. We know that things were pretty messy before and that we need to improve, but we’re on top of it. “Would I call the Kelmac Group® back in? Absolutely. Would I recommend them? I have. Would I refer them? I have. No question.” Copyright © 2023 Kelmac Group® www.kelmacgroup.com ID: KGA-CS-03 | v2.0

  5. A Kelmac Group® Case Study: Brown’s Medical Imaging Contributors Zach Brown Scott Hornstein Zach Brown is a CPA with a background in corporate auditing for a diverse client base, and a passion for business optimization and growth. He joined Brown’s Medical Imaging in Omaha as CFO in January of 2019. He also has a passion for Aviation and is a pilot. International author, lecturer and consultant, Scott has worked with clients in all phases of marketing strategy, research and implementation. He has worked with companies large and small to introduce and build new ideas to profitability, improve marketing performance and accountability, and re-engineer the customer experience to boost satisfaction, referral and customer lifetime value. Copyright © 2023 Kelmac Group® www.kelmacgroup.com ID: KGA-CS-03 | v2.0

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