Auer Medical: At the Vanguard of Medical Diagnostic Device Manufacturing
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Mike Lolli, CFO, Brent Bollong, President and Nick Campbell, Operations Manager The introduction of disposable, electro-chemical blood glucose test strips was a game-changer in the history of diabetes monitoring and treatment. By democratizing access to quick and easy blood sugar level testing, these strips allowed individuals to keep track of their condition, even from the comfort of their homes. Billions of these strips have been manufactured ever since, enabling speedy treatment and recovery of countless patients across the globe. While it is one thing to come up with such a novel medical diagnostic product, it is a different ball-game when it comes to manufacturing them. The quality and standards mandated by such medical diagnostics devices cannot be compromised for the sake of quick turnaround times. This is where Auer Precision imparts its value through comprehensive manufacturing solutions for the medical and life sciences industry. The company offers turnkey solutions to help manufacture medical devices without compromising on quality. Auer Precision positions themselves as a one-stop-shop for the design, prototyping, manufacturing, material sourcing, and supply of innovative medical diagnostic devices.
Long before its entry into the medical diagnostics devices space, Auer Precision established (and continues to hold) its legacy as a provider of precision parts and components manufacturing, stamping and tooling, and contract manufacturing services to several Fortune 1000 companies. In many ways, the diabetic strip boom in the market was a turning point in Auer’s journey. Having discovered their mettle in catering successfully to one strip maker, Auer Precision—in a bid to make more out of its contract manufacturing expertise and resources—decided to strategically enter the medical device manufacturing space. Today, the company is an experienced contract manufacturer of diagnostic strips, medical components for non-invasive surgical devices, and system-critical components for analytical equipments. Auer Precision’s competency lies in its ability to stamp (die-cut) channels and registration features in multi-layer laminated materials at micron-level tolerances—100 times more accurately than its competitors. In addition, Auer’s offerings include machining, precision grinding, automation and metrology systems, and developing stamped and assembled components.
Auer Precision’s differentiation lies in the cutting-edge precision that they deliver. “Consider Auer Precision when laser cutting or other conventional methods of die-cutting reach the threshold of their tolerance and accuracy,” mentions Brent Bollong, President of Auer Precision.
The company also has expertise in metrology, and they work as a third-party measurement house for many of their big clients. Auer Precision also houses a full-fledged microfluidic application laboratory to assist clients with product development, prototyping, and process optimization. After all, microfluidic devices like medical strips are widely used for applications such as diagnosis, blood sampling, and cell counting, among others.
With our design and engineering capability, we can get in very early with a client and help them work through the tooling issues and early product issues
Addressing Today’s Medical Device Manufacturing Needs
Having worked with many Fortune 1000 companies across electronics, automotive, and other industries for over four decades, Auer Precision has built the infrastructure and expertise to move in pace with its clients’ requirements. “With our design and engineering capability, we can get in very early with a client and help them work through the tooling issues and early product issues,” adds Bollong. The company also holds expertise in design validation, risk management, and material and supplier selection. They work directly with clients to address the production process development issues and even answers the “hows” of long-term product manufacturing. All of Auer Precision’s technology infrastructure and processes adhere to FDA and other regulatory mandates.
Auer Precision adopts a “validation-centric” approach to the entire lifecycle of medical diagnostics device manufacturing, where the company scrutinizes the development of the device along every step of the manufacturing. When clients are ready to enter the real production phase after the design, validation, and testing of products, Auer Precision offers its complete production suite. As the volume of production grows, the company provides continuous improvements to lower the cost of manufacturing and achieve higher throughput. This extends all the way to the management of suppliers. They document and develop every step in manufacturing for their clients. For attaining quick turnaround times in delivering the medical device or its components, Auer Precision also brings in semi-automation of the manufacturing process, and even automation builds of production equipment. For clients, this removes a common convention of having to wait for weeks to get the product prototypes or first batches.
Most often, Auer’s clients may have a design, an idea, or a device prototype for clinical studies.
Even at this stage, the company envisions the products’ mass manufacturing and puts in strategies accordingly. Auer Precision shows its clients how designs can be improved (strictly within the stipulations) and checks whether alternate products can be used. The company has the mettle to be a full tier-1 provider of all upfront materials purchasing, assembly, quality assurance systems, and the production builds with all required documentation. “We can assist our clients holistically and give them the much-needed ‘vision’ for manufacturing,” adds Bollong.
Exemplary Success Stories and Promising Roadmap
Auer Precision is involved in over 150 new product designs every year. Inevitably, as Bollong says, the medical diagnosis devices space is going through a renaissance in terms of innovation. Several revolutionary products are coming up. To this end, the company involves in elaborate discussions with their clients with regard to the “chemistry” of development processes, biological coding, and mechanical assemblies.
"We have created manufacturing and quality systems that meet our needs as well as the variable nature of clients that come to us"
In one instance, a client approach Auer Precision for addressing only the adhesive bonding stage of their design’s manufacture, which was one of the five steps in the product’s manufacturing lifecycle. Subsequently, recognizing the value proposition of Auer’s expertise and approach, the client asked them to undertake the stamping of their “fairly complex design” as well. And in time, convinced by Auer Precision’s dedication, the client tasked them with the whole assembly line processes. “We have been growing that product with the client and incrementally, taking some of the methods which were largely manual and putting either instrumentation or our own designed automation so that we can continue to support the volume as it ramps. We plan to do that continuously for the next ten years,” says Bollong.
Having carved a unique niche in the market, Auer Precision is planning to hone its capabilities to make the manufactured products “data-friendly” at batch production level or even in a serialized manner. The company is developing processes to lasermark universally unique ID (UID) on the manufactured products, and store metrology and equipment data into cloud databases. This aids the investigation into process improvements or controlled storage of device calibration data. “All in all, we have created manufacturing and quality systems that meet our needs as well as the variable nature of clients that come to us,” concludes Bollong.
Management Mike Lolli, CFO, Brent Bollong, President and Nick Campbell, Operations Manager
Description Auer Precision positions themselves as a one-stop-shop for the design, prototyping, manufacturing, material sourcing, and supply of innovative medical diagnostic devices.The company offers turnkey solutions to help manufacture medical devices without compromising on quality. Auer Precision adopts a validation-centric approach to the entire lifecycle of medical diagnostics device manufacturing, where the company scrutinizes the development of the device along every step of the manufacturing. When clients are ready to enter the real production phase after the design, validation, and testing of products, Auer Precision offers its complete production suite. As the volume of production grows, the company provides continuous improvements to lower the cost of manufacturing and achieve higher throughput. This extends all the way to the management of suppliers
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