Established in 1978, UTMD began as an entrepreneurial

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2 2 Written by Jessica Ferlaino For 40 years, Utah Medical Products, Inc. (UTMD) has established a stable market presence as a trusted medical device manufacturer. UTMD develops and manufactures safe, reliable medical devices for use in gynecology, labor and delivery, neonatal critical care, electrosurgery, urology and invasive blood pressure monitoring. Established in 1978, UTMD began as an entrepreneurial entity that spun off from another medical device company. Over the years, it has added to its capabilities through expansions and key acquisitions, growing its product offerings and its market presence to span the globe. Headquartered in Midvale, Utah, UTMD does business within over 100 countries and has a manufacturing footprint in the U.S., Ireland, and England. Its medical devices are sold directly to end users in these markets as well as in Australia and Canada where it has distribution facilities. UTMD serves other international customers through a network of 270 distributors outside the U.S. and original equipment manufacturers (OEMs).

3 3 As of 2018, UTMD had 110,000 square feet of facilities in Utah, 77,000 square feet in Ireland, 38,600 square feet in England, 3,200 square feet in Australia and 4,700 square feet in Canada. UTMD s manufacturing facilities are ISO certified and in compliance with the U.S. Food and Drug Administration s (FDA s) cgmps. UTMD supplies other medical device companies around the world with its standard electronic and plastic components and assemblies, as well as subcontract manufacturing services that leverage its expansive in-house capabilities. From silicone injection molding, insert and over-molding, electronic component packaging, bonding and ultrasonic welding, component surface printing, thermoplastic injection molding, specialty extrusion, automated assembly, custom packaging and labeling, thermoforming, mold-making to clean room assembly, the company is well equipped. UTMD got its start in hemodynamic monitoring, and built upon those products to develop expertise in other clinical specialties. Gynecology is now its strongest clinical segment with the greatest growth potential. CEO Kevin Cornwell explained how the transition took place. Innovation has been a very critical component of UTMD s success and it is achieved through a consultative approach

4 4 with clinicians. The initial blood pressure monitoring concepts were applied to pressure monitoring in labor and delivery, addressing the need for accurately monitoring contraction intensities inside the womb for purposes of controlling the administration of oxytocin, used to manage active labor. This cannot be achieved with an external toco which only indicates when a contraction starts and stops. This seminal device named INTRAN opened the door to other labor and delivery ideas, and led to the related field of gynecology. UTMD s product development takes many forms including improvements, enhancements and extensions of existing devices to meet the changing needs of clinicians, the introduction of devices that improve safety, effectiveness or total cost of care, as well as acquisitions of products and technology. By consulting with the clinicians that rely on its products, UTMD develops an inherent understanding of the needs and challenges clinicians face and can better develop and manufacture products or communicate the many advantages of its existing product lines to provide solutions that address those needs. We try to improve on things and come up with something that s differentiated and yet not have to spend millions of dollars on clinical trials for a device which might have $5 million annual total market potential, said Cornwell. With the limitations to market access in this industry, a small company with a single product finds it very difficult to be able to afford to supply its users directly, which is important to our strategy of responding to the needs of clinicians. UTMD s early successes in pressure monitoring allowed a financial base that was solid enough to start marketing directly to medical facilities and becoming a recognized leader by clinicians, said Cornwell. Rather than taking a commodity product market strategy, UTMD s approach is to focus on niches, integrating its resources and capabilities for addressing specific patient safety and procedure effectiveness needs that were previously unmet. UTMD is always focused on the development and introduction of new and innovative products. The objective is to have a clinically safe and effective, manufacturable and regulatory-released product ready for market that is reliable, easy to use, cost-effective and differentiated from other alternatives in the market. Process development is often as important as product development in achieving this objective. In this industry, hospitals are very focused on cost and that drives medical device suppliers to be commodity-oriented. We ve resisted that in order to provide devices that achieve optimal long-term outcomes, avoiding or reducing complications, which is not just minimizing out of pocket costs of a device but the total cost of care, said Cornwell. The total cost of care takes into consideration complications, side effects, utilization rates and overhead costs. As Cornwell noted, When a medical practice or hospital experiences a serious injury or an unwanted outcome, they can spend an awful lot of resources on considering what may have gone wrong in order to correct it, not to mention defense in malpractice lawsuits. If they can avoid those types of things, it certainly has a big impact on the total cost of care. UTMD s products are proven reliable and offer numerous clinical advantages. The company has the proven ability to integrate engineering and technical disciplines in electronics, software, mechanical packaging, instrumentation, plastics processing and materials to improve patient safety, clinical outcomes and costs through labor-savings, improvement in clinical procedures and ultimately, an improvement in overall healthcare delivery.

5 5 Training in vertically-integrated manufacturing plays an important role in UTMD s ability to deliver results for clinicians and hospitals around the world. Training is a huge part of making reliable devices because in this industry, experience with subtle process techniques is important, and everything has a written procedure which must be carefully followed, explained Cornwell. The design of the products themselves is important, but just as important is the ability to produce a device which works as intended, he said. If you re making the product for yourself, your engineers can go down to the manufacturing floor, right to where the products are being manufactured and see what s going on, in order to ensure quality in every device, every time. UTMD has held dozens of patents, both in the U.S. and internationally, as well as multiple registered trademarks which have bolstered the company s reputation and brand recognition in the market. While there are many examples of UTMD s exceptional product offerings across specialties, one of the most notable is the Sterishot Single Use Filshie Clip System, which Cornwell described as, The leading permanent surgical sterilization device, in use for 30 years. People recognize the name all over the world. The Filshie Clip is named for the physician who originally conceived of the device and is a U.S. FDA Class III device which is subject to the most stringent regulatory controls. The company s goals for 2018 include the further integration of its capabilities and resources across its global footprint, further synergizing the distribution and manufacturing capabilities at each of its locations and across its distribution networks. A small but impactful company, Cornwell noted, We reject the conventional wisdom that getting big is a desirable thing to do. The reason for that is we want to stay focused and responsive to our customers needs and that s what makes our business stable and predictable, which in turn helps keep our people at the company. To this end, UTMD continues to identify strategic acquisitions and growth opportunities that will further advance its mission to design and manufacture high quality, safe, effective, reliable and cost-effective medical device solutions that improve patient outcomes and clinical procedures. UTMD was borne out of efforts to address challenges and gaps in the marketplace and as such, it will continue to innovate through the design and manufacture of medical devices, components and assemblies that meet the needs of clinicians and hospitals around the world. Plastic Molded Concepts is a plastic injection molding company with diverse experience in all resins. One of our specialties is engineering grade resins. PMC has robust capabilities in plastic injection mold design assistance with our chosen tooling facilities speciic to your needs. We serve a variety of industries capable of delivering your mission-critical parts. Call us for a Quote!

6 7043 South 300 West, Midvale, UT P: F: SUPPORTED BY PLASTIC MOLDED CONCEPTS As featured in July 2018