Key Surgical recently announced a merger with Interlock and Clinipak, two European market leaders that also focus on products for the OR and sterile processing/central service departments. The merger has created a global provider in sterile processing and OR supplies. The three companies, which will continue to operate under their existing names, have highly respected brands, and are regarded for their expertise, broad product offering and exceptional customer service.

“Our merger allows us to offer hospitals and surgical centers a much broader portfolio of products and supplies; supporting the dedication to patient safety both in the OR and in instrument reprocessing,” Key Surgical Marketing and Communications Manager Alana Suomela explained.

OR Today magazine interviewed Suomela, Kasey Koenig (Regulatory), and Lindsay Brown (Clinical Education Manager) to find out more about Key Surgical and what customers can expect as the company provides solutions amid continued growth.

Q: Can you share a little bit about the company’s history and success?

Suomela: Key Surgical was started by three women in 1988 who, having years of combined experience in the health care industry, saw a need for a one-source supplier of high-quality, sterile, ready-to-use products in the operating room. Soon after, they saw the opportunity to expand the business to include products to clean, protect, and identify surgical instrumentation throughout the decontamination and reprocessing process. A one-stop shop paired with excellent, second-to-none customer service proved to be just what hospitals and surgery centers across the U.S. needed to maximize efficiencies in supply chain by ensuring surgical supply needs were met in a timely, cost-efficient manner.

Key Surgical became the “one to beat” in the marketplace. In 2005, Key Surgical was acquired by Brian O’Connell and Scot Milchman who, like the women who started the company, were long-time friends and professional peers in the medical device industry. Brian and Scot grew the business of Key Surgical on the principals set by the founding women. As the number and complexity of surgical procedures increased year over year the need for a wider variety of products to clean, identify, protect, store, and transport surgical instrumentation grew. The brand evolved to what it is today; a company that holds true to its roots in high-quality products and exceptional customer service. Their combined focus on growth and always doing the right thing for customers comes natural. One might even say that “the apple doesn’t fall far from the tree” as one of the founding women is Scot Milchman’s mother, Gail.

Today, Key Surgical serves nearly 10,000 hospitals and surgical centers around the world. Key Surgical employs customer-facing teams such as customer service, sales, and marketing that are laser-focused on providing solutions to the operating room and the sterile processing/central service department. Combined with a robust operational infrastructure at the headquarters in Eden Prairie, Minnesota, are internal quality and regulatory, supply chain, finance, contracts, and clinical education departments. Key Surgical truly stands behind its mission statement: Grow by providing the quality products, value, and service that our customers want, when they want them.

Q: What are some advantages that your company has over the competition? 

Suomela: Key Surgical’s focus on the customer experience gives us the incredible opportunity to remain the market leader for sterile processing and operating room supplies. During business hours, customers call Key Surgical and get a live person right away on the phone, not an automated machine. The customer service team is trained on product and process; their ability to shape the customer journey is something we value greatly at Key Surgical because we know our customers expect it and we know they deserve it. We talk about value and service but we truly live and breathe it through our ability to manufacture our own products which allows us to closely monitor the quality. We offer same-day shipping, allow customization of many of our products, have the widest range of sterile processing products on the market today, and provide valuable tools to the hard-working professionals in the industry by way of education. In the past year, Key Surgical has hired a clinical education manager and developed an education program for our customers. Certification in sterile processing requires a certain amount of continuing education credits (CEUs) each year to maintain the title and the CEUs designed by the clinical education manager are invaluable training material to anyone (certified or not). The CEUs have been presented in a number of ways; in person at educational conferences around the country and they are accessible our company website. The CEUs are both IAHCSMM and CBSPD certified.

Q: Please share some company success stories with our readers – one time that you “saved the day” for a customer.

Brown: We are a resource and trusted partner for our customers and this is a valued benefit when hospitals undergo TJC or CMS inspections. Often times, our sales team members answer product-related or IFU questions that inspectors have once they are on-site. In one specific instance, an inspector was dissecting the policies and procedures in a Sterile Processing Department decontam area of a hospital. The week prior, the sales rep had completed a cleaning brush assessment and helped implement a manual cleaning policy for this hospital which included training of all staff members so that regardless of who was asked questions by an inspector everyone knew how to answer correctly. This led to an impressed inspector and an endlessly grateful customer.

Q: What are some challenges the company has faced?

Koenig: The medical device regulatory environment is constantly shifting. The pressures imposed on medical device manufactures to produce safer devices with more verification and validation steps that are cost effective is increasing. In this past year alone, the new quality management system standard ISO 13485:2016 was released, along with the Medical Device Single Audit Program (MDSAP), FDA Unique Device Identification (UDI) Compliance for Class II devices was required and, most recently, the MDR (European Medical Device Regulation) was published. The challenge lies in the logistics of updating your quality management system to meet regulatory requirements of multiple countries with different deadlines. Key Surgical has been able to overcome that challenge by implementing an early adoption approach to certain standards and regulations. For instance, Key Surgical began preparing for UDI in 2013 when the original drafts were published and we most recently received certification to ISO 13485:2016 (compliance isn’t mandatory until 2019). Staying on top of industry quality and regulatory requirements allows us to quickly adapt to the environment while producing safe and effective devices.

Q: Can you explain your company’s core competencies? 

Suomela: Key Surgical goes beyond just being a vendor. We focus on fostering collaborative relationships with customers to become a partner and we do this in a number of ways. One way is the development of in-person and online education/training opportunities; ensuring that they are following standards and recommended practices with a focus on patient safety through effective decontamination and sterilization methods. Customers can earn CEUs from Key Surgical through our online program, during an in-service at their facility, and at regional and national conferences. Our customer service team is cross-trained on products and resources so that customers can quickly get any information they need in order to make a decision on a product, or access product information such as instructions for use (IFUs). In addition to having documentation such as IFUs easily accessible on our website, we work closely with oneSource Document Management Services, the world’s largest complete online database service of manufacturer’s IFUs, to also ensure that the documentation our customers seek is readily available and always up-to-date. Many of our customers access this global database on a daily basis for their various documentation needs. We are dedicated to being where our customers need us – whether that means with product solutions, IFUs or educational opportunities. Flexibility is key when it come to our customers’ needs – we offer customization of many of our products to fit the varying needs in SPD and the OR. We allow customers to purchase products from us without requiring minimum orders and we also offer bulk packaging for customers who wish to do so. We also partner with various group purchasing organizations (GPOs) to help customers meet their contract compliance needs. Key Surgical also has a certified quality management system that allows us to stay committed to producing the highest quality products in the medical industry by meeting customer and regulatory requirements. Also, our QMS allows us to continually improve our products, processes and systems.

Q: Tell us about the company’s facility?

Suomela: Key Surgical is located in Eden Prairie, a suburb of Minneapolis. Our headquarters is a 70,000 square foot office building, nestled in a beautiful, wooded area. Our facility also features an ISO Class 7 cleanroom, where select OR products are prepped for sterilization before sale.

Q: What should we know about your employees?

Suomela: Part of our mission is to hire and retain good people who understand that nothing happens until a customer decides to do business with us. Everyone here understands the impact our products have on patient safety in terms of positive surgical outcomes and reducing patient risk. We require all of our sales team members to be IAHCSMM vendor certified (CCSVP) and all new hires are cross-trained in various departments to gain a full understanding of how essential each department is to the overall success of Key Surgical. Each Key Surgical team member brings a wealth of knowledge and experience and their everyday contribution to our mission is “key” to how we operate and deliver on promises to our customers.

Q: What is your company’s mission statement?

Suomela: We believe that nothing happens until a customer decides to do business with us – meaning that every single Key Surgical employee is vital to the success of our company through their role in the customer experience. We do this by first hiring and retaining good people. Next, we focus on growth through providing the quality products, value, and service that our customers want, when they want them. Finally, we believe in giving back to our community in which we operate through volunteer and donation efforts.


To find out more about Key Surgical, visit www.keysurgical.com.