CI Medical Cuts Into the Health Care Industry
by Amy Bauer
CI Medical of Norton, MA, touts itself as the only ISO 9001:2008-certified strictly transfer pad printing company in the United States catering exclusively to the medical device industry.
CI Medical developed its own proprietary ink line to make markings on medical devices "visible" within the body when viewed by X-ray or fluoroscope.
CI Medical works with engineers from the beginning phases of design through the products' life cycle as these products transition out of R&D and proceed into production.
Transfer pad printer CI Medical, Inc. was founded 30 years ago as Creative Imprints, Inc., with a focus primarily on the advertising specialty and sporting goods industries. However, a major shift early on set a new, prosperous course for the company into the medical device market.
Today, CI Medical of Norton, MA, touts itself as the only ISO 9001:2008-certified strictly transfer pad printing company in the United States catering exclusively to the medical device industry.
President Marc Cohen founded the company in 1985, and today he and Chief Executive Officer Clifford Garnett co-own CI Medical. When Garnett joined the company in 1989, the two crafted a business plan that identified new markets and opportunities. Chief among them: the medical device industry.
Cohen had done some earlier work with Boston Scientific, which at the time was looking to outsource all of its printing requirements. "The more we looked at the medical device industry, we realized that it not only was a good market for us to pursue as it related to the growth of our business, but it also was an appropriate market as it related to the attributes transfer pad printing provides: exacting precision and unparalleled quality," Garnett said, noting that the high volumes of single-use items in this sector proved an attractive opportunity.
"All of the jobs that we were going to be involved with represented annuities to us, with constant reorders of single-use-only product lines distributed in the marketplace," he said.
Boston Scientific was integral in helping Creative Imprints, Inc. transition to what would become CI Medical, Inc. It helped the company with the steps required to become an approved vendor and meet the requirements of Total Quality Management (TQM), even sending quality engineers to the print facility to assist with the transformation, Garnett said. "They said, once you become an approved vendor for Boston Scientific, the good news is that then you can market to other medical device companies in the industry," Garnett said.
By 1995, 100 percent of CI Medical’s marketing and manufacturing was geared to the medical device industry. Today, the company’s customer base includes not only a number of Fortune 500 companies, but also many start-up and maturing medical device OEMs, printing on thousands of product lines, marking catheters, ports, needles, connectors, syringes, textiles, heat shrink, stainless steel and Nitinol tubes, among other components. It works with such substrates as PTFE, PE, PU, silicone, Delrin, Pebax and Nitinol, to name a few.
"The functional designs that we print on the components range from 360-degree band markers to numbers to company names and logos for passive advertising," Cohen said.
Many of the device components CI Medical works with are printed with the company’s proprietary Radiopaque® inks for use within a fluoroscopy and/or X-ray environment for short-term, long-term and permanent implants.
CI Medical developed its own Radiopaque® ink lines and its related transfer pad printing techniques over a number of years of research and development, and Cohen credited Engineering Manager Bruce Mahan for fine-tuning these inks in the past few years. The inks make markings on medical devices "visible" within the body to medical professionals when viewed by X-ray or fluoroscope, allowing assessment of proper positioning and placement or identification of the particular device.
Components that utilize this ink include pacemakers and chemotherapy ports, as well as tubes, fabrics and polypropylene sheets used in stent-less and/or spinal procedures.
"The ink has taken off," Cohen described of customers’ demand for the product. "We pad print literally hundreds of thousands of pacemakers and ports, along with catheters and a number of medical fabrics and devices. It turned out to be a very exciting niche which none of our competitors have."
Most recently, working with one of its suppliers, CI Medical developed a Radiopaque® ink that will adhere to silicone, one of the few substrates to which its original Radiopaque® inks don’t adhere.
CI Medical at a glance
The small but nimble CI Medical employs 20 people at its 20,000-square-foot facility in Norton, which is midway between Boston, MA, and Providence, RI. Most employees have been with the company for 10 years or more. Its work force includes a quality department led by a quality assurance manager and dedicated quality inspectors.
The current facility was designed and built in 1998 to meet the strict requirements of the medical device industry. CI Medical maintains a bio-burden-limiting clean environment, which includes a requirement for all production personnel to wear gowns, bouffant headwear and non-latex gloves when on the production floor and handling customer product.
The company was an early adopter of ISO certification, which it first obtained in 1999. While the company at the time heard from a majority of its customers that, as a secondary tier level vendor, such a step wasn’t necessary, the owners saw it as a way to improve the functional management of the business. Today, such certification is a requirement for any company working in the medical device industry.
CI Medical runs a single-shift operation that is capable of expanding as needed – to a shift and a half or double shift – depending on the current mix of production requirements. Volumes range anywhere from the production of single prototypes during product development to low-seven-figure production runs, and all volumes in between.
The company specializes in finding solutions for tough printing configurations and new, cutting-edge products. It has built its business by cultivating the trust of design engineers at the medical device OEMs and positioning its employees as problem-solvers. Much of the company’s work is kept strictly confidential because it involves product lines moving through the research and development and early production stages. Confidentiality and nondisclosure agreements are utilized with CI Medical’s customers to ensure everyone’s understanding of the relationship between the OEM and a key vendor.
"We partner with design engineers of transfer pad printing machine manufacturers from around the world. With our vast pad printing knowledge and experience base, coupled with their machine capabilities, we have jointly designed machinery that provides printing capabilities that no other company can duplicate," Cohen said.
The company has invested in technology to create a paperless environment for its document storage and retrieval system. This not only promotes great customer service, Mahan said, but also meets clients’ document retention requirements. The system also provides the backbone for CI Medical’s disaster recovery program.
"CI Medical has been ‘cloud computing’ for years, which has generated many efficiencies," he said. "These are all reasons why we attract customers within the medical device industry. We take their needs and requirements very seriously and have invested heavily throughout our history to meet them."
The single-industry concentration allows CI Medical to laser-focus on the skills and innovations that will be relevant to its particular customer base. As with any industry, the medical device industry has undergone changes over the years. For example, many of the OEMs moved to Ireland 15 to 20 years ago to take advantage of low labor costs and government-backed tax incentives, as well as a highly educated workforce. In the past five years, Garnett said, many of those companies now have moved operations to Costa Rica for some of those same reasons.
CI Medical is somewhat insulated from the pitfalls of focusing efforts on a single industry, its owners noted. "Every once in a while, we’ll bolt up at 3 a.m. realizing that we’re fully concentrated in one industry, but the thing that helps us through that sleepless night is the fact that we’re so well diversified as far as not only the number of companies that we provide our services to, but more importantly the number of product lines, which are in and of themselves each an individual business opportunity for us," Garnett said.
"That grows every day, and that mix changes year to year," he said. "We start with the new design engineers at the very beginning phases of new product design, wanting to get in on the ground floor of the build. And then, as these product lines go through their life cycle, they transition out of R&D and proceed to the production side of their companies. We ride those volumes as they hopefully expand as the product line gains acceptance in the marketplace."
Also, even when economic times tighten, budgets for new product innovation in the medical device industry typically aren’t adversely impacted as new product designs represent the future of the medical device OEMs, Mahan said.
Several strategies are used as part of a multi-pronged marketing approach by CI Medical to target the design engineers at medical equipment manufacturers. Mahan said one of the first places engineers often go when looking to solve a design problem is the Internet. CI Medical has invested its resources in search engine optimization (SEO) strategies that ensure the CI Medical website, www.cimedical.com, appears at the top of all web results when a medical device design engineer searches key words and phrases.
Mahan said the company works with a marketing firm to ensure its web presence and search engine results are top-notch. The company’s website is thorough but not overly complicated, Mahan noted, to ensure that visitors quickly can find the information they need. A "What’s New" section offers updates, latest news and upcoming trade show dates, keeping content fresh and relevant.
The company exhibits at the major medical device manufacturers (MDM) and biomedical shows that are staged multiple times a year throughout the US, though Mahan said fewer new leads are coming from these shows in recent years. Now, the company’s participation is more about maintaining and solidifying current relationships.
Cohen and Mahan also spend time throughout the year traveling to visit current and potential clients to offer one-on-one attention. They hold "brown bag" sessions over lunches and will present samples of CI Medical’s work on different challenging substrates.
"The samples not only demonstrate the quality of our printing process, but also the superior adhesion we achieve," Mahan said. "We may have an audience of two, or we may have an audience of 10. Generally, you’ve only got that one shot to show them that you know what you’re talking about and that you can satisfy their requirements and potentially meet their future needs. A lot of times, they don’t have a need at that point, but you want to make sure that when the need arises, you’re the first one they think of."
By tapping into the design engineers with whom CI Medical already has established relationships and expanding through word of mouth recommendations, the company has grown its contacts. "Once you help an engineer in a problem-solving situation, you’ve got a friend for life," Mahan noted.
CI Medical has won several quality awards from its customers, as well as dock-to-stock privileges on a number of product lines that it prints for customers. Exploring new ways CI Medical can work to enhance the relationship with its OEM customer base always is foremost in managers’ thought process.
As an example, a number of customers have instituted a Kanban relationship with CI Medical. Kanban is a system to control the logistical supply chain from a production point of view. CI Medical has embraced this concept and eagerly participates in this type of program to solidify its relationships with OEMs.
"Medical device design engineers continually are pushing the envelope on developing specialty substrates that allow surgical instruments to perform in a precise fashion. Fortunately, one of the main attributes that most of these substrates possess is the fact that nothing adheres to the surface," he said. "When it is determined in the design cycle that functional markings are required on the device, they access our technology in order to achieve success."
Cohen said he is proud of the positive feedback the company receives from its clients. He said those who visit the company on-site are particularly complimentary.
"They walk away extremely impressed with what they see from a company that’s typically much smaller than the company that they work for," he said. "It gives us positive feedback that we’re doing things the right way."
He said the company always is open to new innovations and encourages its employees to be as responsive as possible to client needs. Managers are in many cases empowered to make decisions on the spot, rather than having to wait for management meetings or other lengthier processes for approvals.
"We’re a service company," Cohen said. "When a customer comes in with a request, we’re never asking, ‘Why?’ Instead, we’re always asking, ‘How high?’ "
"It takes years to perfect the elements that go into the transfer pad printing process," Cohen said, "and we pride ourselves on being able to achieve levels of quality that are superior to anyone else who tries to perform this printing technique."