Medical equipment maintenance managers and technicians carry a hefty responsibility. Their jobs are to maximize equipment uptime so patients – people like you and me – can receive the diagnostic care and treatment needed to stay healthy. Our lives can depend on the success of their work.

That’s no small task given the ever-changing operational requirements and complex nature of equipment like ultra-sound machines, MRIs, x-ray machines, ventilators, and CT scanners. According to the World Health Organization, there are more than 1.5 million types of medical device products on the market (WHO factsheet No. 346).  Countless parts, exacting calibration requirements, and the latest technology incorporated into over a million device types make ongoing maintenance a monumental challenge.

Luckily for medical equipment maintenance managers, all new medical equipment starts its life with a high degree of quality. The US Food and Drug Administration (FDA) has strict standards when it comes to the manufacture of medical devices. Their most current publication, the Medical Device Quality Systems Manual – A Small Entity Compliance Guide, First Edition specifies quality assurance methodology for every aspect of production, ensuring a high degree of operational excellence and top notch equipment.   

Once medical equipment is operational, however, the ongoing maintenance and repair is demanding.  Aftermarket maintenance and repair regulations are also stringent. According to the FDA’s postmarket requirements for medical devices:

 “Medical device manufacturers as well as other firms involved in the distribution of devices must follow certain requirements and regulations once devices are on the market. These include such things as tracking systems, reporting of device malfunctions, serious injuries or deaths, and registering the establishments where devices are produced or distributed. Postmarket requirements also include postmarket surveillance studies required under section 522 of the act as well as post-approval studies required at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application.”

Additionally, the FDA is proposing new regulation requiring a unique device identification (UDI) system to manage medical devices.  The new regulation is intended to improve equipment safety and effectiveness, postmarket surveillance, quality of care and patient safety. The UDI project is being coordinated internationally through the Global Harmonization Care Task Force (GHTF) – now the International Medical Device Regulators Forum. Although generally supported by the medical device community, the resulting regulation may mean some scrambling on the part of maintenance and repair managers and service providers as they seek to accommodate the new bar coding system.  New draft guidelines could be released as early as February 2013.

Medical Device and Diagnostic Industry’s (MD & DIs) Heather Thompson adds some insight on the topic in her post, “Unique Device IDs ‘A Single Source of Truth’ Says FDA Jay Crowley.”  According to Thompson, the “FDA wants industry to start planning now for unique device identification—and the Agency is eager to help.”

Enigma is watching carefully as the new regulation takes shape. We see some striking similarities between the highly regulated, individually tracked aviation industry where we have created solutions for many years, and the evolving medical equipment industry also headed toward individual identification.  For years, Enigma’s InService MRO software has helped aviation maintenance and repair organizations (MROs) individually track, manage and service aircraft in a highly regulated industry.  

Our InService EPC software has also brought our expertise to the medical equipment industry, tracking and supporting the maintenance and repair of medical equipment.  Customers like Toshiba America Medical Systems (TAMS) have already incorporated InService EPC to manage service and parts information on their magnetic resonance imaging machines (MRI) MRIs and CT scanners.

Although the challenges of medical equipment maintenance and repair may appear daunting, guidance from the FDA, the medical device community and software developers like Enigma will help to smooth the regulatory transition, enabling medical equipment managers and technicians to maintain and service the machines that deliver the diagnostic care and treatment we all need.

If you’re a manufacturing company with over 500 employees, you’re not the middle. If you’re a single man shop with local customers only, you’re probably not the middle either. But if you’re somewhere in between, then you’re one of many that makeup the supply chain backbone that feeds the large OEMs. Collectively you represent more than twice the global employment of big name manufacturers. This bulging mid-section of the manufacturing world is what has been dubbed the missing middle.

“Being in the middle”, as the phrase suggests, comes with its own set of unique challenges and pressures.  There is a gap between what is expected from this group of manufacturers and what they’re capable of delivering. They’ve become overlooked and under-resourced.

The Manufacturing Institute website says, “The United States funds and conducts extensive basic research and possesses the manufacturing base to commercialize products, but lacks the development, engineering, and prototyping assets that enables ideas to move from mind to market.”  

Changing R&D Responsibility – pushing innovation downward

Big manufacturers used to lead innovation. They were idea generators, research and developers (R&D) and leaders of change. In the early 1980’s big companies contributed vast amounts to R&D investments. Today, their contribution appears paltry by comparison.  “In the past 30 years, R&D investment in the larger companies has plummeted — from 72 percent of total in 1981 to 40 percent in 2007” cites Jon Riley & Matt Sakey of National Center for Manufacturing Sciences (NCMS) in a joint report by Digital Manufacturing Report and NCMS.

So where did innovation go?  The middle.

More and more mid-size manufacturers have taken on the responsibility that big OEMs used to own. “Developmentally, 60 percent of R&D investment comes from the missing middle — up more than 40 percent since 1983” say Riley and Sakey. That’s a huge shift of time, resources and investment, and one that only the most fiscally sound manufacturers are poised to support.  As many mid-size manufacturers are struggling with their new ‘innovation’ job description, they’re still contending with other more day-to-day economic pressures in order to survive.

Economic Challenges – first to get hit, last to recover

The missing middle of manufacturing is getting uncomfortably squeezed from all sides. Over and above shifting innovation responsibilities, a faltering economy has added even more pressure.

“Small to midsize manufacturers are often hurt early during economic downturn because they tend to have limited resilience: limited cash reserves and access to credit, few customers, and limited product portfolios and inventory. For the same reasons, small to midsize manufacturers also take longer to recover” says Joe Barkai, Analyst and Practice Director for Product Lifecycle Strategies for IDC Manufacturing Insights.

Is Technology the Answer?

Technology shines like a bright spot in a dismal sky. It can help midsize manufacturers find sure footing in an otherwise rocky middle landscape.  NCMS’s Riley and Sakey believe that digital manufacturing – a computer based system of integrated manufacturing, modeling & simulation is the path to success.  “Those companies that do not leverage this technology [digital manufacturing] will take longer to design more at greater cost and with less guarantee of success.”  From Enigma’s perspective, we agree but on a much broader scale. Any integration of technology that improves an OEM’s manufacture, service and support leads to healthy competitive advantage.

As a software developer of an electronic parts catalog (EPC), Enigma has seen the impact first-hand, of technology on our own ‘middle’ OEM customers. As the demands of midsize manufacturing become more stringent, the power of software to maximize operational efficiency as well as aftermarket parts, service and repair becomes a fundamental imperative. InService EPC is a textbook case of how midsize OEMs can leverage their existing product, parts and service information to improve aftermarket efficiency and profits.

Enigma InService EPC has proven itself across industries. We’ve helped construction equipment manufacturers like DitchWitch and Bobcat as well as medical equipment manufacturers Toshiba America Medical Systems and public transportation like Dallas Area Rapid Transit (DART) leverage their parts and service content and integrate with in-house business systems to reduce cost and improve customer support.

We believe InService EPC is the best first step for the “missing middle” to apply technology because it uses information that already exists to enhance the most profitable part of a company’s business—the aftermarket.  By extracting new value from existing resources, the missing middle will make room for more innovation and accelerate response to ongoing customer demands.