7 reasons for the medical device outsourcing trend: “Yellow line” becomes mainstream
Learn how a facilities management partnership can improve the quality of your facilities operations and allow your organization to focus on what matters most.
As medical device innovation evolves, so does the industry’s outlook on outsourcing. Medical device companies have typically outsourced specific functions, including clinical trials and manufacturing, to reduce costs and improve efficiency. Outsourcing facilities management (FM) has been less common because it was once considered too risky for highly sensitive medical device research and development (R&D) or production facilities. Now, the medical device industry is becoming more open to new ideas for managing real estate, facilities, and the processes that take place in them.
This openness to real estate and facilities partnerships drive medical device companies to be more agile. It also alleviates the pressure to deliver products into the marketplace quickly and within the bounds of regulatory compliance. A qualified FM service provider can not only keep your facilities running smoothly, but also can manage virtually every aspect of the environment in which your products are manufactured and prepared for market. Ideally, outsourced FM frees your team to focus on the core business of your medical device enterprise, confident that the facilities team is taking care of the facility details.
Concerns about specialized GxMP “behind the yellow line” facilities expertise has been one factor preventing the medical device sector from embracing outsourced FM as many other industries have. Contrary to popular perception, it’s possible to find an FM partner with deep knowledge of medical device facilities and GxMP. The right partner will offer industry-specific, best-in-class practices that minimize cost and risk while maximizing efficiency, reliability and, most important, safety.
Putting the ‘clean’ in cleanroom
Few environments are as subject to quality and safety oversight as medical device manufacturing, particularly with regard to cleanrooms. The right FM partner will rigorously maintain your cleanrooms—and the associated gowning rooms and packaging operations—to meet ISO 5-8 requirements concerning easy-to-clean surfaces; controlled temperature and humidity levels; air quality monitoring; and maintaining aseptic conditions.
And, they’ll readily adapt to new requirements, such as those dictated by ISO 13485. They’ll have best practices for maintaining HEPA filters, for example, or eliminating electrostatic charges in the production environment.
Taking calibration standards to the next level
A seasoned, specialty FM partner will recognize that keeping building and production equipment properly calibrated is critical for medical device quality and safety. It will have in-house expertise and technology for maintaining calibration standards, and a laboratory for testing the accuracy of its calibration equipment.
Offloading calibration to an experienced FM partner removes the burden of a resource-intensive, yet essential, aspect of medical device manufacturing and packaging. A seasoned FM partner will not only perform the tedious, hands-on work of complex calibration tasks, but also will assume responsibility for documenting calibration activities, along with other FM processes that affect product quality. They’ll be equipped to maintain records of everything from the dates on which a device was calibrated and the findings of the calibration to the qualifications of the staff members performing the calibration. When a regulatory agency requests compliance reports, your FM provider should be able to quickly deliver essential records—and help you reduce the risk of costly product launch delays and recalls.
Reduce operating costs through proactive equipment maintenance
Electrical, heating, ventilation and cooling systems can malfunction at any time, triggering problems that can threaten a production line, or even shut down an entire facility. A qualified FM service provider will use preventive maintenance optimization (PMO), and predictive maintenance strategies, to maintain uptime and extend equipment life—reducing your operating costs.
PMO uses sensors and other devices to measure equipment vibration and other elements of equipment performance, revealing when a piece of equipment is behaving abnormally. One advantage of working with an FM partner is that its team will know how to use PMO methodology and technologies in your environment to optimize uptime and reduce maintenance costs.
By analyzing the data generated by the monitoring technologies, facility engineers can proactively address maintenance issues rather than following the traditional fixed calendar schedule of maintenance tasks. And, the cost of monitoring technology has fallen in recent years, enabling a strong return on investment in terms of reducing risk and improving uptime.
Reducing the hazards of hazardous waste management
From solvents and wastewater to unused products subject to U.S. Resource Conservation and Recovery Act requirements, hazardous waste is a fact of life for most medical device production facilities. Hazardous waste also can be a hidden source of safety and compliance risks, because not every medical device organization has the in-house expertise to manage it properly. Worse, your staff may be inadvertently exposed to chemicals that are harmful to human health.
An FM service provider with proven expertise will manage your hazardous waste responsibly and safely. Its team will ensure that waste is properly handled within regulatory time frames and with proper documentation, including using the right shipping codes for materials sent offsite for processing.
Improving the human experience in your workplaces
The benefits of FM outsourcing extend beyond the particulars of managing your offices and complex technical environments. An FM partner also can support your talent retention and recruitment goals by helping you provide a supportive, engaging workplace. It’s possible to find an FM service provider that not only understands the unique challenges of your technical facilities, but also can deliver human experience services that improve employee wellbeing, productivity and satisfaction. And, your partner can manage workplace amenities such as outdoor spaces, fitness centers, on-site dining options and more.
Retaining the familiar faces of your in-house FM team
Contrary to popular perception, outsourcing doesn’t mean the loss of the FM staff you already know and trust. Rather, your FM service provider typically will seek to hire your in-house facilities personnel so you can continue to benefit from their institutional knowledge of your facilities. A seasoned FM provider will have a proven approach to transitioning, onboarding and training employees so your facility operations don’t miss a beat.
By joining the FM service provider’s team, your trusted FM personnel will receive training in industry best practices and use of leading technologies for FM operations in medical device facilities. Those familiar faces will continue to be present at your facilities—but will be backed, ideally, by the FM service provider’s deep bench of expertise in medical device compliance, building engineering, building operations, energy management and more.
Working for “me” or “we”?
Aside from concerns about FM service providers’ ability to perform in a highly regulated environment, it’s natural to have concerns about costs vs. quality of service in FM outsourcing and partnership agreements.
The reality is that FM outsourcing doesn’t have to be all-or-nothing. You may choose to outsource certain facilities functions or want to adopt leading FM technologies, but lack the resources for the associated capital investments. A leading service provider (a true FM partner) will offer scalable FM options, such as energy and sustainability services; shared mobile engineering services; a digital marketplace for procuring services at negotiated volume-discount rates from vetted vendors; or a subscription-based mobile work-order platform that enables your FM team to seamlessly manage vendors and budgets on the fly, and to create audit trails.
Whatever the scope, service quality can be built into your FM service provider agreement. In fact, the most successful outsourcing relationships are designed as win-win “we” partnerships rather than as traditional vendor-service agreements. Instead of mandating specific tasks, such as replacing HEPA filters every week, a partnering contract can instead focus on desired outcomes, such as maintaining or exceeding air quality standards in your cleanrooms or R&D environments at least 99% of the time.
By focusing on outcomes rather than detailing the “how” of performing the work, an FM outsourcing contract frees you from the minutia and frees the outsourcing partner to bring creative solutions to your facilities challenges. Your FM partner will focus on achieving your business outcomes, rather than on completing a checklist.
A leading FM firm will seek to contractually align their fee structures with clearly stated and agreed-upon outcomes, including fees-at-risk for achieving or exceeding goals. They’ll want to establish key performance indicators at the beginning of the relationship to track their progress toward your business outcomes and hold their team accountable for achieving results.
At whatever level, an FM partnership offers the potential to improve the quality and performance of your facilities operations, and improve your compliance track record, too—while reducing your real estate and facilities costs. By entrusting a proven FM partner with management of your facilities, you can concentrate on what your organization does best: the design, manufacture, and delivery of safe devices that the public and patients can trust.