7 Factors Contributing To The Medical Device Outsourcing Trend: The "Yellow Line" Becomes More Widely Accepted

As medical device innovation progresses, so does the industry's perception of the value of outsourcing services. In order to cut fees and increase efficiency, medical device businesses have traditionally outsourced key services, such as clinical trials and manufacturing. Due to the perception that outsourcing facilities management (FM) for highly sensitive medical device research and development (R&D) or production facilities was too dangerous in the past, the practice has become less popular. It is now becoming more receptive to innovative ideas for managing real estate, facilities, and the activities that take place in those spaces as the medical device sector grows in maturity.

Medical device firms become more nimble as a result of this willingness to collaborate on real estate and facility collaborations. It also alleviates the strain to get items into the marketplace as rapidly as possible while remaining within the confines of regulatory compliance requirements. The expertise of a trained facility management service provider can not only ensure that your facilities work effectively, but they can also manage nearly every element of the environment in which your products are created and readied for sale. Idealistically, outsourced FM frees up your team's time to concentrate on the main business of your medical device organization, secure in the knowledge that the facilities team is looking after the minutiae.

Preoccupations with specific GxMP "below the yellow line" facilities knowledge have been one reason holding back the medical device industry's adoption of outsourcing facility management, as has been done by so many other sectors. Contrary to common confidence, it is feasible to locate an FM partner who has extensive understanding of medical device facilities as well as GxMP compliance requirements. In order to minimize expense and risk, the proper partner will provide best-in-class techniques that are particular to the business and that maximize productivity, dependability and, most importantly, safety.

Putting the 'clean' in cleanroom is an important step.

The manufacture of medical devices, particularly in cleanrooms, is one of the most stringently regulated settings in the world in terms of quality and safety. When you partner with the right facility management company, your cleanrooms—as well as the associated gowning rooms and packaging operations—will be rigorously maintained to meet ISO 5-8 requirements for easily cleanable surfaces, controlled temperature and humidity levels, air rate monitoring, and maintaining aseptic conditions.

Furthermore, they are easily adaptable to new criteria, such as those prescribed by ISO 13485, without difficulty. The best practices for maintaining HEPA filters, for example, or for minimizing electrostatic charges in the manufacturing environment will be available to them.

Taking calibration standards to a new degree of sophistication

Experienced speciality FM partners understand that maintaining the accuracy of building and production equipment is crucial to the quality and safety of medical device manufacturing processes. A calibration standards maintenance facility, as well as a laboratory for verifying the accuracy of its calibration equipment, will be available to it in-house.

Transferring calibration responsibilities to a seasoned field service partner alleviates the strain of a resource-intensive, yet critical, component of medical device manufacture and packaging. The arduous, hands-on work of difficult calibration tasks will be performed by a seasoned FM partner, who will also accept responsibility for documenting calibration operations and other FM procedures that have an impact on product quality. In addition, they'll be able to keep track of everything from the dates on which a device was calibrated and what was discovered during the calibration to the qualifications of those who performed the calibration. When a regulatory agency demands compliance reports, your facility management provider should be able to rapidly supply the documents that are required—and help you decrease the likelihood of costly product launch delays and recalls.

Reduce operational expenses by doing preventative maintenance on equipment.

Electrical, heating, ventilation, and air conditioning systems can fail at any time, resulting in difficulties that might jeopardize a manufacturing line or even cause the entire facility to shut down completely. Maintenance optimization (PMO) and predictive maintenance methods will be used by a certified FM service provider in order to maintain equipment uptime and prolong equipment life while simultaneously lowering your operational expenses.

PMO use sensors and other devices to detect equipment vibration and other aspects of equipment performance, allowing them to identify when a piece of equipment is acting in an irregular manner. As an added benefit of partnering with a facility management partner, its staff will be knowledgeable on how to use PMO methodologies and technologies inside your environment in order to maximize uptime and decrease maintenance costs.

Facility engineers can address maintenance concerns in a proactive manner rather than following the typical set calendar schedule of maintenance work by evaluating the data supplied by monitoring technology. Furthermore, the cost of monitoring technology has decreased in recent years, allowing for a significant return on investment in terms of risk reduction and uptime improvement.

Lowering the risks associated with hazardous waste handling

Hazardous waste is a reality of life for most medical device manufacturing plants, ranging from solvents and wastewater to leftover items subject to the provisions of the United States Resource Conservation and Recovery Act. Hazardous waste may also be a source of safety and compliance hazards that go unnoticed since not every medical device company has the in-house skills to effectively handle it. Even worse, your employees may be unintentionally exposed to substances that are dangerous to human health.

An FM service provider with established knowledge will manage your hazardous waste in an environmentally responsible and safe manner. Trash management will be overseen by a team of professionals who will ensure that waste is correctly handled within regulatory time periods and with sufficient documentation, including the use of appropriate shipping codes for goods shipped offsite for processing.

PRO-TECH Design & Manufacturing, Inc. provides customers with a comprehensive range of medical device outsourcing services, including package design, assembly, and contract sterilizing services, among other things.

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