Facing multiple challenges including cost pressure, global competition, and evolving market de mands, medical device companies may consider engaging with a design and manufacturing services company to achieve important goals. The right manufacturing partner can provide a range of services, from design and engineering through distribution, helping the device company accelerate time to market, control costs, and push multiple products through the pipeline simultaneously—even with limited internal resources. However, the keys to success are careful selection of the manufacturing partner, a detailed plan for the collaboration process, and an understanding of specific benefits that a manufacturing partner can deliver— and how to maximize them.
Performing Due Diligence
Once the decision is made to use a design and manufacturing services company, the all-important selection process begins. In an era of tighter regulations and heightened concerns about patient safety, a device company needs complete confidence in the ability of its manufacturing partner to meet the highest levels of quality, control, and compliance. This issue becomes even more complex when considering all the differences in requirements for various device types and across different regions, each with local regulations. (See Figure 1)
Equally crucial are the manufacturing partner’s technical and business capabilities, ranging from specialized design, testing, and manufacturing services to a robust supply chain and a proven financial track record. Therefore, a device company needs to perform a type of due diligence on manufacturing partner candidates, focusing on their regulatory expertise and compliance as well as their healthcare experience, technology expertise, and business processes.
In the area of regulatory, following are some important questions: Does the manufacturing partner know the riskbased classification system that determines a medical device’s regulatory pathway? Each of the device classes in the US, European, and Canadian systems carries a different set of requirements, particularly the stringency of controls, with which the manufacturing partner needs to be familiar.
Does the manufacturing partner know the Food and Drug Administration’s Quality Systems Regulation? Because the quality systems regulation is simply a guideline, the manufacturing partner must be able to use it to create an effective manufacturing process that meets regulatory requirements and produces a safe and effective device.
Has the manufacturing partner received ISO 13485 certification demonstrating its conformance with quality management system standards? Certification is critical for a manufacturing partner because it can help accelerate the product approval process.
Does the manufacturing partner understand the design controls incorporated into the design and development process? The use of design controls increases the likelihood that discrepancies can be corrected earlier in the development process, avoiding costly rework and delays.
Does the manufacturing partner have experience with devices targeting multiple medical markets? A global manufacturing partner can serve as a consultant to a smaller or regionally focused device company, saving time and avoiding mistakes or omissions.
Does the manufacturing Partner maintain internal documentation programs that integrate with the device company’s system? Improper documentation is considered the numberone risk factor in any medical product transfer from third party to medical device company.
Next, device companies should pay close attention to the manufacturing partner’s ability to service the medical device sector. Although manufacturing partners traditionally offered high-volume production of consumer electronics, some are diversifying their services to include design and development, testing, assembly, packaging, logistics, order fulfillment, and other aftermarket services. Some manufacturing partners have built or upgraded clean rooms, centers of excellence, and other specialized facilities; undergone certification to the ISO 13485 standard; and assimilated current Good Manufacturing Practices.
At the same time, a manufacturing partner’s expertise in electronics can be very valuable to device companies as devices become smaller, more complex, and more dependent on software and wireless networks. Technology transfer from consumer electronics, with its relentless drive toward miniaturization, for example, spares device companies the risk and expense of investing in these new breakthroughs. (See Figure 2)
Companies planning to market their devices in specific regions or countries should seek manufacturing partners offering global reach paired with local presence. Knowledge of the local area and its regulations, already built and scalable manufacturing infrastructure, and a network of established suppliers enable fast in-country turnarounds of new projects. Large manufacturing partners also offer business continuity through their ability to transfer a project to a sister facility and to tap alternate suppliers.
Structuring the Collaboration
Large manufacturing partners typically have a global footprint with engineering and manufacturing locations spread all over the globe. This makes it easy to support and interface with the device company, not only at its headquarters in the US, Europe, or another location, but also at offshore sites. This geographical proximity fosters close collaboration and gives the company a greater level of control.
Recently, many medical device companies have begun to establish design and new product introduction sites in China. The local presence of many large manufacturing partner organizations in China allows a high degree of customer oversight and also boosts efficiency.
The typical method for collaboration between the manufacturing partner and the device maker is a regular schedule of joint project meetings, business reviews, and technical meetings. In many cases, it makes sense to place engineers from the manufacturing partner company on site at the device company’s premises for a couple of weeks to kick off the project and set up a good relationship. Once the engineers become familiar with the product and the device company’s requirements and both teams are well acquainted, working remotely is a much easier job.
In some cases—such as when there are multiple products and/or process changes or when a project requires intensive and immediate communications— manufacturing partners have found it appropriate to embed a small team of engineers at the device manufacturer’s premises on an ongoing basis. This may also be arranged to facilitate the transfer of a product to the manufacturing partner organization.
In addition to integrating teams through face-to-face collaboration, it has become common practice to work in a virtual environment. Technologies including web conferencing, video conferencing, data rooms and online authorization tools are increasingly important for enabling device manufacturers to retain control when utilizing a manufacturing partner.