Scale-up studies and equivalency testing will be necessary to ensure consistent product performance as the CMO ramps up the manufacturing volume. (Credit: Web Industries Inc.)

For medical device developers and original equipment manufacturers (OEMs), the transition from prototype to commercial-scale production with a contract manufacturing organization (CMO) shouldn’t feel like a leap of faith across a giant chasm. The technology transfer phase, in particular, can mean different things to different people. By better understanding technology transfer’s purpose and priorities, device designers and their CMO partners can embark on this important stage more unified in their shared goals. This article offers a roadmap for what to expect during the tech transfer phase of the medical device product life cycle.

Tech Transfer’s Place in the Product Life Cycle

What is technology transfer and where does it fit within the product life cycle? It’s the life cycle stage nestled between project planning and commercial production (see Figure 1). During tech transfer, the CMO determines how to best manufacture a product on the developer/OEM’s behalf — economically and at high volumes. Not to be confused with product development, technology transfer is focused on manufacturing process development. Whereas product development prioritizes usability and performance, process development prioritizes manufacturability. Tech transfer’s objective is to produce a quality product consistently and cost-effectively, while achieving all of the designer/OEM’s physical and performance requirements for the device.

Device designers, developers, and OEMs can enter into a relationship with a CMO at many different stages in the product life cycle. In an ideal case, the CMO is involved early in the product development process to help with material specification and to consult regarding manufacturability risks and opportunities.

Fig 1. Medical device designers can enter into a relationship with a CMO at many different stages in the product life cycle.

To meet performance and economic objectives, tech transfer often requires the CMO to conceive an entirely different manufacturing process for a device — one that is highly scalable, fast, and efficient. Chances are, the way one device or hundreds of devices are made on the R&D bench or pilot line will need to be transformed, perhaps multiples times, to produce the thousands or millions of devices needed for commercial rollout. During this phase it is possible the CMO will make recommendations in device design for manufacturability.

In many cases, a device designer or startup has produced prototypes or small lots of devices and now needs to meet a much greater demand. The CMO works with the device developer to understand everything there is to know about how the device functions, how it is used, and how it has been manufactured to date, and then creates a plan for how to produce it at commercial-scale quantities.

At the end of the day, technology transfer is when a device’s design, materials and performance all must be dissected, analyzed, and viewed afresh to make the transition to mass-scale manufacturing.

Steps in Technology Transfer

CMOs often lead technology transfer through a structured stage-gate process. With this process in place, all key players should have clear visibility and understanding of how the project is progressing. If at any point risks or issues arise, such as quality control hurdles or information gaps, they must be addressed before moving toward the next gate. Transparency, enabled by frequent communication and collaboration between partners, is crucial. This helps ensure continued focus on the project mission and its objectives. For example, a CMO like Web Industries might hold weekly internal meetings to discuss a project’s progress and host biweekly updates with the device developer/OEM to debrief the customer. Here are some key steps in a tech transfer stage-gate process:

Documentation. During tech transfer, the device developer, designer, or OEM will share documentation about the product and how it has been produced to date. For example, a development house begins working with a CMO to scale up production of a lateral flow immunoassay (LFI) device. The documentation stage might include discussion and review of biochemistry, deposition, lamination, assembly, pouching, quality control test methods, packaging, raw materials, and supply chain management.

Raw Material Assessment. Raw materials are a huge factor throughout the entire device life cycle, but during tech transfer, they are truly put to the test. Ideally, most potential raw material issues will be discovered during the project definition and planning stage, when the CMO assesses material availability, quality, and specifications. As part of this initial design transfer review, the CMO might find that one of the specified materials is not readily available in large quantities or supplied in widths, lengths, or core sizes optimized for the CMO’s high-speed production equipment. Such findings would raise a red flag, posing a risk to project success that needs to be addressed. For instance, the CMO may be able to identify another material that matches the specifications and is feasible to procure in the necessary quantities.

During technology transfer, a contract manufacturing organization performs a variety of studies to ensure devices meet OEM performance requirements. (Credit: Web Industries Inc.)

Often, device prototypes are made through manual processes with materials supplied on sample cards, sheets, or small sample rolls. The tension, pressure, friction, and temperatures of a manual, low-volume production process can be quite different from those needed to support a large continuous reel-to-reel web production line.

Process Verification and Validation

The technology transfer phase is a time for the CMO to prove precisely how it is going to produce a device. First, there will be feasibility studies to determine whether the CMO’s existing equipment is capable of handling the materials and performing the processes to produce the customer’s product. Then through process characterization and process development, the CMO will determine what methods, machinery, and tools to use to make the device to the customer’s requirements, including initial equipment settings. Then there will be engineering studies to determine exactly how to calibrate equipment to get the desired results.

Scale-up studies and equivalency testing will be necessary to ensure consistent product performance as the CMO ramps up the manufacturing volume. To transition from 50 or 500 units to 50,000 units or eventually 5 million units, the CMO must test devices at frequent milestones along the way to ensure that the device’s physical properties and performance meet design requirements. For example, in scaling up production of an LFI device, the CMO must evaluate whether the test solution still performs as it should when made in incrementally larger batches. The LFI device from a batch of 50,000 devices must perform in precisely the same way as a device from a batch of 50 devices, i.e., negative and positive readings must appear in the same way as they do on the reference device or per the OEM’s specifications.

Conclusion

During OEM-CMO technology transfer, a prototype design does not enter one end of a “black box” and start coming out the other end at great quantities and speeds. Instead, tech transfer should entail a transparent, methodical, stage-gate process, with frequent communication between partners from day one until commercial-scale product delivery.

It is important to remember that tech transfer is not product development. Rather, during this important phase of the product life cycle, the CMO engages in process development to devise a way to make the device owner’s product efficiently and in large volumes. When business partners are aligned on tech transfer’s purpose, priorities and protocols, they can work together to successfully take medical device innovations from the bench to the big time.

This article was written by Claudio Hanna (This email address is being protected from spambots. You need JavaScript enabled to view it.), Business Development Director, and Miranda Conary (This email address is being protected from spambots. You need JavaScript enabled to view it.), Product Specialist, Web Industries Inc., Marlborough, MA. For more information, visit here .


Medical Manufacturing and Machining Magazine

This article first appeared in the March, 2019 issue of Medical Manufacturing and Machining Magazine.

Read more articles from this issue here.

Read more articles from the archives here.