Medical device and pharmaceutical manufacturing companies are increasingly outsourcing their manufacturing activities. Designing, developing and engineering a new product is demanding and competitive, and companies are turning to contractmanufacturing organisations (CMOs) to help them gain an edge in the marketplace. With the advent of technologies such as 3D printing, the industry landscape is changing, and what was once just a vision for a pioneering new device can now become reality with the help of a contract manufacturer.

This shift has produced opportunities for contract manufacturers to become an extension or manufacturing arm of these companies; with a shortage of talent at original equipment manufacturers (OEMs), growing consolidation, and combination products such as drug delivery devices and smart devices, CMOs are increasingly in demand. Tapping into the design expertise of a contract manufacturer helps OEMs position their product for success. Early collaboration from the initial design concept phase allows the OEM to help anticipate any potential problems that can occur during pilot production, clinical trials and the resulting highvolume manufacturing.

The right fit

Choosing a CMO is an important decision. Not only does the company need to be able to create the products the customer wants at the highest quality, it needs to be flexible in its approach. The contract manufacturer might be working with a small start-up company or a large multinational corporation, catering for a labour-intensive but low-volume project, like a clinical trial, or a highly automated, high-volume assignment – and it must have the capacity and resources to deal with whatever task is thrown its way.

What an OEM or medical device company needs and wants should not be restricted by the limitations of the contract manufacturer; the latter must develop and produce solutions to satisfy its customers’ specific requirements. The CMO must have a dedicated, flexible team offering consistent service and robust quality assurance systems that will work with the customers’ expectations. In order to do this, the contract manufacturer must have the capacity to explore and invest in new technologies as they become available.

OEMs can have a wide range of products across many markets, sometimes including the drug and device being packaged together. Ideally, a CMO should be able to support each of these product ranges. To ensure this happens, the contract manufacturer should have a broad knowledge and a variety of tools at its disposal; operations might include powder or liquid filling, drug encapsulation, injection moulding and blister-packaging services, for example. These diverse offerings would allow a CMO to augment its relationship with the OEM and offer added value to its customer.

Bill Welch, chief technology officer at Phillips-Medisize, says there are a variety of reasons to use a CMO, including R&D, intellectual property, regulations, marketing and sales. According to Welch, companies can leverage the greater scale and lower cost of a CMO, taking advantage of its infrastructure, and allowing more capital to be channelled into core competencies such as R&D and product development. They can also gain access to technical manufacturing capabilities that are costly or timeconsuming to create internally.

“The CMO that can best execute during product development and industrialisation finds itself at a competitive advantage,” he says. “When product launch success depends upon speed to market, medical device OEMs and their CMO partners benefit by joining forces. Such partnerships can free medical device companies to focus on their core competencies, while leveraging their CMO’s existing, proven, regulatory- compliant manufacturing processes and infrastructure. Furthermore, early collaboration from the initial design concept phase allows the CMO to help anticipate potentially problematic areas that can occur during pilot production, clinical trials and eventual high-volume manufacturing.”

The decision to partner with a CMO is a critical one, and a rigorous selection process, that emphasises fit with the company strategy and needs, reduces the risk of downside.

High priorities

Quality is of the utmost importance: recalls and market delays can be costly to OEMs financially and in terms of reputation. Even the smallest errors can derail a successful product development effort, resulting in lost time and resources, and missing key deadlines. This could cause the product development or regulatory submission to conclude before it has really started. This is why many OEMs are turning to CMOs earlier in the design and development stages, to ensure quality is built into the design. OEMs will look for contract manufacturers with infrastructure to support their development needs, including test labs, cleanrooms and equipment for prototype or clinical builds, and a development process focused on healthcare products. Those with quality systems that match the OEM’s programme needs, such as design controls, an active internal auditing programme, and an established corrective and preventative system, will also stand out. The CMOs might also be expected to monitor ongoing quality and provide trend analysis or offer complete document support to their customer.

Perhaps most importantly, the CMO should have a global reach – access to multiple markets that will allow a medical device company to increase its presence around the world. A contract manufacturer with a global presence could have the knowledge and experience that a customer might not have; for example, it might be able to reduce the impact of language barriers and time zones, as well as offer guidance in traversing the different licence and regulation requirements in foreign countries. A strong integration with the intended manufacturing location to match design, process and manufacturing capabilities, should start at concept development.

“Leveraging a CMO’s global footprint can also assist in entering new markets,” Welch explains. “For example, using a CMO in China that is CFDA-registered and… that can offer product registration services, will provide a much faster and less expensive way to access the Chinese market. Not only would the manufacturing infrastructure costs be lower by using the CMO footprint, the existing talent and quality-management system (QMS) can take years to develop if starting from a blank slate.”

As well as offering development and manufacturing expertise in the OEM’s market segment and product type, Welch says a contract manufacturing company must have the flexibility to meet an OEM’s geographical need for product development services and manufacturing locations. It should have an understanding of the local service and regulatory needs, along with global quality and manufacturing standards. Contract manufacturers must adhere to the industry’s quality management systems and be adaptable to global requirements. They must also be able to trace and document products.

A vital point to consider is the contract manufacturer’s point of contact, particularly if work is to take place in a foreign location. The CMO should have a programme-management function to serve as a single point of contact and guide the OEM through the product development phases, from concept development to industrialisation. There must be a flow of communication between the customer and its contract manufacturer to help manage expectations and resolve any issues if they should arise.

“We partner closely with our customers to make their innovative designs come to market with the highest regard for safety, scalability, and protecting their intellectual property and designs,” says Welch. “We believe that the integrity of our people and processes helps bring our clients’ innovation, ideas and products to market. To ensure that, we have developed a demonstrated ability to integrate advanced moulding, scalable assembly, and quality control systems into the product design and manufacturing process, to deliver innovative, high-quality, cost-effective solutions for them.”

He continues, “Strong partner management and governance also supports communication in multiple forums, typically a joint steering committee for programmes in development and new product introduction; a quarterly business review for programmes in production; and executive governance to support the working teams, ensure organisational alignment and address minor pain points before there is a significant impact on the overall relationship.”

Should the worst happen, the CMO should have a contingency plan to ensure continuity of supply, whether that involves switching production to another plant with the same equipment or solving the problem as quickly as possible. Continuity of supply is critical for any OEM and should be given thought when selecting a contractmanufacturing partner – unexpected delays can be costly.

Even the smallest errors can derail a successful product development effort, resulting in lost time and resources, and missing key deadlines.

Critical choice

But there are some negatives to hiring a contract manufacturing company, especially if it turns out to be the wrong one. “The decision to partner with a CMO is a critical one, and a rigorous selection process that emphasises fit with the company strategy and needs reduces the risk of downside,” says Welch. “Strong CMO partner management and governance processes also serve as a basis for successful longterm CMO relationships.”

Welch believes partnerships that facilitate a smooth flow through each stage have a distinct advantage, not only for speed and reduced cost, but also for reduced risk once the product reaches the market.

“On the other hand, a disjointed approach can marginalise development and introduce risk,” he adds. “A common hazard that jeopardises programmes is the isolation of strategic design decisions. For example, if manufacturing development is abruptly introduced at the end of the design phase, there is a possibility that changes may threaten stakeholder requirements and the programme.”

For an OEM, choosing a contractmanufacturing company to help in the design, development and industrialisation of a new medical device or pharmaceutical product can be an incredibly important decision. It is essential that such partnerships are built on mutual understanding – especially when medical or diagnostic device development and intellectual property are in question. Choosing the right contract manufacturer can result in successful long-term relationships: the manufacturer that fits best with the OEM can offer an innovative partnership that considers the entire opportunity life cycle with a global reach and expertise. It can ensure quality is built into the product.