Medical device manufacturing can be roughly divided into three phases: prototype, pilot and production. A prototype is typically a working model of a design that demonstrates a device’s appearance and functionality. The pilot product is the version of the device used in clinical trials to prove a device’s safety and effectiveness, and to win clearance from regulators. Production products are the final version of the device that is sent to market. In most cases there should be little difference between pilot and production products other than the volume in which they are produced.
In the race to bring new products to market as quickly as possible, it is increasingly common for medical device developers to outsource all or part of the manufacturing process to experts in specific areas of medical technology. This is especially true in the world of complex Class III implantable devices, one of the most highly regulated production processes in the world.
Handing off prototyping, pilot and volume production to a single firm can save precious time and money in the development process, as design and knowledge transfers can be streamlined, and the risks involved in using different manufacturing equipment, tools and personnel can be eliminated. Also, using a single source for prototyping to production creates means only qualifying a single supplier, and creates a single source of accountability for the entire manufacturing process, further simplifying communication.
That said, there are a few things to consider when selecting a manufacturing partner for a complex implantable medical device.
The first consideration is experience. Has the manufacturer successfully delivered the type of device being developed? The requirements for implantable devices, for example, may be very different from disposable medical devices. It is important to know that qualified and experienced people, facilities, equipment and processes are in place to streamline all aspects of device development and production for the type of device being made.
It is also important to look at is the organization’s quality system. The quality system should include both design and manufacturing quality monitoring and control systems. A strong design control system will be structured to support all three stages of production, from the early feasibility design control phase for prototyping, a clinical/pilot manufacturing phase, and a commercial manufacturing phase.
A medical device manufacturers quality system should also be flexible enough to account for rapid iterations during the prototyping phase. The includes the ability to document all design and material changes as the prototypes evolve during prototyping, with controlled device builds, and sustained supplier management that can adapt from prototype to pilot to and production, including the ability to track defects and corrective actions and other post market issues critical to the production process.
Significant efficiencies can be gained by using the same manufacturing infrastructure for the entire production process. Prototyping done using production equipment can greatly accelerate time to market by eliminating the need to redevelop processes, reprogram equipment, or retrain personnel. This assumes that the contract manufacturer has the right human and technical resources to support each production phase – R&D engineers with experience in prototyping, process development engineers to support pilot manufacturing, and manufacturing engineers to set up manufacturing cells and execute process improvements during commercial manufacturing.
Remember that in medical device regulatory submissions, the processes, materials and equipment that will be used in volume production are also “on trial” as part of what regulators look at when considering device approval. A medical device not only has to function as specified; the manufacturer must also demonstrate how the design, design controls, manufacturing processes and equipment all ensure consistent device performance and patient outcomes. A manufacturing partner must be equipped and experienced with all the required documentation and reporting procedures.
CIRTEC Medical Systems has decades of experience bringing complex implantable medical devices to market, with expert scientists, engineers, and technicians that have been helping device developers solve problems and overcome challenges in all phases of manufacturing. CIRTEC will soon open a new 35,000-square-foot “Center of Excellence” for implantable medical device development, with a 5,000-square-foot clean room and a 6,000-square-foot controlled environment assembly space, on site machine shop and laboratory, all designed to enhance manufacturing quality and efficiency.