Author: Bill Peatman, CIRTEC Medical Systems 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 units 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. pic-1 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. What’s different about these devices? Many Class III implantable devices are small enough to be implanted through a vascular catheter, meaning they are small enough to be deployed through a human blood vessel. They can also require advanced sealing technology to protect the device from fluids in the body, and wireless power transfer through the skin. Manufacturing these devices requires expertise in material science, power management, microelectronics, hermetic sealing and testing, and more. pic-4Handing 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 involves qualifying just 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.

Experience

The first consideration is experience. Has the manufacturer successfully delivered the type of device being developed? The requirements for Class III implantable devices are very different from the requirements for Class I disposable medical devices, most notably including the FDA’s premarket notification and premarket approval, adding two additional layers of requirements. It is also important that the manufacturing team have the expertise in the materials, electronics, power supply and hermetic sealing technology needed to make successful device. Hermeticity requirements differ with device size, architecture, materials, and planned device lifetime. 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.

Quality

It is also critical to look at is the organization’s quality system. Quality should be more than a department in a medical device manufacturer. It should be an obsession. It can be argued that there is nothing more important to medical device manufacturing than quality. A strong quality system starts at the earliest design stage and continues throughout the life of the product and even after it. Every employee should understand his or her role in a manufacturer’s quality system. All three stages of production, from an early prototyping feasibility design control phase, to a clinical/pilot manufacturing phase, to a commercial manufacturing phase, should involve stakeholder visibility into the records and documents of the entire process.

Flexibility

pic-5A medical device manufacturer needs to be flexible enough to account for rapid iterations during the prototyping phase while also having robust production and quality system controls for pilot manufacturing in support of design verification and clinical trials. The contract manufacturer should also have sustained manufacturing systems in place including inventory and supplier management procedures, the ability to track post-market defects and corrective actions, and support for lean manufacturing initiatives. Once a prototyping is deemed complete and the product moves into the pilot/trial phase, there should be few if any changes between pilot and production.

Infrastructure

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. There is a secondary benefit to having prototypes built using the same equipment that will be used for manufacturing. Creating a prototype on a lab bench or hand tools may not perform identically to a device made with machinery and automated processes; consistency in the manufacturing infrastructure is much more likely to result in equivalency between prototype, pilot, and production devices. This can be a significant benefit of outsourcing the entire device manufacturing process to a single partner—to make sure the same people, processes and equipment are used from initial design through commercialization. pic-6Remember 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 provides design, development and manufacturing support to the medical-device industry with a particular focus on active implantable devices and peripherals as well as minimally invasive systems. It supports the full product development cycle, from requirements definition through commercial manufacturing. It will soon open a new 35,000-sq-ft 'Centre of Excellence' for implantable medical device development, with a 5,000-sq-ft clean room and a 6,000-sq-ft controlled environment assembly space, on site machine shop and laboratory. CIRTEC is ISO 13485 certified.