Author: Bill Peatman, CIRTEC Medical Systems
When it comes to medical device manufacturing, two things are paramount: efficiency and quality. Efficiency is critical as device makers are racing to bring to new products to market as quickly as possible. Quality is critical because no medical device can be marketed that is not fully compliant and approved by the FDA as safe and effective. This is especially true for complex Class III medical devices, which face some of the most stringent quality requirements in the industry.
One overlooked aspect of medical device manufacturing is manufacturing facility design. Facility design can play an important role in advancing both efficiency and quality in the device development process. With manufacturers increasingly looking to outsource some or all of medical device development, the facilities of outsourcing partners can give them a competitive advantage when designed to maximize efficiency and quality.
Design and efficiency of work cells
One of the most important aspects of the medical device manufacturing process is the design and efficiency of work cells. Work cells are where device assembly happens, and critical to their effectiveness is the layout—“U” and “O” shapes being among the most common -- the clarity of instructions, and the positioning of tools and materials. Layout impacts the amount of travel required by technicians to gather materials and perform assembly tasks but perhaps most importantly, promotes cross training and work sharing.
Proper material identification and placement improves worker efficiency and product consistency by reducing time and eliminating mistakes in processing. Leading contract manufacturing organizations are constantly working to reduce assembly times by improved workplace organization and efficient work cell design. Former Toyota chief engineer Taichi Ohno, widely acknowledged as the founder of LEAN manufacturing, identified “excess travel” as one of the chief wastes of productivity in manufacturing.
For maximum efficiency, visual work standards should be deployed. These include standardized process times, the sequence of steps or process flow that is to be followed, controlled instructions used to complete each step, a study of proper inventory levels for the work area, and easy access to all materials and tools. All of these topics should be addressed so they are seen and understood at each station in the work cell.
In LEAN manufacturing, constant feedback is reported throughout the organizational structure by collecting, reporting and displaying of key performance indicators. Once standards are in place, continuous improvement programs can be implemented to reduce variation in a never-ending cycle of Define, Measure, Analyze, Improve and Control (DMAIC).
Medical device manufacturing processes may require an array of specialized equipment like lasers for welding or marking, and environmentally controlled systems such as glove boxes and bio/particulate control. Access to this equipment and technology is critical.
Equipment can be stationed in the work cell when the workload is justifiable but often equipment of this magnitude is shared among multiple work cells or involve other scheduling constraints such a preventative maintenance or process development and improvements. Facility design should integrate the use of these machines into the top level manufacturing process flow to improve efficiency.
The overall layout of a manufacturing facility can ultimately impact how efficient that facility can become. Interdepartmental interactions are promoted by proximity and functional adjacencies help to remove obstacles to the natural flow of work and information.
The position of formal and informal meeting places can facilitate collaboration and speed meetings by making it possible to meet or “touch down” near the assembly area and get right back to action. Also, conference rooms and visitor office space can make it easier for manufacturing partners and customers to review processes and meet with manufacturing personnel.
FDA's Quality System Good Management Practices
Medical device manufacturing facilities fall under the requirements of ISO 13485 and the FDA’s Quality System Good Management Practices, specifically US Code of Federal Regulations (CFR) Title 21, Part 820 Quality System Regulations (QSR). These requirements outline the criteria for successful quality programs for medical device manufacturers, and all facilities, equipment and processes must comply with these standards.
In addition, manufacturing facilities must adhere to ISO
14644 and/or FED STD 209E cleanroom requirements when relevant for the devices being manufactured. While a Class 7 or higher clean room is, for the most part, standard for Class III medical device manufacturing, cleanroom design and location can have a significant impact on both efficiency and quality.
One important consideration is to isolate the handling of materials such as platinum cure silicone—a common element in active implantable devices and one that is prone to contamination from other materials. Also, the transfer of materials into a cleanroom can be streamlined by integrating cleaning facilities into the workflow between them.
QSR Title 21, CFR Part 820 states repeatedly that firms must “establish and maintain” procedures for all aspects of device development. To do so, companies should define, document (either on paper or electronically), and implement standard operating procedures (SOPs). Additionally, companies must then follow up, review, and revise these documents as needed.
The intent here is simple: Companies must ensure that their organization develops and manages operationally sound procedures that are compliant with regulations and that result in safe and effective devices that perform as designed. Manufacturers should have a procedure development plan that is refined over time through quality system feedback loops including internal audit programs, corrective and preventive actions, and management review and employee feedback.
Quality requirements that apply specifically to the manufacturing facility design include device handling, acceptance procedures, procedures for dealing with non-conforming products, packaging, sterilization and marking. Facility design is particularly important in the handling of medical devices. Their movement through the building can often be the source of later defects through damage to the device or components or by becoming contaminated by exposure to the wrong environmental conditions.
Good medical device manufacturing facility design can improve efficiency and enhance quality, speeding the overall medical device development process. CIRTEC Medical Systems, a leading medical device contract manufacturer, has developed a “center of excellence for manufacturing complex implantable medical devices,” according to a news release. The ISO 9001 and ISO 13485 compliant facility features state-of-the-art work cells optimized for LEAN production processes, an integrated ISO Class 7 clean room, controlled environment assembly space, machine shop, and advanced engineering and metallurgical labs.
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. CIRTEC is ISO 13485 certified.