As an ISO 13485:2012-certified, FDA-registered contract medical device manufacturer, Proven Process takes concepts to reality in our scalable, cGMP-compliant manufacturing facility. This facility features more than 20,000 square feet of manufacturing space, a Class 10,000 clean room, as well as model and prototype assembly labs. Oversight of supply chains is carefully managed for optimal costs, and the highest safeguards in documentation ensure lot control of raw materials. We have the talent and the resources to take your medical device manufacturing project from pilot to full-scale manufacturing with comprehensive and stringent project management oversight every step of the way.
cGMP cell based manufacturing efforts are managed with a flexible lean structure allowing for maximum efficiencies when building devices in small or larger volumes.
Proven Process's manufacturing facilities are compliant with Good Manufacturing Practices (cGMP) for medical devices. We believe that a system of checks and balances is a critical element in creating anything worth building.
For medical devices that are ultimately used to treat patients, quality is an imperative. To ensure your medical devices achieve FDA cGMP compliance, Proven Process has implemented a comprehensive quality management system covering design, manufacture, packaging, labeling, distribution, installation, and storage. Our quality assurance engineers and documentation experts work closely to ensure that all aspects of the manufacturing process are managed, adhered to and closely monitored.
Medical Device Manufacturing: A Primer
Medical device manufacturing is a growing industry. The global market for such devices was $413 billion in 2017, with the United States accounting for roughly 45 percent of sales. Medical device manufacturing is expected to grow approximately 5 percent annually, with sales reaching almost $530 billion in 2022. According to the most recent census, 356,000 people are employed in the industry by roughly 5,800 companies, 80 percent of employ 50 employees or fewer.
The term "medical device" covers several types of instruments. It includes implantable devices, some of which are active (e.g., pacemakers, drug delivery pumps, neurostimulators) and some of which are passive (e.g., access ports, catheters). Other devices are used externally in both clinical and in-home settings. Artificial heart pneumatic drivers, RF ablation consoles, and surgical robots are used within a therapeutic or surgical theater. Others are used for diagnosis and patient monitoring. In this group are disposable sterile kits, RF probes and generators, and wearable medical devices (wearables). In-home medical devices include portable blood pressure and diabetic monitoring devices. Devices that don’t interact directly with patients, such as cleaning and disinfection systems, are also included by definition.
Medical device manufacturing is ever changing and improving, with new technologies solving long-standing problems while new issues arise to be addressed. Several important trends are expected to influence the industry in 2018:
- From Volume to Value: Healthcare has long been based on the fee-for-service business model, but this has lead to spiraling costs. For the past several years, the medical industry has been moving to outcome-based reimbursement. This switch from relying on volume to relying on quality will impact medical device manufacturers as well. Focusing on device performance while controlling costs will become increasing important to medical device manufacturers this year and in the immediate years to follow.
- Cybersecurity: With medical devices becoming increasingly connected to hospital data networks and the Internet, they are becoming the targets of cyber attacks. The FDA has expressed concern for these risks, especially after vulnerabilities were identified in some devices — such as pacemakers — that would allow hackers to turn them off remotely. While cyber security has been a front burner issue for Medical device manufacturers, the need to be aware of and respond to these threats in all of their forms, and work to harden targets in advance of attacks, will continue to be a priority issue through the end of the decade and beyond.
- Unique Device Identification (UID): A federal law passed in 2007 addressed the need to provide unique identification for each device to allow for tracking. UIDs have been mandatory for Class II and III devices, a specialty of Proven Process Medical Devices, since 2016. Medical device manufacturers have also been required to implement UIDs for Class I devices since September 2017.
- Wearable Devices: The gap between implantable medical devices and medical devices separate and apart from the human body is increasingly being bridged by wearable devices that can monitor patient vital signs, physical and physiological activity, and other critical information. Real-time monitoring of patient information can lead to better treatment outcomes while identifying critical healthcare issues before they become life threatening. Medical device manufacturers will need to continue to innovate in this area, paying particular attention to the ways that machine-learning algorithms and artificial intelligence can improve device usefulness.
- 3D Printing: 3D technology has advanced considerably in the last few years. It is now at a stage where 3D printers can be used to quickly produce low-cost prototypes. Within the foreseeable future, 3D printers could reach a stage of quality, accuracy, and functionality where medical device manufacturers could use them to produce finished products, decreasing the time to progress from design to implementation while lowering costs.
The two primary stages in the production of medical devices are design and manufacturing. Proven Process Medical Devices can expertly handle one or both for any medical device initiative. In some cases, clients have already progresses through the design process and are requiring help with implementation. Other times, clients come to Proven Process for our considerable design ability for a medical device that they will manufacture themselves. In most instances, we handle the entire process from medical device design to medical device manufacturing, validation, testing, and packaging.
Specialized facilities are required for medical device manufacturing. In addition to a production area, medical labs are used for both the design and manufacturing phases. These on-site labs provide engineers with the opportunity to test new products quickly, allowing changes to be made rapidly to the design as needed. Given the need to manufacture medical devices that are free from contaminants, a cleanroom is often required. Cleanrooms provide a controlled environment that eliminates particulate and biological contaminants through the use of advanced filters, specialized clothing, and a hermetically sealed work area.
Conforming to International Standards
The medical device manufacturing process must conform to the strictest of standards. The international standard for medical device manufacturers is ISO 13485:2012, which sets standards regarding both product quality and compliance with governmental regulations. Companies earning this certification have consistently met both regulatory and customer requirements. Within the United States, regulations for medical devices are known as Current Good Manufacturing Practices (cGMP). Developed in the late 1970s and updated in 1998 following the passage of the Safe Medical Devices Act, cGMP requires medical device manufacturers to establish and adhere to quality control processes to ensure that their devices meet the appropriate standards and comply with applicable regulations. The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for certifying that medical devices meet appropriate standards before they are made available for patient use.
Pilot Medical Device Manufacturing
Pilot manufacturing and full-scale production are the two primary types of medical device manufacturing. Pilot manufacturing is the process of developing the manufacturing process for a particular medical device. Engineers iteratively work through the steps, making improvements that refine the process. This helps control costs and identify issues prior to commencing with full-scale production. This also enables the feasibility of the project to be assessed prior to any major investment in specialized equipment. Pilot medical device manufacturing can be carried out for designs created by Proven Process or by designs brought to us by our clients. Once the pilot manufacturing phase is completed and the process approved, full-scale production of the device can begin.
The medical device manufacturing process begins with the materials supply chain, which must be monitored and documented both to assure the quality of the raw materials and to control costs. These materials are then used to create the device components. Cell manufacturing, a manufacturing approach in which equipment and workstations are arranged to facilitate small lot, continuous flow production, is part of cGMP. In a manufacturing cell, all operations that are necessary to produce a component or sub assembly are performed in close proximity, commonly in a U-shaped configuration, allowing for rapid and continuous feedback between operations. Workers in medical device manufacturing cells are typically cross-trained and able to perform multiple tasks to aid in efficiency. Cell manufacturing also allows for close oversight of the medical device manufacturing process and agile response when adjustments must be made in any given step as issues arise.
Medical Device Component Creation
Medical device component creation can take several forms. Some parts are injection molded from plastic. Others are more suitable to creation through extrusion, where melted plastics are pressed through a die to create the appropriate shape. The choice of which process to use in any medical device manufacturing process is often determined by the physical properties of the material. Extrusion techniques work best on materials that have high viscosity when melted, while molding is more appropriate for materials with low viscosity. Additional material can also be added to raw materials to alter viscosity or thermal properties or to lubricate the material. After extrusion or molding, the components may undergo additional shaping through other processes.
A recent innovation that has major implications for medical device manufacturing is the advent of 3D printing. Currently, 3D printing is primarily used for the rapid prototyping of devices. A few products — such as customized splints, medical instruments, and some implantable devices — have already been approved for use with patients. Doctors have been using printed models of human organs to plan surgical procedures. Researchers are already exploring the additional possible medical applications of 3D printing, and technological improvements will mean increased product quality and decreased costs for medical devices that manufacturers. Prosthetic limbs, bone replacements, and even artificial organs may soon become a reality. The FDA’s Center for Devices and Radiological Health is continuing to develop quality control standards for 3D printed components that medical devices that manufacturers will need to be aware of and follow.
The processes involved in medical device manufacturing must be incredibly precise while being delicate enough not to damage the instrument. Physical connections, while small, must still provide the appropriate level of mechanical strength. Processes must therefore be tailored to suit project needs. For example, multiple types of welding are often employed in medical device manufacturing. Ultrasonic welding can be used to weld plastic parts. It produces an efficient, clean weld that doesn’t introduce additional materials in creating the bond. Tungsten inert gas (TIG) welding is employed to join thin, non-ferrous metals. TIG creates a strong bond that doesn’t change the composition of the materials at the weld point. Resistance welding joins metals by heating the connection point with electrical charge. Different types of resistance welding can create joints that vary in the level and types of strength. Some create strong tensile strength, others create strong peel strength, and still others provide sheer strength. The choice of which type to use is determined by the mechanical needs of the device. A final form of welding often employed in the medical device manufacturing arena, laser welding, joins material using a focused beam. Lasers are an excellent choice for performing welds in constricted spaces, as the beam can pass through the smallest apertures to reach its target.
Medical Device Software Development
Some medical devices are non-electronic or are intended to be connected to existing hardware. Increasingly, however, medical devices include integrated microprocessors that control their function. In these cases, software development becomes part of the device creation process. Proven Process Medical Devices can develop software in most major languages, including C, C++, C#, Visual Basic, and most assembly languages. The company is are also able to create the printed circuitry and program the integrated circuits for operation with for these medical devices. Many medical devices today are able to send and receive communication wirelessly, requiring MICS, Bluetooth, or 802.11 integration. Proven Process has extensive experience with such devices.
Medical device manufacturers are required to comply with software standards that ensure the quality and reliability of the medical device’s operating system. IEC 62304:2006 is the international standard for medical device software. In addition, medical device manufacturers must meet the standards for the specific markets in which the device will be used. Many countries accept compliance with IEC 62304, but others use internal standards instead of or in addition to the international standard. For the U.S., this means meeting additional guidelines and directives from the FDA. The EU outlines its regulations in Medical Device Directive 93/42/EEC, the Active Implantable Medical Device Directive 90/385/EEC, and the In-Vitro Diagnostic Medical Device Directive 98/79/EC.
Naturally, quality control is implemented across every step in the medical device manufacturing process from the creation of raw materials to the manufacture of the finished product. The ensure that medical devices meet the highest standards in material, manufacturing, and performance, medical device manufacturers implement rigorous testing protocols. Mass spectrometry leak detection, emissions and immunity tests, and similar processes confirm that the material and assembly fall within targeted performance ranges. Operational compliance is determined by subjecting the medical devices to batteries of testing to determine whether they perform as they should. If the device is a new product, it is then submitted to the FDA for final approval.
The final stage of the medical device manufacturing process is the packaging of the device. A number of factors are taken into consideration when determining the type of packaging to use including the fragility of the device relative to how it will be transported and used. Delicate instruments can require complex cushioning not only to protect them from possible impact but also to dampen any vibrations experienced during transportation that could affect internal componentry. Another factor to consider in packaging is the sterile condition of the device. Some devices will be sterilized before use on patients, while other devices will be used straight from the packaging. Appropriate steps must be taken to ensure both the initial sterile state of the device and the protection of that state during transportation.
Results Built In
As an ISO 13485:2012-certified, FDA-registered contract medical device manufacturer, Proven Process Medical Devices takes concepts to reality in our scalable, cGMP-compliant manufacturing facility. Our facility features more than 20,000 square feet of manufacturing space, a Class 10,000 clean room, as well as model and prototype assembly labs. Oversight of supply chains is carefully managed for optimal costs, and the highest safeguards in documentation ensure lot control of raw materials. We have the talent and the resources to take your project from pilot to full-scale manufacturing with comprehensive and stringent project management oversight every step of the way.