Medical device manufacturing process

medical device manufacturing

The medical device manufacturing industry caters to healthcare solutions innovatively and competitively. They are designed to help in various stages of healthcare process viz; therapeutics, monitoring, and diagnostics. The overall process in the medical device manufacturing facility encompasses the journey from a design in the boardroom to the safety package of the final product. Medical device manufacturing processes can be broadly classified as the Industry Sector and Technology/Process. The industry sector includes manufacturing processes like casting, machining, and molding for producing Orthopedics, Diagnostic and Surgical Instruments, Cardiovascular, Dental, and Diabetes Instruments. Technology includes Quality Systems, Assembly, Lasers, 3D Imaging, Micromanufacturing, Nanotechnology. 3D Imaging helps in custom engineering of additive medical devices.  Failure Mode and Effects Analysis (FMEA) contributes to the Quality systems thereby maintaining consistent quality. 3D imaging contributes to the replication and manufacturing of smaller and sensitive medical equipment. These ever-evolving processes and technology have enabled the industry to cope up with new market challenges and demands. It has created new opportunities that have immensely expanded the contract manufacturing sector in recent times. Medical device manufacturing has undergone a drastic change with decentralized marketing, helping cater to scalability and customized demands.

“LeapFrog” Guideline

       Medical device manufacturing processes unlike others also have to strictly adhere to emerging environmental issues, material processing, utilization of renewable energy, and other important insights. They are poised to behave as responsible corporate entities constrained by ethical codes and environmental laws that complement their health care goals. Sustainability, usability, and user-friendly features of the equipment is critical for scalability and wider application. These challenges are solved through a dedicated thought body that combines technological processes that constantly gets improved and updated based on international healthcare medical manufacturing guidelines (FDA). The approach is extended up until the last stage of packaging. These institutions also work to provide a comprehensive regulatory pathway in parallel to technological advances, to drive innovations.

The technical guideline to effective medical manufacturing is profoundly called “LeapFrog”, the ideal is to enhance the innovation without compromising the ethical code of conduct. The earlier proposed “Good Manufacturing Process” (GMT) was meant to provide guidelines for effective manufacturing, which were static. The assessment was extended to an array of other medical equipment, constituting a leapfrog like development. This has been gradually implemented in the manufacturing of simple items like bandages to high-end digital devices.

 Lean Philosophy in Medical Device Manufacturing Process     

The development of medical devices employs risk management more than any other industry. The medical industry requires stringent regulation with constant and careful documentation at all the levels of the manufacturing phase, these practices are also required to be approved by the quality and health tech regulatory authority. This is where Lean philosophy helps in implementing conducive policies. The process of constant documentation and reporting makes the procedure efficient and effective compared to predecessors. Quality System requirement as propagated by FDA in health tech’s early day had to lean towards procedural methods which operated around a fixed set of mandates. It was generally agreed than process structured organization was more effective. Its ability to combine risk management with quality management made it a better contender. The recent change in health tech contributed by some bold start-ups are beginning to combine cutting edge technology with tested-tried manufacturing principles. Competitive prices and ever-expanding markets have opened the stage for innovation which was previously unseen. The compliance clause was imposed from the initial stage of manufacturing, where “Lean” was considered a crucial set of philosophy. The case of Toyota, which emerged as the largest automobile manufacturer of Japan, reaped the benefits of cutting waste and thereby increasing the product quality while significantly reducing the production cost and time.

       One of the biggest challenges in medical device manufacturing is to optimize the workflow in the final phase of product development. This chaos in the final assembly area is the result of constant product changeover amongst various other products. Traditional workstations required a common assembly area for the final product making the accounting and processing phase difficult to track and maintain.  Lean principle eliminates this by allocating separate workstations for high volume medical devices, which significantly reduces the processing time. This negation in complications also helped in reducing the calibration process.

 Research and Innovation in the manufacturing of medical devices.

         Innovative solutions in health tech are combining traditional medical device manufacturing with cutting edge consumer electronic technologies, digital marketing, and platforms. This has eventually led to an entirely new realm of healthcare products and solutions that makes pricing, distribution, ease of use, and scaling effectively. The synchronous between academia and industry has diminished the gap between consumers and products effectively. Earlier, medical devices were strictly available to medical practitioners and health care institutions which is now likely to transition as emerging health tech devices are increasingly exposed to consumers directly. This choice and trust that medical devices have acquired can be accredited to the safety principles they adopted. Medical devices are increasingly playing the role of preventive care, along with other advanced health care devices that health care institutions are adopting. The medical industry also depends on basic medical research more than other industries and more universities are extending licenses to health tech manufacturing firms. Start-up companies are playing a crucial role in coming up with unique healthcare solutions, it is evident from the fact that most medical devices were developed by start-ups than traditional big names in the industry. Regulatory systems play a great role in regional dominance, the US is known to have strict policies which have made Europe, China, and India an attractive destination for medical device manufacturing. The current scenario stressing on product design and simplicity contrasts greatly when compared to the traditional medical manufacturing industry. This is achieved because of the increased penetration of advanced software and technological processes.

 The Rise of Medical Device Manufacturing Automation

       Technological advancement in software, imaging, and electronics has initiated the rapid development of new medical devices, tools, and diagnostic equipment. Automation in the medical device manufacturing facility has proved to improve product quality and variability, it also has significantly reduced complexity in the workstation. Automation combines state of the art sensors, actuators, and cameras to produce error-free and failure detection medical product development models. The model has also proved to be effective in following medical device manufacturing FDA regulations. It ensures precise and repeatable results with the help of advanced automation components. Likewise, the model provides an efficient cost reduction model and enhances the production scaling without incurring extra costs. The automated medical device manufacturing process significantly reduces the labor and training module guaranteeing major product volume.

       Typically medical design and development process is a complex system needing to comply with various specifications, safety standards, health care guidelines, and end-user needs. These factors play an important role in devising optimum medical device engineering, which must be well balanced before plunging into the market.

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