Contract manufacturing
Microfluidic technologies, a feature of many medical devices, are also shaping how medical devices are manufactured. Scalable microfluidics allows for continuous synthesis of nanoparticles, like plasmonic nanomaterials used in emerging diagnostics. Another prominent technology is the continuous production of nitinol tubes, a superelastic and shape-memory material.
Continuous draw methods provide an uninterrupted supply of these tubes, speeding up the production of a wide range of medical devices like stents and catheters. Automation and robotics are amplifying the speed of these technologies, yielding further efficiency gains for continuous manufacturing.
But not all medical devices can be made continually. The more steps involved in making a device, the harder it is to automate. “If you need to assemble a lot of parts, ultimately everything comes to a stop in the cleanroom where a manual operator has to handle the device,” says Vanhoestenberghe.
“Improvements in automated visual inspection for medical devices could potentially increase the range of products that can be manufactured using continuous manufacturing.”
Anne Vanhoestenberghe
With highly precise assembly machines, many medical devices can now be made with little or no human assembly. By reducing steps that need human intervention and ensuring that fewer parts are rejected by quality control, high-speed, high- precision assembly enhances the viability of continuous workflows. An important bottleneck, however, is testing the medical devices as they are manufactured.
“Improvements in automated visual inspection for medical devices could potentially increase the range of products that can be manufactured using continuous manufacturing,” says Vanhoestenberghe. In the other direction, continuous manufacturing of high-quality, precise parts speeds up assembly of medical devices.
Lessons from pharma manufacturing While contract manufacturing has been mainstream in pharma for decades, continuous manufacturing processes are relatively recent in that industry as well. Pharma manufacturing is more amenable to continuous operation because manufacturing therapeutics typically doesn’t require discrete assembly or fabrication steps. “For radioisotopes, which have to be manufactured on demand or drugs
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that have to be patient-specific, batch production is the preferred mode,” says Vanhoestenberghe. But even for therapeutic products that require some assembly or are made to order, the pharma industry has had some success with continuous manufacturing. These have been possible largely due to modular manufacturing platforms, flexible supply chains, and integrated development and manufacturing approaches. By adopting these trends, medical device companies too can achieve faster product iteration and development, and smoother regulatory approvals. Lastly, medical devices with the greatest risk, such as surgical valves and defibrillators, require clinical trials before they are approved. Medical device companies can learn from how pharma clinical trials have made use of continuous manufacturing concepts like adaptive supply chains and flexible manufacturing methods. Additionally, unlike in pharma, iterative clinical trials are the norm in the medical device industry. Insights on how a device performs in clinical settings are brought back into the development of future iterations. Since continuous manufacturing allows medical device companies to develop product variants faster, it can speed up the iterative cycle and shorten clinical trial timelines.
Improved regulatory compliance Regulatory compliance can feel like ever-shifting goal posts for medical device manufacturers. The regulations governing medical devices, particularly in Europe, keep changing with new trends in healthcare and sustainability, and other macro factors. Often, these shifts necessitate an adjustment in manufacturing processes, which can prove disruptively costly for smaller medtech companies. Continuous manufacturing makes medical device companies more resilient to these shifts. By integrating real-time quality monitoring throughout manufacturing workflows, manufacturers can achieve continuous quality monitoring. Instead of testing a few samples per batch, this approach validates the safety and quality of devices as they are produced. This reduces operational risks, improves regulatory compliance, and delivers more value to the patients. As more medical device manufacturers turn to continuous manufacturing workflows, the industry could benefit from improvements in sustainability, material efficiency and device safety. But, for the most impact, continuous manufacturing should be accessible to medical device manufacturers of all sizes. “What we need is a bridge between batch- based manufacturing and CDMOs that implement continuous manufacturing once the numbers justify [it],” says Vanhoestenberghe, “and different types of CDMOs suited for different scales.” ●
www.medicaldevice-developments.com
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