Medical device manufacturing trends and challenges

Medical device manufacturing includes all areas of production of a medical device, from designing and developing a fabrication procedure to scale-up to continuous process improvements. The processes also include the sterilization and packaging of the final product for shipment.   

Products range from sensory aids, diagnostics, imaging equipment, implants, artificial joints, and many more.  The top companies in the industry rake in billions of dollars in revenue yearly. Therefore, to maximize success, industry players must make the beginning of the design phase of medical devices a priority.   

The industry includes more energy-efficient equipment and requires unrelenting knowledge about renewable resources, proficient methods that reduce waste production, and sustainable manufacturing components. Thus, the production process though rigorous strive to be more efficient and faster.

To attain the needed height, medical device manufacturers must use safer FDA-approved materials and incorporate improved strategies in the production process. In addition, using advanced technological equipment or machines will add value to the customers’ experiences and eliminate any activity geared toward wastage.

Future Trends to Watch ….

The common goal of medical device manufacturing is to protect the lives of patients and ensure the best standard of living in all ramifications. This aim is shown in the wonderful innovations the industry has witnessed in recent years. Are you surprised that medical devices are getting smaller, smarter, more efficient, and digital age-driven?

As these devices get smaller, producers require much high-quality medical wire component that possesses great features to sustain the future of medical devices. The fine wire should have excellent transmitting capabilities, the right strength and fatigue resistance, as well as more advanced sensing. But what are the future trends you should look out for?

Medical devices are going remote

What does the above assertion mean? Remote monitoring helps physicians and sick people track their health efficiently without the need for hospital visits except when it becomes necessary. Remote devices work by sending information to a computer or mobile phone where it can be checked and analyzed. Then, robust reading parameters can be configured for automated alerts should the patient become sick.

For instance, a glucose monitor is one of the major examples of a popular remote monitoring device. It has transformed the lives of diabetic patients all over the world. With it, sufferers don’t need to perform invasive tests but can receive alerts when their glucose level drops beyond the set parameters.

Therefore, remote monitoring can give people with heart issues or diabetes more freedom and peace of mind. It is indeed a lifesaving technology that helps with more rapid intervention. 

Medical device manufacturing is incorporating 3D printing and prototyping

Small batch prototyping can help manufacturers, especially the original equipment manufacturers (OEMs) to figure out the most ideal component for their device without producing waste. They can expand their prototyping capabilities to enable 3D visualizations. Of course, 3D visualizations could be transformed into 3D printed prototypes and even become injection molded in the nearest future.

Medical devices require RFID inclusion to increase traceability and transmission

RFID is utilized for medical devices to monitor the devices from the production stage. This helps to track important information such as maintenance requirements, device lifecycle, and sterilization. Moreover, RFID tagging can help doctors to access critical patients’ medical information through a scan, thereby preventing record mix-ups and the subsequent administration of incorrect treatment.

Most functional medical devices have some kind of RFID tagging to help transmit information easily and track the location of a particular device.

Medical device manufacturing is implementing automated production processes

Creating repeatable processes and a reproducible product is very important for manufacturing medical devices. It means adapting equipment to automate production processes. Besides, automated production processes guarantee uniformity. Though, to meet the tolerance levels set for certain applications, it’s pretty more accurate for humans to do the job manually.

Challenges Facing Medical Device Industry

The medical device production industry is still surviving even amid many challenges including navigating the tough and tight regulatory landscape and product recalls. Manufacturers have a lot to contend with to keep stakeholders satisfied and customers safe. But, to what extent have these challenges tried to halt the growth of the industry? Here, we consider some of these problems more widely.

There are many different stringent regulatory requirements to battle with

Since the production of medical devices entails the fabrication of essential tools for healthcare that have a direct impact on human life, the safety of these devices is paramount. Therefore, to get desirable outcomes and prevent product recalls, the manufacturing processes must follow several regulatory standards. The few most common medical device manufacturing standards are:

Medical Device ISO Standards

ISO 13485 – This standard is all about following a standard management protocol that shows that companies are committed to producing superior standard devices. It helps with risk management, product traceability, and overall quality control.

ISO 14971 – Compliance with this standard ensures the application of complete risk management to medical devices.

ISO 27001 – Cyber security has become an increasing concern to the more sophisticated medical device industry. The growing market for smartphone-dependent health-tracking apps needs information regulatory standards. ISO 27001 can help manufacturers access and manage cyber security challenges in their organizations.

There is the challenge of upholding high-quality manufacturing standards

The medical device manufacturing industry is a high-stake industry. Patients depend on safe and effective medical devices, as such the cost of poor standards can be drastic. Quality challenges are often seen in software, acceptable materials and components, and design technology. There will be issues if a medical device is produced and needs to be recalled later.

The entire manufacturing process could be shut down for a while if there are quality concerns. This can translate to costly delays. What about product recall? It can make the end-user angry and spell doom to the producers. Poor quality devices and product recalls are too expensive, including the lawsuits that destroy the manufacturer’s reputation.

Abandoning outdated processes and ensuring effective collaboration

It takes a lot of time to develop and produce a medical device. The time to review the product can run into months. In addition, if there’s any shift in the working condition, manufacturers may find it difficult to collaborate effectively. For instance, shifting to remote working at the beginning of the Covid-19 lockdown made it difficult for some medical device manufacturers to upgrade and update their production processes.

Though most device manufacturers have now embraced their remote working practices, they’re still battling with achieving quality standards and regulatory requirements. These things take ample time to achieve.

The challenge of cyber security

Digital practices have contributed in no small measure to improving the medical device manufacturing processes. However, some innovations and technological advancements undermine security. The Internet of Things (IoT) helps devices to communicate with each other so that they can generate useful data, as well as send and receive the same via the internet. 

The industry is committed to protecting the sensitive data of end-users, as such cyber security is a top priority for them. They have backup plans should there be any incident of a data breach. This can negatively impact production costs and even delay getting FDA regulatory approval.


The sole responsibility of the medical device manufacturing business is to design and produce different kinds of products that are used to diagnose and treat ill health and boost the overall health of the patient. Though the economic potential is much, the industry requires the collaboration of professionals to meet the yearnings of both the direct users and regulators such as the FDA and other regulatory bod.

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