Challenges for medical device manufacturers

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Medical device manufacturers have their work cut out for them in such a stringent and competitive industry. There are so many rules and regulations to follow to ensure that medical products are safe and ready to be used. In a sector with so many procedures that need to be followed, the challenges for medical manufacturers are never ending. We are going to explore a few in this blog. 

Regulatory Compliance

Navigating regulatory requirements is a very common challenge, especially for manufacturers who export products to international markets. Even those who stay domestic are often faced with constantly evolving standards and requirements. 

To handle this, manufacturers have to constantly check for updates from organizations like the FDA and EMA. If products need to meet specific standards, manufacturers have to be up to date and can’t afford to miss anything as it could cost big money or put the company at risk of being prosecuted. 

(Having a team focused on compliance can help make sure their devices meet all the rules before they're sold.)

Quality Control

It’s no surprise that medical equipment must be held to high quality standards. The challenge lies in maintaining consistency across all production batches. There is no end to the factors that could affect a batch, from different people being involved in processes to an unexpected event that alters the routine of production.  

It is impossible to control every potential factor 24/7 but if the final product deviates from the usual standard, it becomes costly and time-consuming for manufacturers to source and fix the problem. 

This can be avoided by implementing a quality management system (QMS), regularly training staff on the importance of quality control, and ensuring that this is integrated into manufacturing processes. Being proactive is much easier than having to backtrack to fix issues later. 

Technological Advancements Mid-Production

Another challenge that medical device manufacturers may encounter is technological advancements emerging mid-production. Developing new and innovative products is time-consuming which isn’t ideal in such a fast-moving industry that sees constant technological developments.  

The process of research, development, and manufacturing takes time. It’s not unheard of for new technological advancements or requirements to appear midway through production, meaning a team may have to pivot to meet these new standards or use new technologies to stay competitive. 

To avoid this, many manufacturers use agile processes when running a project. Doing so exposes the team to the possibility that changes may happen, increasing adaptability if something does occur, without causing substantial disruptions to the project timeline. 

igus® medical device manufacturing 

Our products cater to all areas within the medical industry, specially designed to suit the requirements of this sector and produce the medical devices they need. At igus®, we know that products in the medical industry must fulfill the highest hygiene standards. igus® sells grease-free and corrosion-resistant plain bearings and linear guides made of high performance plastic. These igus parts are used in imaging equipment, laboratory devices, and in many medical furniture products

Also, we produce maintenance-free e-chain cable carriers used for the protection and guidance of cables, e.g. in operating theater devices, rehabilitation systems and imaging diagnostic equipment. All these components have cleanroom-compatible versions, are chemical-resistant, and quiet running. 

Infographic: Medical & Contact-Free Automation Industry

We don’t just provide medical devices as we always stay up to date with changes in compliance standards for all the industries we supply to and can offer a wide variety of FDA-compliant products which you can read more about here.