This article points out the inevitable challenges that medical device manufacturers face in ensuring the quality of products and gives some useful hints to solve them.

The global market of medical devices has been growing at a rapid pace and is predicted to grow at a steady rate. This is mainly because of the advancements continuously made in the healthcare field to serve the patients’ needs. However, this has also created challenges for the manufacturers as they could not fuly keep pace with the emerging technologies while focusing to maintain the quality of devices and serving the needs of the patients. This article highlights the key challenges that medical device manufacturers are facing and tells how the right approach to quality management like ISO 13485 standard could save them.

ISO 13485 is the quality standard for medical device manufacturing which outlines guidelines for manufacturers to establish a Quality Management System (QMS) and meet the mandatory regulatory requirements as well as patients’ needs. The QMS will help a manufacturer to ensure consistent manufacturing processes and deploy certain best practices to overcome the challenges. Let’s find out how.

5 Challenges in Medical Device Manufacturing that an ISO 13485 QMS Helps to Overcome

Compliance with Regulatory Requirements

It is compulsory for medical device manufacturers to follow all the applicable government regulations and industry guidelines to make their products viable in the market. However, if you are a manufacturer, you can understand how difficult it is to achieve compliance with each requirement. They are not only complex but also undergo changes continuously. Therefore, it will always be challenging for you to maintain compliance and assure that your devices sell in the market.

The ISO 13485 standard will help you overcome this. It needs you to implement the QMS by understanding enough all the regulatory requirements and implementing practices to meet them. It also needs you to have an internal audit strategy through which you must review your processes at frequent regular intervals to find non-compliances against the latest requirements. Subsequently, you can take corrective measures and eliminate the issues.

Product Development

The processes of product development in the medical device industry are intricate as well as time-consuming. Also, new product development is always an integral part of the manufacturing organization. Thus, research and development continually take place which too needs lots of time and resources. In such a backdrop, focusing on the quality at every stage, right from conceptualization of the products to their realization is a tough thing. This results in higher operating costs as well as a longer time for the devices to reach the market.

The QMS will help you to comprehend the customer needs and plan the technicalities or features in the devices to meet them. It will ensure that the requirements of users (patients, physicians, nurses, etc) are well defined to the staff and they are provided with adequate instructions as well as training to develop the products accordingly.

Supply Chain Issues

The suppliers who provide the components, materials, and subassemblies to help you manufacture the finished devices play a vital role in quality management. The quality of their supplies determines the quality of your finished devices. Hence, it is important to involve the suppliers in your quality management strategy to ensure the delivery of superior quality, safer, and competent devices.

The 13485 standard necessitates supplier involvement as a key requirement for establishing the QMS. It needs you to maintain a good relationship with your suppliers consistently so that they understand your specific quality requirements. Thus, they will seek to meet them by improving their own production processes and supplying your good quality and reliable inputs.

CAPA (Corrective and Preventive Actions)

Medical device manufacturing organizations need to have specific CAPA (Corrective and Preventive Actions) procedures in place. It is necessary so that any issues through the manufacturing processes are resolved at an early stage with appropriate actions. However, integrating CAPA procedures into your vast number of processes is quite a challenge. The ISO 13485-based QMS provides a solution for this by ensuring better traceability of the processes. It promotes regular audit practices that help in finding the issues faster and addressing them with CAPA.

Drive for Continuous Improvement

The medical device industry has a continuous urge to innovate and continually improve its products’ attributes, technicalities, and quality. However, it is most difficult for the leaders of manufacturing businesses to find a coherent strategy to drive innovation, modify their devices, and address customer needs in a better way.

A QMS based on the international standard, ISO 13485 will help you to have a strategic approach to innovation and continuous improvement. Implementing it creates a focused culture of quality in your manufacturing organization where everyone is driven towards the same goals i.e., better quality of devices, speedy delivery to markets, and increased satisfaction of customers. This makes them continuously strive for new methods and improvised manufacturing techniques.

As competition in the medical device industry has increased, it is essential for manufacturers to deliver excellent products and stand out. With a QMS that is developed based on the ISO 13485 standard, you can easily overcome the most critical challenges and make sure that your overall product quality and safety are maintained. The above points explained how it will help you.

Author's Bio: 

Damon Anderson is the managing director of an established and accredited ISO consultancy that provides reliable consultation services to businesses to help them get certified with the desired standards. He is a specialized consultant for the ISO 13485 standard and has helped many medical device businesses to gain it. He likes to write blogs in his free time to share his expertise and knowledge of the standard.

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