February 24, 2022

Quality Assurance: A Critical Priority for Medical Device OEMs

Medical devices are essential in the prevention, diagnosis, treatment, and rehabilitation of illness, enabling healthcare professionals to improve the lives of millions each year. The World Health Organization estimates that there are two million different kinds of medical devices in the world, classified into seven thousand different device groups. OEMs are faced with many challenges in bringing these life-saving devices to market—and Contract Manufacturers can help to overcome these, and provide many other benefits as well.

Medical Devices: Making Healthcare Possible

These devices are used to treat a wide variety of ailments not only by doctors in clinical settings but by healthcare providers in remote and austere environments, laypersons at home and work—in short, many individuals and organizations around the world for a wide variety of purposes.

From diagnostic procedures to the delivery of life-saving medications, these devices are critical to a professional’s ability to provide adequate care and in many circumstances are instrumental in keeping someone healthy. Their proper functioning is of the utmost importance to anyone who relies on them.

The Strongest Link in the Chain of Custody

Every step of the process that delivers medical devices to people who depend on them is essential to guarantee they function effectively. From assessment, acquisition, implementation, and management at one end of this continuum to design and manufacture on the other, the utmost precaution must be exercised.

This is especially true regarding original equipment manufacturers, who must undertake stringent efforts to ensure each device they are responsible for functions as intended every time its use is called for. If a medical device malfunctions, it could be much more than an inconvenience—it could quite literally be a matter of life and death.

In the event of such a malfunction, steps must be taken to determine what went wrong. Remediation efforts rely on accurate information, and strict regulations require the reporting of any significant adverse event. Exact requirements must be met in reporting, and these can be complex and challenging to understand, even for industry professionals.

The Devil in the Details

No one can be an expert in everything. Engineers have one specific skill set, doctors have another, and there are areas of specialization within these fields. Highly trained professionals may be at a complete loss when confronted with a problem outside their expertise.

Regarding adverse event reporting for failed or malfunctioning medical devices, it may not be possible for some of these professionals—even the engineers who designed a device—to ascertain causes of failure or what could be done to eliminate a possible fault.

Failure to report thoroughly, accurately, and completely may result not only in insufficient efforts to remedy a fault but could lead to avoidable injury. Knowing what information to convey—and how to discover it—can be a challenge whose failure brings with it lethal consequences.

Alleviating Problems with Quality Assurance Efforts

This is where quality assurance plays a significant role. By preventing flaws in the manufacturing process underlying both legacy and novel medical devices, QA not only guards against defects and ensures the best chance at attaining the highest level of quality, but also solves these problems. Having dedicated expertise in various aspects of the manufacturing process means there will be specialized oversight that can help address issues inherent in this field—like adverse event reporting.

QA efforts focus not only on preventing flaws in manufacture but also look for potential problems in processes that may result in nonconforming products. Taking place throughout every step of a product lifestyle, QA maintains correct processes and procedures and strives to identify areas of potential improvement. This applies not only to manufacturing processes but product development and many other various factors involved in the successful manufacture of medical devices.

Many Challenges, Many Concerns

Though perhaps most serious, adverse event reporting and its requirements represent just one of the challenges medical device OEMs face. They have to contend with supply chain issues, rising costs for equipment acquisition and maintenance (which is a recurring expense), and other logistical demands that are time-consuming and expensive.

It may seem crass to speak of expenses when discussing such an important subject, but all businesses must stay profitable to continue to provide their product to the public. Medical device OEMs are faced with protecting their profit margins, which are often already narrow due to the nature of their products, typically niche offerings that may not benefit from economies of scale.

These are just some of the challenges faced by medical device OEMs. Others relate to the innovation of new technologies, harnessing the benefits produced by digital transformation, integrating recent advances into legacy equipment, implementing Industry 4.0 business models—and a virtually never-ending list of factors, all of which limit an OEM’s ability to achieve success.

Breaking the Bottleneck: Medical Device Contract Manufacturing

Just as QA efforts address many of the concerns around possible flaws in medical devices and the issues their manufacturers may face, contract manufacturing services address these additional concerns as well. Handling QA challenges is only part of what CM entails.

CM ensures stringent QA procedures of the highest caliber are maintained, but also excels in reducing costs, enhancing security, meeting the challenges of modern logistics and supply chain management, and much more. Expert-level CM services address these additional concerns as well by alleviating problems inherent in every aspect of the manufacturing process.

Sanbor Medical: Exclusive Medical Device Manufacturing

Medical device contract manufacturing ensures an OEM has the benefits of multidisciplinary expertise, flexibility, risk reduction, superior QA efforts, and much more at substantially reduced costs. These benefits aren’t limited to monetary concerns or operations. Freed from the burden of having to account for all of the secondary factors, a medical device OEM organization can focus on what they do best—innovation in meeting the needs of the medical field, which benefits us all.

Sanbor Medical has the technical experience and quality procedures you’re looking for. Contact us, and one of our industry experts will work with you to bring your product to market quickly, efficiently, and affordably.



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