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Over the last few years, we’ve witnessed rapid growth and major innovations in the medical device landscape. According to market research conducted by Fortune Business Insights, the overall market for medical devices is expected to touch USD 657.98 Billion by 2028. We’re seeing significant contributions not only from large enterprises like Medtronic, Abbott, Siemens Healthineers, and GE Healthcare but also from a wide range of VC-backed startups.

We’re witnessing potentially game-changing partnerships; For instance – GE Healthcare partnered with Nvidia to bring an extremely advanced AI platform into highly complex medical devices, all with the goal of improving patient safety. Apple Watch 4 is an FDA Class 2 Medical Device that can detect heart rate, falls, or trips, among other parameters.

Overall, there is serious innovation happening through a combination of hardware and software breakthroughs – even as regulators are keeping pace to ensure patient health and safety above everything else.

Medical devices form an essential part of the treatment procedure for almost all health conditions, playing a significant role in various aspects right from diagnosis to therapy. It is essential to ensure their effectiveness in meeting the intended objective and also be safe to handle.

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Medical devices may contain many electronic parts and/or components to perform chemical analysis and it often uses electricity. Most of them are handled by diagnostic staff, nurses, attenders, and other humans during the treatment procedure. The patients definitely come into close contact with the devices, some of which may even be inserted into the body or placed on the surface of the patients.

Mitigating Risks Across Three Dimensions: Patient Safety, Regulatory Compliance, Business Performance

Keeping all this in mind, it is critical that medical device company does whatever it takes to ensure the safety of the device. The safety process used by the company must take into account all the use-cases and be optimized for various people who come in contact with or close to the device – the person operating the device, patients, doctors, para-medical staff, lab technicians, etc.

Therefore, the safety solution for your medical device must come with integrated risk management capabilities.

To ensure that only safe devices are used, the Food and Drug Administration and other similar regulatory bodies delineate regulations that must be complied with at every stage of the manufacturing process. This increases the safety effectiveness quotient of the device.

Medical devices can be placed in the market only after being vetted by the regulator. Any non-compliance or serious undetected health hazard can cause the device to be recalled. This will impact the business performance in terms of the costs involved and brand reputation. The costs can come in many forms:

  • The direct cost of a recall
  • The cost of rework
  • The cost of delaying treatment or diagnosis
  • Litigation, penalties, and compensations that the company has to pay for in case of a recall or an event
  • Loss to life or injury
  • The subsequent loss of brand reputation leads to loss of business

The lifecycle of a medical device manufacturing process is long and needs significant investment for research, design, manufacturing, testing, and so on. Therefore, an event like a product recall lays waste all the effort that has gone into its production and other stages before that. If the device cannot be reworked, it may have to be scrapped and the wastage adds to the cost. The process must begin from scratch, which involves time and investment.

It is in the best interest of the patient, the handlers, and the manufacturers that the device is manufactured right the first time. However, even with the best of intentions, mistakes happen and the device may not be compliant and safe.

4 Key Safety Factors to Remember in Medical Device Manufacturing

Some of the factors to keep in mind in the manufacturing of medical devices to ensure their health and safety include:

Data-Backed Design: Human beings are unpredictable and each user of a device is different from the next. Since devices need human interaction and how that interaction happens can impact the safety quotient of the device, research into comparable products, their designs, risks, and other such data are important right at the design stage.

This, along with other factors such as the best material to use, other design aspects, the right set of suppliers, and the ideal manufacturing partner, all require data to make an informed decision that will improve the device’s safety. Data can be obtained from regulatory agencies and independent bodies. This can be supplemented with research by the organization to fine-tune the product and make it unique.

Testing Before Release: Once the product is ready, it must be tested under various conditions to ensure its stability and safety. In today’s globalized world, the device may be used anywhere from Alaska to Australia, in all kinds of weather conditions, with varying levels of electrical and network connectivity, etc. The device must have a consistent performance under all these varying conditions and, more importantly, be safe.

Post-Market Surveillance: The journey does not end after releasing the medical device into the market. Customer feedback and performance tracking are essential to ensure that the device is indeed achieving its purpose in a healthy and safe manner. This is important to fine-tune and continuously improve the product. Any negative feedback should be handled appropriately and action must be taken immediately to improve the design and performance.

Documentation and Risk Management: Documentation and follow-up are very essential, especially in large markets such as the US, Canada, and Europe, to demonstrate compliance with ISO 14971. Documentation and implementation of systematic risk management processes throughout the product lifecycle are essential for this.

ComplianceQuest Safety Solution for Safe Medical Devices

For device manufacturers, safety management can become a challenge as they try to balance the cost and time of innovation and the product lifecycle. Safety may often seem like a hindrance to faster growth and compliance may become lip service, just enough to keep the regulators happy. Often this is because the safety management systems are manual or legacy systems – and access to data to make informed decisions, and implement root cause analysis, or CAPA may become difficult.

A cloud-based safety solution such as ComplianceQuest provides a holistic view of organization-wide data by seamlessly integrating with systems such as ERP, CRM, and so on. It is a flexible, modular, next-gen solution that facilitates safety leaders and production teams to identify risks, put controls in place, and reduce or eliminate the risks.

As the data is documented, it helps with reporting and also labeling so that precautions can be elucidated to prevent mishaps. This documentation also helps with correctly classifying the risk category the product belongs to right from the beginning. Any feedback is ingested and processed, providing the safety leaders with the opportunity to incorporate the feedback to improve the safety and usability of the device.

Additionally, CQ EHS integrates with our EQMS and Design Controls Solutions, which may be an ideal solution for your organization.

To know more about how the CQ Safety Solution can help your company’s health and safety team, visit: https://www.compliancequest.com/industry/medical-devices/

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