MedCity Influencers, Devices & Diagnostics

The Importance of Quality Assurance for Customer-Centric Medical Technology

Having a streamlined process to get customer feedback, adhere to regulations, and automate processes not only helps make sure a business delivers the best quality products, but also helps ensure that customers are satisfied.

Customers are at the center of business, and in the medical technology space quality assurance reigns supreme.

Quality assurance looks at a company’s services or products to make sure everything is running efficiently and up to par with what is desired and mandated by an industry. When this process is streamlined, quality assurance provides a significant benefit to both the consumer and the business.

For a company, quality assurance provides an opportunity to create efficiency in the business model. For customers in the medtech space, quality assurance can improve patient safety, effectiveness and user experiences, while also ensuring they are getting necessary outcomes at a fast and accurate pace.

Improving user experience with products can then translate into loyalty for the brand. When companies know what customers want, they can use that to innovate and keep people coming back for more.

Innovation is key. The customer is number one.

Without innovation everything is stagnant. Nothing evolves. Nothing improves. In the medical field where everything constantly changes, innovation is of utmost importance.

One way to figure out what could be the next big innovation is to listen to your customers.

Monitoring customer feedback and vigilance about a product goes both ways. It can be positive or it can be negative. Both are useful for the business to hear. A business can take that input and then make adjustments to the product to better optimize the user experience.

In addition, customer feedback is an integral part of quality control checks. In medtech, feedback is crucial. It is important that all medical devices and technologies work properly and efficiently for the user. A business wants – and needs – to know what is working and what isn’t.

If your customer is using a hearing aid, and it breaks after a few uses, there could be a structural issue with the specific device, or it could be a bigger manufacturing problem. Being able to listen to that feedback, pinpoint the problem, and look into a solution is important.

Having that direct line of feedback to make necessary adjustments is a win-win for the customer and the business.

Is it functioning at the high level that it was designed in the research and development (R&D) to achieve including user needs? What can be improved to better satisfy and improve patient outcomes? Did one part of the device malfunction or break? Can that malfunctioning part be replaced, or is it a bigger manufacturing issue in the supply chain?  These are all necessary and important questions to address.

Performing quality control checks on products is integral in the future developments of the products. Being able to control and streamline how a business will respond to changes will resolve issues quicker and more smoothly.

Follow the regulatory mandates.

Our environment is constantly changing. Technology is being updated, and new laws are being passed every day. It’s important to make sure medical devices follow all regulatory mandates.

Furthermore, quality R&D and regulatory oversight must work together in developing a product to make sure all needs are met. Having a well-documented product lifecycle can help streamline the process and keep everything in check from all angles.

Businesses working in the medical device space must not only be financially compliant, but also regulatory agency compliant across the board. Regulatory compliance ensures products have been tested to make sure it’s effective, safe and have the proper usage directions laid out for the customer.

Following all mandates and government guidance is necessary and advised.

Automation increases accuracy.

Automation can lead to more accurate results by reducing variability and increasing the overall quality of the system. It can also help ensure your company stays compliant with regulatory mandates.

If a business has an organized system, it can improve supplier management and help the business operate at an optimal level.

All in all, quality assurance helps a business make sure its process meets the standards and regulations of an industry – a key component in medical technology. Having a streamlined process to get customer feedback, adhere to regulations, and automate processes not only helps make sure a business delivers the best quality products, but also helps ensure that customers are satisfied.

Photo: marchmeena29, Getty Images


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Chuck Serrin

Chuck is the VP of MedTech and Life Sciences Industry Marketing at Propel Software. Formerly, as a Solution Architect and Program Manager at Stryker Corporation, he implemented and supported global PLM, QMS, and digitalization projects. Chuck has deep domain expertise on the development, compliance, and commercialization of medical device products, along with providing high-quality support in launching new products. Over 20 years of experience across senior positions in enterprise software solutions with companies such as Agile Software, Oracle, and PTC.

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