Top 3 Challenges for Medical Device Manufacturers

Top 3 Challenges for Medical Device Manufacturers

20 Apr 20214 min readMike Anderson
A chess game, representing challenges for medical device manufacturers A chess game, representing challenges for medical device manufacturers

The COVID-19 pandemic shone a spotlight on the medical device industry in 2020.

Luckily, the industry met the challenge by developing and manufacturing diagnostic kits and critical personal protective equipment to push the world through the crisis.

It is important to consistently keep an eye on the horizon so the industry can prepare for whatever comes next. In this post, we discuss what we believe will be the biggest challenges for medical device manufacturers over the next few years.

Global Supply Chain Logistics

ATL operates manufacturing facilities across the globe.

When COVID-19 began to spread, and businesses and ports were closed overnight, we saw first-hand just how fragile the global logistics ecosystem is and how easily it could be disrupted.

A year later, in March of 2021, the world experienced another shock when a freighter became lodged in the Suez Canal, preventing shipment through a precious maritime channel. As many medical device manufacturers build and ship their products globally, establishing robust supply chains has become a priority for most organizations.

Concepts like reshoring, nearshoring, and onshoring have become popular topics throughout the industry. With more and more countries growing, connecting, and establishing interdependencies, global supply chain risk will continue to increase.


Our blog post about connected medical devices discusses how cybersecurity has become a growing concern among medical device manufacturers.

The ability to connect medical devices to the internet and have patient data accessible from anywhere in the world in real time has helped improve patient outcomes globally. However, the explosion in connected medical devices has made the Internet of Medical Things (“IoMT”) a prime target for bad actors.

In 2020, a cybersecurity vulnerability called Ripple20 was found in millions of devices across the Internet of Things (“IoT”)—including critical medical devices. This is just one of many cybersecurity issues, breaches, and vulnerabilities identified by the industry and its governing bodies.

With cybersecurity threats rising, the FDA recently appointed its first medical device cybersecurity chief, while many medical device manufacturers have begun hiring cybersecurity experts.

Quality and Design Risk

Over the past few years, a handful of high-profile medical devices have been removed from the market by legal action or government intervention.

Though the medical device industry is held to some of the most stringent standards in the world, no product line is without risk. Ensuring that products are designed and manufactured in compliance with international and domestic regulations is a challenge with which the medical device industry has always had to grapple.

Maintaining quality standards as a company grows and a supply chain begins to stretch is a daunting task with which even the most well-known medical device companies struggle. Though no product failure or defect is by any means a good outcome, the medical device industry is always learning, so each time a product doesn’t work as intended, it is used as a case study to improve the entire system.

As devices become more complex and precise, the design and quality challenges facing the medical device industry will only continue to increase.

Additional Resources

Uncertainty about the future exists in every industry and market. However, knowing the trends of the market and the challenges other organizations are grappling with can put you in a better position to succeed.

To learn more about our approach to medical device risk management, please download our ebook here.


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