4 Medical Device Trends Quality Professionals Need to Know

The world of medical devices can move quickly. Advances in technology mean that our medical devices can now connect to apps on our phones and software as a medical device (SaMD) is now helping doctors diagnose patients. However, other areas in the medical device industry aren’t quite so quick to change. Regulations for these devices change at a very slow pace, but even so, keeping up can be difficult. Ensuring effective and high-quality devices that pass regulatory inspection rests on the shoulders of quality and regulatory affairs professionals.
 
It’s impossible to know exactly what’s going to happen in the future, but medical device companies can take steps now to ensure that they’re agile and able to adapt quickly. Here are four trends that indicate where the industry is headed and how to prepare.

1. Changing Quality Regulations

The European Union (EU) has passed the implementation date for the new Medical Device Regulation (MDR). However, things became more complicated when the United Kingdom left the EU. Now, EU MDR still applies to all EU member countries, but if those countries intend to do business in the UK, there’s another set of regulations to comply with. The CE mark will only be valid in the UK until June 30, 2023. After that, manufacturers will have to work to get a UKCA mark to sell in the UK.
 
The United States is going through its own regulatory transition as the U.S. Food and Drug Administration (FDA) harmonizes 21 CFR Part 820 with the International Organization for Standardization’s ISO 13485. The resulting Quality Management System Regulation (QMSR) hasn’t been finalized yet, but the FDA’s goal is to make compliance simpler for companies that sell in the U.S. and abroad.

2. Artificial Intelligence in SaMD

We’ve already mentioned SaMD, but the use of artificial intelligence (AI), particularly machine learning (ML), is becoming more common. The FDA has approved several AI-based SaMD, though they’re intended to help, not replace, the physician. In one case, using SaMD improved the detection of cancer by 7%.
 
The technology is ahead of the regulations in this area. While the FDA has an action plan for AI/ML-based SaMD, there are no specific regulations that pertain to this category. Last year the European Commission proposed the Artificial Intelligence Act to regulate AI, but this has a much wider scope than SaMD or even medical devices in general. For now, there are no concrete regulations for how medical device companies can use AI in their devices.

3. Software Bill of Materials (SBOM)

Even when medical devices don’t use AI/ML, an increasing number use software. This leads to concerns about cybersecurity and the dangers posed by someone hacking into a medical device. Regulatory requirements for a software bill of materials (SBOM) can improve the security of a device. This idea isn’t new, but it recently took one step closer to becoming a reality.
 
The U.S. House of Representatives recently passed a bill that would require medical device manufacturers to have an SBOM in their device labelling, which will contain a list of all the software components of a device. This information would have to be shared with the FDA, and the agency can make regulatory decisions based on the robustness of the company’s cybersecurity efforts.

4. Supply Chain Backup

The COVID-19 pandemic has exposed vulnerabilities in the medical device supply chain, and the FDA is determined to prevent similar shortages in the future. The FDA’s Resilient Supply Chain Program (RSCP) is meant to “strengthen public health supply chains by proactively monitoring, assessing, and communicating risks and vulnerabilities to prevent shortages of medical devices.” The agency is concerned with the industry as a whole, but individual companies should also take steps to ensure their survival in case of shortages.
 
One way to do this is to decrease dependence on any single supplier. During the pandemic, certain parts of the world were cut off. So too were any exports from those areas that medical device companies depended on. By having more suppliers in different geographic areas, medical device manufacturers can ensure that they have backups to turn to if similar problems happen in the future.

Conclusion

Regulations may take a long time to develop, but they can still be hard to adapt to when the time comes. The key to keeping up with those regulations and embracing technologies such as AI/ML is digitizing your processes.
 
Finding and qualifying new suppliers and ensuring a consistent bill of materials is much easier on an electronic system. An electronic quality management system keeps track of all the procedures that regulators require and will want to see during an inspection. The sooner medical device manufacturers get on connected, digital systems, the sooner they can begin making data-driven decisions that will prepare them for the future no matter what happens.
 

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Matt Lowe provides a unified vision for the marketing and product teams. He brings a unique understanding of both product and customer knowledge to develop MasterControl’s go-to-market strategies and messaging. Lowe is a medical device expert with experience in product development and product management at Ortho Development Corp. and Bard Access Systems, a subsidiary of BD. Lowe has successfully launched more than a dozen medical devices. He has five patents issued and one pending. His regulatory experience includes writing a 510(k) that was cleared by the FDA and managing a multi-site, multi-year postmarket clinical study for orthopedic devices.
 
Since joining MasterControl in 2006, he has held several executive roles in product, engineering, strategy, sales, and marketing. Lowe has a bachelor's degree in mechanical engineering from the University of Utah and an MBA from Indiana University.