2024 Medical Device Industry Trends

The medical device industry had a busy year, packed with new guidance documents from regulators, supply chain issues, and trying to hire and retain skilled employees. This year, medical device companies need to be ready to implement that guidance, take measures to avoid supply chain issues in the future, and seek out employees skilled in artificial intelligence (AI) and cybersecurity as technology becomes more complex and integral both to medical device manufacturing and the devices themselves.

Preparing for the future starts with knowing what’s coming. That’s why we’ve grouped together below the regulatory, technology, economic, and therapeutic trends that will affect the medical device industry this year.

1: Regulatory Trends

eSTAR
The U.S. Food and Drug Administration (FDA) has several action plans that revolve around using technology in regulatory processes. The electronic Submission Template And Resource (eSTAR) is one component of that. eSTAR is now the required mode for submitting information for a 510(k). While not required, it can also be used for de novo applications. Some of the benefits of using eSTAR include that it guides users through the process and ensures a complete submission, is highly automated, and has links to resources that submitters might need to reference. ¹  It also comes in a familiar format as an interactive PDF. This guidance and process represent another step by regulators to using more automated, digital processes.

The European Union Medical Device Regulation (EU MDR) continues to be overwhelming for medical device companies. One of the biggest problems is the enormous amount of work required by a relatively small number of notified bodies. One source notes that 23,700 certificates will expire in 2024 and re-certification relies on 38 notified bodies — averaging out to almost 624 cases per notified body. And the average processing time is 18 months. ²

Not surprisingly, trade groups are calling for reform, based on the idea that EU MDR, rather than providing a framework that ensures safety and supports innovation, simply prevents devices from reaching the European market. In an open letter to European Commissioner for Health and Food Safety Stella Kyriakides, the trade groups noted, “The regulatory framework is unpredictable, complex, slow, and costly. The result is that medical technologies … struggle to reach European patients.” ³

The FDA’s proposed rule to incorporate ISO 13485 by reference into 21 CFR Part 820 is still just that — a proposed rule. When it becomes a reality, the Quality System Regulation (QSR) will become the Quality Management System Regulation (QMSR) and medical device companies that already comply with Part 820 and follow ISO 13485 will save time and money thanks to the harmonization . However, we’re still waiting on the FDA to finalize the rule.

One thing the FDA did finalize was cybersecurity guidance. In September 2023, the agency finalized its guidance document “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.” ⁵  In the guidance document, the FDA directly ties cybersecurity to quality and recommends using a secure product development framework (SPDF). This might relate to cybersecurity as it pertains to connected devices, but connected manufacturing and supply chain technologies are presenting their fair share of issues for medical device companies as well.

The near constant regulatory changes make it imperative for medical device companies to adopt systems that let them move quickly without compromising quality and while maintaining compliance. Digitizing quality and manufacturing systems gives organizations this flexibility and let them easily demonstrate quality and compliance during an audit or inspection.

Cybersecurity in medical device development is important, but so are the systems that can expedite the development and manufacturing of those devices. There are two themes in medical device industry technology trends: those pertaining to operations and those that are part of the device. When it comes to operations, medical device supply chain management is increasing in importance as the COVID-19 pandemic dramatically highlighted the drawbacks of just-in-time (JIT) manufacturing. JIT depends on forecasting, and disruption from the pandemic and other factors have shown that when one aspect of the supply chain fails, shortages are inevitable.

JIT and lean manufacturing practices have merit and are meant to reduce waste, but at the risk of running low on or out of inventory. This suggests that a new approach is needed. “Operations leaders should work on improving forecasting, planning of batch sizes, and safety stock management,” PwC industry researchers recommend. “Advanced modeling tools can help evaluate the potential effects of stockouts and other disruptions. In short, to become more resilient, medtech supply chains may have to adopt a ‘just in case’ inventory model over the ‘just in time’ model.” ⁶ Stockpiling and having backup suppliers is helpful, but insufficient.

As previously mentioned, finding and retaining employees in the medical device industry is proving to be a challenge. Finding, onboarding, and satisfying employees is an expensive endeavor— especially when candidates need specialized skills. Medical devices increasingly involve more connected, more complicated technology. That means if you want to use AI, you may need to hire data scientists. To meet quality regulations in connected devices, you need to hire cybersecurity experts. One surefire way to make this more complicated for yourself is to look for an elusive candidate that has these skillsets and is a medical device industry veteran. A more economical approach is to invest in training to bring new employees up to speed on the industry.

When it comes to employees with such in-demand skills, medical device companies can lose out to tech companies that typically offer higher pay. While it’s important to offer competitive pay, there are other ways to make a medical device career appealing that involve little to no cost. These include flexible work options where feasible, mapping out a clear career path, and emphasizing the important nature of the work. They can also provide digital tools that are similar to what employees use in their everyday lives to make their jobs easier.

A key place where medical device companies can do this is on the manufacturing floor. As younger generations enter the workforce, they expect that digital technologies will permeate work as much as they do their personal lives. Imagine their disappointment if they show up to manufacture cutting-edge medical devices and are then handed a piece of paper and pen for the device history record. Electronic device history records (eDHRs) aren’t new, but they are becoming more intuitive and easier to configure. A wise investment in an eDHR system has multiple financial benefits. It helps companies keep employees, which avoids the expense of hiring and onboarding new ones. It also lets you use review by exception to get products out the door faster, so you realize revenue sooner and reduce scrap through greater visibility into manufacturing.

Recent research from MasterControl shows that the digitizing trend is catching on in the life sciences. Of the 152 respondents surveyed, 65% are striving to increase digitization in manufacturing and 55% have a formal digital transformation plan in place. The motive for digitizing was largely because it’s a competitive advantage, letting companies get to market and see ROI sooner.