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2024 Medical Device Industry Trends

Discover the Trends Shaping Quality and Manufacturing

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. 1.
    "Electronic Submission Template for Medical Device 510(k) Submissions,” U.S. Food and Drug Administration, Oct. 2, 2023.
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.
EU MDR
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.
  1. 2.
    "EU MDR Challenges Spark Questions,” Katie Hobbins, MD+DI, Sept. 26, 2023.
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.”
  1. 3.
    "Open Letter to Commissioner Kyriakides,” MedTech Europe, Asociatia Furnizorilor de Produse Medicale, et al, Sept. 14, 2023.

The regulatory framework is unpredictable, complex, slow, and costly. The result is that medical technologies … struggle to reach European patients.

–MedTech Europe
ISO 13485 and 21 CFR Part 820 Harmonization

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.

[I]t’s never too early to start. Knowing [harmonization] is coming, I would get on this immediately. The recommendation around the certification process and preparing for that, getting ready for it, and undergoing certification, that way when it does go into effect it’s a nonissue.

–Matt Lowe, Chief Strategy Officer, MasterControl
  1. 4.
    "Diving into FDA’s QMSR Alignment with ISO 13485,” Omar Ford, MD+DI, Sept. 8, 2023.
Cybersecurity
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.”
  1. 5.
    “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” U.S. Food and Drug Administration, Sept. 27, 2023.
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.

2: Technology Trends

Supply Chain Issues

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.”
  1. 6.
    “Supply chain fixes help medtech manage global headwinds,” Chetan Ghatge, Rajiv Rajagopalan, Kevin Lewis, and John Anderson, PwC, Feb. 17, 2023.
Stockpiling and having backup suppliers is helpful, but insufficient.

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.

–PwC
Data, Analytics, and AI

Improved forecasting and planning rely heavily on data and analytics. While it’s impossible to predict every disruption, using technology to map the interconnectedness of the supply chain helps companies track how disruption can affect them. Using AI can tell you quickly how best to react to disruption to recover and keep production up. However, AI is only as useful as the data it’s trained on. So, if your data is still mostly trapped on paper documents or individual computers, it’s time to switch to a connected system that brings all your data together and provides analytics to help you make sense of it.

Beyond connecting your data, digital tools can also help offset labor shortages that are plaguing the industry. “Automated imaging systems for quality checks or orthopedic tools and implants as well as integrated vision and assembly systems,” are examples of solutions that can help.
  1. 7.
    “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” U.S. Food and Drug Administration, Sept. 27, 2023.
It’s important to note that the best solutions work with humans, rather than replacing them. When used this way, advanced technologies can go a long way to alleviating the problems in operations. They’re also being incorporated into medical devices.

Software as a medical device (SaMD), AI used in medical devices, and AI in SaMD all present opportunities but also complications. Not least of which is trying to distinguish between the three and determining how to compliantly develop them. The possibilities of these technologies are exciting, but as with other regulated products, the need for control here is essential. Since AI is by definition changeable, how can manufacturers control it? The FDA, Health Canada, and the Medicines and Healthcare products Regulatory Agency (MHRA) offer these five guiding principles:

  1. Focused and Bounded
  2. Risk Based
  3. Evidence Based
  4. Transparent
  5. Total Product Life Cycle (TPLC) Perspective
    1. 8.
      “Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles,” U.S. Food and Drug Administration, Oct. 24, 2023.

3: Economic Trends

Many industries find themselves needing to do more with less. While investment in medtech greatly increased during 2021, investment has since decreased. This implies that medtech enjoyed profitability due to the pandemic and, now that things are relatively normalized, that profitability is waning. In fact, medtech equity capital in the U.S. and Europe decreased from $29.4 million in 2021 to $12.6 million in 2022 — a decrease of roughly 57%.
  1. 9.
    “Pulse of the Industry medical technology report 2023,” Ernst & Young, 2023.
That’s an unpleasant trend, but not one that medtech companies can’t overcome. The key is to focus resources on areas that can help a medtech manufacturer increase revenue and decrease cost.
57% Reduction in medtech equity ncapital in the U.S. and Europe from 2021 to 2022.
Hiring and Retaining Employees

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.

Digitizing Manufacturing

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.

Sustainability
Speaking of reducing scrap, going green and embracing sustainability is gaining traction in the medical device industry. For original equipment manufacturers (OEMs), reducing scrap makes financial sense and is more sustainable. Some companies are entirely built upon the idea of reprocessing medical devices, making the term single-use device (SUD) a bit of a misnomer. In the arger health care ecosystem, reprocessing makes financial and environmental sense. In 2021, U.S. hospital and surgical centers saved more than $412 million through reprocessing.
  1. 10.
    “Sustainable Technologies: Reprocessing Medical Devices To Reduce Healthcare’s Carbon Footprint And Drive Cost Savings,” Cardinal Health, Med Device Online, May 10, 2023.

4: Therapeutic

Devices for Opioid Use Disorder (OUD)
In 2018, the FDA launched an innovation challenge for medical devices to help combat the opioid crisis and originally selected eight participants for the challenge. Six years later, OUD continues to ruin and claim hundreds of thousands of lives. Data from the Centers for Disease Control and Prevention (CDC) showed that in 2022 there were 109,680 deaths as a result of the opiod crisis.
  1. 11.
    “U.S. drug overdose deaths hit a record in 2022 as some states see a big surge,” Brian Mann, NPR, May 18, 2023.
The medical device industry is in a position to treat those suffering from OUD. The devices that the FDA selected in its innovation challenge range from monitoring to pill dispensing to pain therapy. The agency released draft guidance, “Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder,” to help with the unique challenges of a clinical trial for a device to treat OUD.
  1. 12.
    "Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder," U.S. Food and Drug Administration, July 2023.
109,680 people died in 2022 due to the fentanyl crisis
There’s more than one way to combat OUD. Medical device companies are focusing on alternative ways to relieve pain, thereby removing the means by which some people initially come into contact with opioids. One example of this is a spinal cord stimulator that interrupts the pain signals the body sends to the brain. The pain management devices market is set to grow from $4.4 billion in 2022 to $9.4 billion by 2032 due to an aging population and increasing awareness of pain management.
  1. 13.
    “Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder,” U.S. Food and Drug Administration, July 2023.
Biowearables
Other needs focus more on an individual’s overall health. Wearables are increasing in popularity as just about everyone tracks at least one aspect of their health with a device and an app. Taking things a step further, biowearables give a more detailed look into the body. This can involve monitoring glucose, ketones, lactate, etc. “With biowearables, direct data from our bodies will allow us to unlock even more personalized insights to inform how we can be our healthiest,” explained Marc Taub, divisional vice president of technical operations for Abbott’s Diabetes Care business.
  1. 14.
    “3 Ways Biowearables Will be Advanced Health Trackers,” Abbott, April 26, 2023.
This blurs the line between patient and consumer as some individuals choose to invest in such technologies.

 

With biowearables, direct data from our bodies will allow us to unlock even more personalized insights to inform how we can be our healthiest.

–Marc Taub, Divisional Vice President of Technical Operations, Diabetes Care, Abbott
Internet of Medical Things (IoMT)

These technologies are a critical component of the IoMT. IoMT has the potential to reduce health care costs and provide more personalised care. As devices collect data about a patient’s health, that information can be accessed on an app and/or shared with a health care provider. The larger amount of data gives providers a more holistic view of a patient’s health and remote monitoring of patients reduces the burden of traveling to a doctor’s office or hospital. Of course, that same connectivity brings the cybersecurity challenges mentioned above and further emphasizes the importance of hiring cybersecurity experts.

Conclusion

The medical device industry has slowed down a bit in terms of growth, but not in terms of opportunity. Even though investments have gone down, medical device companies can still find ways to take advantage of the trends affecting the industry this year. Preparing for the FDA ISO 13485 harmonization should be top of mind for regulatory professionals in this industry, as should regulations pertaining to the incorporation of AI into medical devices. Executives can prepare their companies for the future by protecting their supply chains and taking advantage of digital systems to improve manufacturing. Entering new markets is risky, but it’s a prime opportunity to gain a foothold and make a positive impact on health care, the environment, and patients’ lives.

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