What are the Current Challenges Facing Medical Device Staffing

The medical device industry is undergoing significant transformation due to various factors, including rapid technological advancements, evolving and complex regulatory frameworks, and supply chain disruptions. These challenges not only affect the industry itself but also directly impact medical device staffing, emphasizing the need for specialized expertise.

Funding and instability challenges that impacted other life sciences sectors in 2024 were less prevalent in the medical device sector. As a result of this, investment into marketing and selling devices was huge. Medical device organizations have been able to capitalize on the availability of talent to prepare for successful trading in 2025. The race for quality talent in engineering, regulatory, artificial intelligence and commercial is set to be aggressive throughout 2025.

Read our in-depth guide to gain insight into the challenges that make finding talent in the medical device sector difficult. 

Artificial Intelligence

While artificial intelligence and machine learning have positively impacted several aspects of the industry, they have also created numerous challenges related to medical device staffing.

The AI’s Advancement is Creating a Skills Gap 

The increased use of AI in the industry has created a demand for new skills that few medical care professionals currently have. Here are a few examples of the reasons driving the talent gap: 

• Technological Developments: AI requires a workforce proficient in the latest tools and technologies; however, existing professionals do not have adequate training or expertise to use them properly. For example, this has hampered the European medical device industry as it lacks data scientists and bioengineers who can utilize AI for diagnostics and personalized medicine. 
• Educational Gaps: AI technologies are advancing so fast that educational institutions have struggled to keep up. This has meant that many current qualifications and training are not aligned with the new tech skills needed for medical device jobs.  This results in a workforce that are not equipped to meet modern and future medical technology’s demands. 
• Regulatory Challenges: These new technologies are subject to stringent and complex regulatory requirements that need specialized knowledge. Currently, many professionals in the industry do not have that expertise. This knowledge gap complicates compliance efforts and hinders innovation within medical device companies.
• Competition for Talent: Huge numbers of sectors outside of life sciences are vying for professionals who have exposure to AI technologies, as their use is increasing across all areas. For example, many tech firms can offer high salaries that medical device companies, especially startups, often struggle to compete with.

Reimbursement Codes

Reimbursement codes for medical device products in the USA are vital for medical care providers to secure payment from insurance companies for the products and services they provide to patients. 

Utilized by federal programs like Medicare and Medicaid, as well as several private insurance companies, Current Procedural Terminology (CPT) codes are regarded as the most important coding system for medical device reimbursement. 

Coding, coverage, and payment are the main components of reimbursement, and CPT codes are split into the following three categories: 

1. Category I Codes: These are used for procedures and treatments that meet particular criteria - including FDA approval and proven clinical efficacy. 

2. Category II Codes: Supplement Category I codes to record performance and quality of care.

3. Category III Codes: Temporary codes for emerging technologies designed for data collection and monitoring.

Difficulties Associated with Reimbursement Codes 

Challenges with reimbursement codes for medical device products derive from the intricate and unpredictable nature of medical device reimbursement. Let’s take a look at the issues in more detail. 

Complex Coding Systems 

Medical device diversity is vast. They vary in intricacy, functionality and their application. Compounding this complexity is the need for each device to have a specific coding system to represent its traits and usage accurately. This means that there are multiple coding systems, such as the aforementioned CPT, and the following: 

• HCPCS (Healthcare Common Procedure Coding System): Used for products, supplies, and services. 
• ICD-10-PCS (International Classification of Diseases, 10th Revision, Procedure Coding System): Codes used for diagnoses and symptoms. 

Code Assignment Delays 

Delays in medical device reimbursement cause problems for manufacturers and medical care providers, regularly obstructing patient access to innovative treatments. These examples illustrate how: 

• CPT Code Assignment: The assignment of CPT has several requirements. It needs endorsement via the Coding and Reimbursement Committee, surveys from a minimum of 30 treating physicians, and roughly 150 to 300 physicians with adequate experience with the device. This process can last up to two years. 
• HCPCS Code Assignment: These codes can only be applied for the following three months of market experience. This means that new devices must be marketed and sold without the appropriate billing code, resulting in the possibility of uncertain payment. 

Coverage Uncertainty

Coverage uncertainty can be a significant barrier to medical device reimbursement. It impacts whether a payer will cover the cost of a device and under what conditions. This can result from a lack of evidence relating to the device’s efficacy, safety, or cost-effectiveness. 

Consequently, a lack of clarity means payers may delay or deny reimbursement, affecting market access, patient adoption, and manufacturer revenue. It impacts both manufacturers and medical care providers: 

How it affects manufacturers

• Investment Risk: Manufacturers experience difficulties forecasting returns on investment with new technologies. This type of unpredictability can prevent funding and thwart innovation. 
• Market Entry Delays: Securing appropriate codes and demonstrating value with real-world data is often a lengthy and complex process, which can delay market entry.
• Global Challenges: Diverse regulatory requirements and inconsistent reimbursement rates across countries convolute global market penetration. 

How it affects medical care providers

• Access to Technology: Reimbursement uncertainty can restrict providers' ability to access and offer specific technologies to patients.
• Financial Risk: Providers may be reluctant to adopt new devices when reimbursement uncertainty raises concerns about adequate compensation.

Medical Device Supply Chains 

Medical device companies need experts who specialize in ensuring that medical device supply chains are strong enough to withstand disruptive circumstances. Weak supply chains can be detrimental in a number of ways. 

Most critically, it can have severe consequences for patient care. Also, failing to optimize supply chains can be expensive. A Gartner study found that obtaining a cost-effective supply chain is a challenge, with the cost to serve averaging 37.3% of the cost of patient care. 

Disruptions to Supply Chains  

In recent years, the medical device industry has experienced numerous disruptions that have threatened the production and distribution of medical devices, for example:

• Semiconductor Shortages: The global semiconductor chip shortage has drastically hindered medical device production. According to a Deloitte study, more than half of manufacturers depend on one source for their semiconductors. 
• Raw Materials: Essential alloys and metals, such as titanium and cobalt-chrome, are needed for many products. Geopolitical tensions, energy concerns, health implications, and other factors obstruct a consistent supply of raw materials to the medical device industry. 
• Sterilization Constraints: Sterilization is key to bringing products to market. Medical device companies rely on ethylene oxide (EtO) as their main method for sterilization. In the U.S., EtO sterilizes 50% (over 20 billion units) of products. However, because EtO sterilization is linked to adverse health effects, recent lawsuits have slowed medical device production.

Localization and Nearshoring 

To strengthen supply chains and mitigate risks associated with a volatile global market, many companies are localizing production. This transition has meant there’s a demand for professionals who know local supply chains, are familiar with regulatory requirements, and understand the medical device market. There are several benefits to hiring professionals with expertise in nearshoring, such as: 

• Simplified Supply Chains: Companies that nearshore can expect lower logistics costs and enhanced collaboration. 
• Resilience: A localized supply chain, supported by local knowledge, is better equipped to manage disruptions and meet medical device market demands. 
• Time Zone Advantages: Partnering with those in similar time zones improves communication. 

Final Say: Challenges Facing Medical Device Staffing

The medical device industry is grappling with significant challenges, from managing regulatory complexities to addressing cybersecurity risks and supply chain disruptions. These issues are reshaping staffing needs, with a growing demand for specialized talent across various sectors. With the rapid advancements in AI, cybersecurity, and compliance requirements, companies must adapt quickly to remain competitive and ensure patient safety.

In such a fast-evolving environment, securing the right talent is crucial for overcoming these challenges effectively. As the industry continues to transform, businesses must prioritize strategic hiring to stay ahead of the curve and drive innovation in medical technology.

Do you have the Talent to Overcome these Challenges?

At Barrington James, we know that to thrive in the medical device sector, you need access to quality talent who possess the skills that will future-proof your business. We have an extensive global network of professionals with vital experience and knowledge in areas from AI to cybersecurity to regulations. With our expertise and personal approach, we ensure you can continue to make an impact in your markets.

Discover how we can support your staffing needs today. Visit our medical device page or contact us today to connect with one of our experts.