The top manufacturers are producing devices that improve lives and create better patient outcomes such as neurotransmitters, cochlear implants and pacemakers, along with medical devices that help diagnose patients such as X-ray machines, MRI’s, and Cat-scans. From simple to complex, all of these products are regulated by strict government guidelines to ensure patient safety.
Staffing challenges in medical device manufacturing can range from finding the right workers to meeting high demand without increasing costs. Learn how to mitigate some of the challenges so you can retain productivity and efficiency.
Challenges for Medical Device Manufacturers
Because medical device manufacturing is a delicate, large-scale process, this industry can face more challenges than others. Below we’ve outlined four major challenges for medical device manufacturers.
High Cost of Production
Medical device production involves many experts from start to finish. By creating a solid foundation from the outset and making clear and concise requirement specifications, medical device manufacturers may be able to reduce the costs of production as well as expedite to-market times.
Following lean manufacturing principles can help reduce costs during manufacturing in addition to clear and concise specifications at the outset. Managing and working toward demand and forecasting correctly keeps excess time and expenses down.
Some ways medical device manufacturers can reduce their production costs include:
- Optimize supply chain management
- Negotiate with material suppliers
- Invest in your employees to boost productivity
- Automate some manual processes
- Identify opportunities to reduce damage and eliminate waste
Medical devices are subject to regulatory scrutiny by the U.S. Food and Drug Administration’s (FDA’s) Center for Medical Devices and Radiological Health (CDRH). Depending on the device classification, along with other factors, federal regulations define requirements that must be fulfilled for CDRH to approve or clear devices sold in the United States.
If your medical device is distributed internationally, there are even more regulatory barriers to entry.
Regulatory compliance and quality are two areas of medical device manufacturing that would benefit from a “buy/borrow/build” recruitment strategy. The size of your company, the cycle speed with which you take products to market, and the existing domain expertise that you have in these critical areas will determine whether it makes sense to build a department, utilize fractional talent solutions including contractors and consultants or engage in a specialized search for an expert who can lead this function for the company. TERRA helps clients determine the right strategy for their unique business situation. To discuss the best strategy for you, contact TERRA Staffing Group today.
Tight Skilled Labor Market
Looking beyond a turbulent 2020, employers face challenges when seeking skilled labor. According to McKinsey, 14% of the workforce needs to be partially reskilled and as much as 40% needs to be entirely reskilled to meet current labor market demands.
Finding, hiring and training skilled labor for medical device manufacturing is a major challenge. Between a lack of skilled workers and a constantly evolving set of goals and requirements, choosing the right workforce is an ongoing challenge.
Outsourcing hiring and training to professionals skilled in finding workers in manufacturing, design, management and security can help reduce the time and expense of hiring skilled workers.
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Technology and Cybersecurity
As more medical devices connect to networks or are otherwise entwined in the Internet of Things, there comes an increased threat of cybersecurity. According to MedTechIntelligence, software issues have replaced design issues as the main cause of FDA medical device recalls since around 2014. An analysis of devices released between 2011 and 2015 found that 627 devices were recalled due to software, affecting 1.4 million units.
According to IBM, the average cost of a data breach in 2020 was $3.86 million. That amount increases dramatically if a manufacturer is working without skilled cybersecurity professionals.
Step one to solving technology barriers that cause recalls is to employ skilled information technology and cybersecurity professionals, especially if you are working with a network-connected device.
Beyond using experts, security should be a part of medical manufacturing from the start, not an afterthought. The entire process of designing your network-connected device should be informed with the concept of cybersecurity, reducing the need for recalls due to risks.
Connect with TERRA Staffing
TERRA Staffing is an industry leader in manufacturing, helping reduce friction when hiring skilled workers for medical device manufacturing. From finding appropriate candidates to enticing them to your operation, TERRA Staffing can help.
If you’re still struggling with human resources during the ongoing challenges of the COVID-19 pandemic, consider our webinar, “HR in a Post-Pandemic World.”
Connect with TERRA staffing and request more information.