Although medical device manufacturing is in high demand, many manufacturers must understand and overcome obstacles for improvement. Pain points such as unclear regulations, lack of innovative technologies, insufficient investment to support early-stage projects, and more prevent public health from seeing the benefit of these life-saving devices.

With the U.S. medical device market being the largest in the world, there is an excellent opportunity for manufacturers to make profits; however, it isn’t always easy to achieve these profits. Industry experts have estimated that by 2026, this market will reach $208 billion. Here are the top six problems in the medical device manufacturing sector and how to overcome them.

    • Regulatory Complications

Navigating the problematic regulatory climate in the medical device industry is one of the most widespread problems. Manufacturers are frequently subjected to uneven regulations with conflicting language and criteria. It’s not always clear whether something must fulfill a certain set of criteria or not.

Setting your standards is the most effective approach to dealing with this disparity. Manufacturers should apply high-quality standards to all devices, no matter what the law requires. ISO 13495, a benchmark for quality management systems for medical devices, offers a reliable basis.

When regulatory disparities occur, it’s usually best to go for the most stringent option. Establishing a regulatory compliance team of experts well-versed in regulations is also a smart idea. Before they’re implemented, any decisions should go through them.

  • High Healthcare Costs

Another of the biggest problems in healthcare is high costs. Approximately 46 million people in the United States cannot obtain high-quality care due to financial constraints. While medical devices aren’t solely responsible, device prices exacerbate this problem.

With the sharp rise in medical costs, device manufacturers are under pressure to create more affordable products. However, this can be tough when production expenses are so high. A potential solution is cheaper disposable items instead of pricier but longer-lasting options. From a customer perspective, this might not make sense. However, it’s important to remember that sterilization can cost around $10 per instrument meaning reusable products aren’t always the most budget-friendly option in the long run.

3D printing can also reduce production healthcare expenses. Since this process builds up material rather than cutting it away, it reduces waste and saves energy costs. Total production costs decrease as a result.

  • Slow, Expensive R&D

Even more so than other businesses, medical device production necessitates constant study and development. Running important clinical trials is often a time-consuming and costly procedure, which delays the time to market and profitability. Embracing technology like robotic process automation (RPA) and the cloud may be a useful way to solve this problem.

Clinical systems may communicate with one another and aggregate data from numerous sources to provide more complete outcomes thanks to cloud-based collaboration solutions. Many of these systems connect more than 20,000 hospitals, allowing manufacturers to test their goods against a large population. The cloud also allows real-time data from all of these sources to be updated in real-time, speeding up the R&D process.

RPA automation enables faster time to value by integrating with these cloud technologies. RPA automates routine activities such as data entry and organization, providing more rapid outcomes while allowing employees to focus on value-add activities. With these technologies, clinical trials will be shorter and more accurate, lowering costs and improving return on investment.

  • Cybersecurity

medical device newsWith the advent of smart factory technologies, manufacturers have unwittingly placed themselves in a position that is more susceptible to hacking. This, coupled with the increase in hacks on healthcare institutions, has resulted in cybersecurity becoming a significant concern for these industries.

When it comes to connected medical gadgets, manufacturers must ensure that they have effective built-in security mechanisms. Encryption and a method for authenticating over-the-air updates are two of the most important aspects. By default, devices should require passwords and need manual entry to connect to other systems.

  • Counterfeits

With the increased demand for medical devices, counterfeits will also become more prevalent as people attempt to take advantage of the trend. These fake products not only hurt revenue for legitimate device manufacturers but can also endanger patients who use them unknowingly.

Medical device producers may combat fakes by adopting a method to authenticate their devices. Blockchain technology might be the perfect location for such a system. Blockchains make it simple to show that a product is genuine by providing a public, immutable list of entries.

Medical Device Manufacturing Evolution

Medical devices are an important business sector. As a result, manufacturers must overcome these impediments to ensure that customers can obtain the tools they require without difficulty. These obstacles may appear daunting at first, but they aren’t insurmountable. You can conquer these problems by following technological implementation and workflow adjustments carefully.

Mr. EJ. Letko is an experienced medical device manufacturer with insights that can help your business overcome some of the common manufacturing challenges in the industry. By understanding these hurdles, you can implement a plan to avoid them and increase production efficiency. If you want more information on overcoming specific manufacturing challenges, reach out to us. We would be happy to share our expertise and help your business grow!

References and Resources