Any manufacturing business faces a litany of challenges, ranging from supply chain issues to working with vendors and distributing the final product. However, the unique set of challenges in medical device manufacturing go beyond those general issues and into the realm of regulations and compliance, the rising costs of healthcare, and advanced cybersecurity concerns.

At Pathway Medtech, a medical device manufacturing and development company in San Diego, we’re well aware of these challenges, and we know how to overcome them. Here are the top four!

1) Maintaining Compliance During All The Major Steps Involved in The Manufacturing of A Medical Device

The number one issue that overshadows all other challenges in medical device manufacturing is the intricate web of regulatory requirements facing the industry. Locally, nationally, and internationally, medical devices must maintain compliance with a variety of rules and regulations that govern different aspects of the process.

In particular, manufacturers need to be aware of and abide by the ISO standards for medical devices, which are standards set forth by the non-governmental International Organization for Standardization (ISO). 

In the United States, medical device development is guided by ISO 13485 and ISO 14971:

ISO 13485 – This covers the quality management systems for design and manufacturing, defining the processes and procedures (such as design controls that demonstrate a product is safe and fulfills its intended purpose) needed to bring a product to market.

ISO 14971 – This deals with risk management methodologies, helping manufacturers identify hazards, estimate and evaluate associated risks, and monitor the effectiveness of the controls that are put in place.

2) Dealing With Rising Healthcare Costs

One of the biggest political and economic issues in the United States is the soaring cost of healthcare. A huge array of factors contribute to this issue, with expensive medical devices being just one of them. However, as a very visible factor in rising costs, device manufacturers are facing pressure to reduce costs for healthcare providers and patients. New products must lower the overall cost of treatment.

The problem that manufacturers face is that their own production costs cannot simply be lowered. Though there might be an inclination to simply produce cheaper products — such as ones that are disposable rather than long-lasting — the costs and risks associated with that decision could ultimately exceed whatever short-term savings there might be.

One way to save costs is to invest in 3D printing, which can save time, money, and energy in comparison to traditional manufacturing methods.

3) Keeping Data and Devices Secure

Cybersecurity is a key concern for every industry, but in the healthcare field — where the most personal of patient data needs to be kept safe — it is absolutely vital. A single breach can not only cost time and money, but also lead to massive legal repercussions.

As more and more medical devices become digital and connect to the internet, implementing top-of-the-line cybersecurity in the finished product is just as important as securing the manufacturing pipeline itself. This is the case during all of the major steps involved in the manufacturing of a medical device.

If a device is connected to the internet, it should be hosted on separate networks from other devices to mitigate risk of hackers gaining further access to unauthorized data should a breach occur. What’s more, every cybersecurity best practice needs to be implemented in order to maintain patient privacy and protection. This ranges from data encryption and frequent software updates to password authentication requirements and training for employees.

4) Managing A Disrupted Medical Supply Chain

The global COVID-19 pandemic severely disrupted supply chains across the country and the world. That disruption is still a major aspect of medical device manufacturing today. Between delivery delays, rising costs of materials, and a lowered inventory of both vital raw materials and more complex manufactured components, the entire global supply chain was stretched to its limits.

This is especially true in the healthcare industry, which had to deal with the frontline of the pandemic. Healthcare facilities that provide clinical trials were overwhelmed and unable to take part in the process. This caused massive delays for manufacturers, while those manufacturers themselves were dealing with the challenges of a remote workforce and the need to institute new safety protocols at every level of their business.

The best way for medical device manufacturers to negotiate these issues is to stop thinking about just “weathering the storm.” Instead, they must focus on adapting to a changed world. Instead of relying on a single supplier for materials, manufacturers need to diversify their supply chain. Consider distributed sourcing from different parts of the globe, allowing for adaptation to disruptions as they occur. Using robust tracking programming can also help. It can provide up-to-the-minute data on precisely where any disruptions might be occurring as well as maintaining a full inventory of where supplies and products are in the chain at any given moment.

Consult Pathway Medtech’s Expertise

These issues are complex and daunting, but Pathway Medtech is a professional contract medical manufacturing company that knows how to mitigate them. With proven expertise in getting products to market, our multidisciplinary team of experts can bring your invention to life.