Medical Device Supply Chain Guide for Electronic PCBs & Parts

Shortages in the Medical Device Supply Chain

Medical device component shortages are rampant. And it's not just one type of component that's experiencing high demand – it's everything from capacitors to resistors to integrated circuits. To further complicate matters, manufacturers might face any or all of the following issues:

• Lengthy lead times for specialized components
• Unexpected supply chain interruptions due to natural disasters, politics, etc.
• Dragged-out FDA approval for new medical device parts

Even though electronics manufacturing providers want to provide fast and easy service for medical electronics components, sometimes extenuating circumstances prolong the time to market in product development, which can irk end customers.

Why Are Medical Equipment Components So Scarce?

The design team knows it has a great idea that can help people, the bosses know the industry needs it, and you know nothing will go according to timelines.

Sound familiar? Delays in medical device manufacturing are irritating for all departments. Instead of throwing your hands up in defeat, start to learn why these delays happen. This is the first step to developing proactive workarounds.

Current causes of PCB and component supply strain include:

• Constant growth: There’s simply huge demand for components, with no end in sight.
• New tech: Medical devices evolve rapidly, which means the demand for certain components can too.
• Natural & man-made disasters: Whether it’s a monsoon or a geopolitical flare-up, it seems there’s always something hampering the global supply chain. 
• Tariffs: Trade restrictions involving the U.S. have limited access to critical components.

When will the shortage end? We’re probably looking in terms of years, not months. The demand for new-and-improved electronics for medical applications is never-ending, so predicting when supply will catch is a bit of a guessing game. 

That doesn’t mean there’s nothing you can do about it. Taking the necessary precautions to weather the storm can go a long way in traversing the shortage landscape.

Obsolescence Management in Health Care

Most medical and electronic printed circuit boards are produced overseas. This leads to extended shipping times, communication challenges, and potential quality issues during transit. 

When parts are defective, or a wrong component is shipped, delays can stretch out months – sometimes, many of them.

In a post-COVID world, we’re all still witnessing staffing gaps, parts shortages, and shipping backlogs. Nearly every industry saw massive delays and increased shipping rates in overseas manufacturing. 

In particular, for the medical industry, the global component shortage has delayed some orders 8-10 months, with legal and medical issues compounding, and medical device OEMs have had to face serious concerns over device obsolescence.   

The shortages and bottlenecks in the health care supply chain have made obsolescence risk mitigation much more difficult. Some medical device manufacturers may need to plan several years ahead to ensure their equipment does not become unserviceable. 

While obsolesces in medical devices is a major problem for medical professionals and healthcare organizations, the patients are those who suffer the most.

But the good news is that coping with these growing difficulties is no longer complex, thanks to domestic electronics contract manufacturers. While ECMs can’t solve these problems overnight, finding a reputable ECM with experience in the medical industry can protect your patients and reduce the risk of obsolescence.

Managing Obsolescence in Medical Product Life Cycle

Medical devices need to be reliable and up-to-date to ensure the safety of the patient. With that said, any electronic device will move through the life cycle and ultimately need parts replaced. If the part happens to be obsolete, that’s when the “fun” starts. Obsolescence management is the way to be proactive and reduce the occurrence of these issues.

The medical equipment life cycle is delicate and complicated. If we had to shave it down to four facts to remember, they’d look like this:

1. Component suppliers will drop a product line in a heartbeat.
2. Regulations make obsolescence management time-consuming.
3. Careful planning in the design stage can patch up obsolescence issues.
4. Your contract manufacturer should help you navigate component obsolescence.

SHORTAGES CAN CAUSE SERIOUS HEADACHES AND FINANCIAL LOSSES

When a part goes obsolete, a component supplier may end production of it before you can properly react. This can lead to major disruptions in your ability to produce life-saving equipment.

Situations like COVID-19 only increase the frequency of supply chain snags. During the crisis, some component vendors shut down, not realizing the havoc they were causing to OEMs. Just one missing component can prevent the shipping of a product. 

In highly regulated industries, some components are already hard to come by, making the slightest disruption a challenge:

A customer of ours once had an application that required ceramic capacitors. The component supplier suddenly decided to stop making the part, even though the customer had in-progress orders from multiple major auto manufacturers. The supplier’s response? “Sorry. Too bad.”

Even just a few weeks’ delay in sourcing a medical device component can leave your electronics contract manufacturer unable to move forward.

REPLACING OBSOLETE PARTS CAN BE TOUGH AND TIME-CONSUMING DUE TO REGULATIONS

Just like with aerospace manufacturing, medical device manufacturing requires cutting past a lot of red tape to comply with current laws. While it might be OK to absent-mindedly switch out parts in the rest of the electronics industry, the same is not always true for medical devices. You have to wait for the whole regulatory process to play out every time you make a change to the guts of your device.

If you have an issue with a component on your medical device PCB that the FDA signed off on, you can’t replace it without getting it cleared. Now you have a $10,000 piece of medical equipment that’s waiting for months on a $1 part.

PLAN CAREFULLY DURING THE DESIGN STAGE

Situations where you have to stop everything due to a component shortage, are deeply frustrating – but some of them are avoidable. There are a few useful approaches that can minimize such risks:

• Be as vague as possible on specifications. This makes it easier for the ECM to find a suitable alternative when necessary.
• Use software to follow parts through their life cycle. Third-party component obsolescence software like SiliconExpert can help you follow your components throughout their life cycle so you can identify when problems are likely to arise. You can spot problems early on and proactively resubmit components for FDA approval.
• Make a large last-time buy. If you know obsolescence could really harm your product line, be ready for potential last-time buys to minimize downtime. Third-party software and the watchful eye of a good PCB manufacturing partner can help you do this.

THE RIGHT ECM VENDOR WILL HELP YOU MITIGATE RISKS

Work with an electronics manufacturing contractor that has experience in medical equipment life cycle management, and the tools to do it. Early on in the medical device electronics design process, your ECM can help you identify opportunities for proactive obsolescence management.

Your ECM can take the lead on managing software like SiliconExpert to track the parts you need for your product. Your partner should also be well-practiced in identifying and sourcing alternative parts that are compatible with your design.

And of course, your PCB supplier should absolutely have ISO 13485 certification.

Compliance for Medical Devices

It probably doesn’t shock you that the medical industry is one of the most tightly regulated in the world. Below are the standards and agencies of which you’ll want at least a passing knowledge.

ISO 9001 vs. 13485 Certification

You may be asking, if the issue is quality, isn’t ISO 9001 – and its emphasis on continuous improvement and customer satisfaction – enough? Not in the medical world.

ISO 13485 is based on ISO 9001 principles, but is a standalone certification specifically designed for the medical device industry. ISO 13485:2016 (the full name of the latest version) adds critical requirements around devices, documentation, and safety.

ISO 13485 focuses on covering your rear end. More specifically, the emphasis is on managing risk – on foreseeing and fixing problems before they occur:

• Record keeping
• Device history records
• Regulatory requirements for documentation and records
• Product and process verification procedures are carried out on protocols specific to medical devices
• A contractor’s entire supply chain is re-evaluated
• Auditing occurs annually

In other words, ISO 13485 represents an exhaustive effort to make sure each component meets rigorous medical device manufacturing standards.

In many cases, the electronics contract manufacturer is ISO 13485-certified, but the OEM ordering that PCB (printed circuit board) assembly isn't. OEMs are strictly regulated by FDA medical device regulatory requirements and have to comply with Current Good Manufacturing Practices (CGMP), which focuses more on the finished product than the guts within.

The spirit of those same guidelines is baked into ISO 13485, so certified manufacturers have shown to auditors that they’ve applied CGMP, too. That’s yet another valuable layer of support behind a medical device manufacturer!

ISO 13485 Certification: A Critical Extra Layer

IPC (another standards org you're probably familiar with) lists medical equipment as Class 3 electronics. Unsurprisingly, this is because failure of a circuit board or component could put lives at risk.

A manufacturer doesn’t have to be an ISO 13485-certified company to meet medical device manufacturing regulations. And it doesn’t have to be certified to make and sell medical device components or the finished devices.

However, a medical device manufacturing certification tells everyone – regulators and customers included – that your electronics underwent an objective evaluation by a third party and are proven to be safe.

An electronics manufacturer can be part of a long supply chain. With a specific ISO certification for medical devices on its side, a contractor can ensure its end of the deal meets the highest standards.

Medical Device Contract Manufacturing Without ISO 13485

Such rigor is not mandatory – you can legally release a product to the market without using a certified supplier. It’s up to you whether to add this layer of quality control.

So, what could go wrong if this “unnecessary” certification isn’t accomplished? What if a component manufacturer doesn’t have ISO 13485 certification and something goes amiss when the device is used in the emergency room?

Chances are the FDA will investigate the OEM. And that means the OEM will need lots of records to verify compliance with regulated processes. If the medical device contract manufacturer can say with confidence that all the necessary records are available, any OEM will sleep easier.

OEMs want proof of a contractor’s manufacturing processes as a way to help validate their final products. A PCB manufacturer’s records must meet strict medical requirements.

Some contractors go a step further in the validation process. They audit their critical component suppliers annually to make sure they meet the contractor’s testing and inspection standards. Working with such a contract manufacturer is a great way to reinforce the safety chain without lifting a finger.

IPC Classes

IPC is a global trade organization that developed and manages a set of standards any sourcing team should get familiar with.

The IPC class system outlines acceptability levels for each of its three tiers. Higher classes – like medical equipment – receive more scrutiny from a quality standpoint. 

Anyone dealing with PCB procurement in health care should have at least a working knowledge of the IPC class system – it directly affects cost, quality expectations, and supplier selection.

PFAS Restrictions

PFAS (perfluoroalkyl and polyfluoroalkyl substances), also not-so-lovingly called “forever chemicals,” are an emerging issue in medical electronics. They’re popular for their chemical resistance, high temperature tolerance, and nonstick properties.

The problem is, these useful substances are a major environmental and health risk. As of May 2025, the Environmental Protection Agency’s TSCA PFAS Reporting Rule requires detailed disclosure on their use. In other words, medical device manufacturers must prove the absence or traceability of PFAS in their parts.

Your procurement team will need to vet PCB and component vendors more carefully. One with design expertise is beneficial, as PFAS-based materials aren’t easy to replace 1:1.