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4 min read

Preventing Medical Device Component Shortages

medical device electronics design

Medical device component shortages are still disrupting production in 2025. 

The FDA recently added hemodialysis bloodlines and other Class II devices to its shortage list, citing supply issues expected to last through the end of the year. For teams under pressure to meet both deadlines and safety standards, the timing couldn’t be worse.

The challenges aren’t easing. Lead times for critical components often stretch several months, and sourcing options are shrinking as demand continues to grow. Even well-prepared manufacturers are feeling the strain as more health care materials require specialized handling and approvals.

Staying ahead means more than reacting to delays. It starts with understanding where the risks are – and putting strategies in place before the shortage hits your production line.

Medical Device Component Shortages: What OEMs Should Know

The big reason why medical device shortages are so rampant is because medical technology changes in a heartbeat. When you combine these changes with an increasing demand for electronic parts, component suppliers can't quite keep up with the pace. 

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:

  • Lengthy lead times for specialized electronic components

  • Supply chain interruptions because of natural disasters, political turmoil, diseases, etc.

  • Dragged-out FDA approval for medical device components

In 2025, the U.S. imposed new tariffs ranging from 32% to 49% on imports from several Southeast Asian countries, including Vietnam and Thailand. These tariffs have disrupted established supply chains, leading to increased costs and prompting OEMs to reassess their sourcing strategies.

If you rely on a single region or factory for sourcing, a sudden disruption – such as a natural disaster, political unrest, or a global health crisis – can bring your supply chain to a halt.

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 Device Component Shortages So Widespread?

You might remember from your high school economics class the basic principle of supply and demand. With continued growth in the medical device sector, there will be high demand for components, often resulting in limitations in the supply chain -- at least in the short-term. Not to mention that technological advances keep on coming down the line, changing the demand for certain components. 

When will the shortage end? Predicting when the shortage will ease is difficult. Demand continues to grow while supply chains struggle to keep pace. 

That said, there are still practical steps you can take. Being proactive about risk can make a meaningful difference as you navigate the ups and downs of the current supply environment.

How to Manage Medical Device Component Shortages

How can your company get ahead of the component shortage and keep production flow moving and customers happy?

Stock Up 

If your cash flow situation allows for it, purchasing your components well in advance can alleviate the strain of a component shortage. They’ll be ready to integrate into devices when you need them. This is especially true for components with long lead times, which can slow device production and profitability if you’re left waiting.

However, buying in advance does have a risk to it, especially when you consider obsolescence management and how a great component for today may be worthless tomorrow. You don’t want to be stuck with a stockroom full of obsolete components.

Forecast

Accurately forecasting your component needs can significantly lower the amount you have to shell out for components. If you scope out what you’ll need months, or even years, in advance, you’re better positioned to stay ahead of medical device component shortages.

Your electronics manufacturing services provider should always communicate potential obsolescence or shortage risks to you.

Build Relationships 

Who do you work with to acquire components? Whether it's a supplier or a contract manufacturer, we encourage you to build a relationship with these entities so they're more than just a partner -- they’re an extension of your business. 

By doing so, you're much more likely to have transparent discussions about the parts that you need and work together on solutions to overcome certain component challenges.

Medical Device Component Shortages FAQ 

Still have questions after reading through the strategies? Here are a few common concerns OEMs and manufacturers face when navigating component shortages.

Q: What qualifies as a “specialized” electronic component in the medical space?

A: Specialized components are those designed for specific functions in regulated devices – like ASICs (application-specific integrated circuits), custom sensors, or HDI PCBs. They often have strict performance, biocompatibility, or durability requirements.

These parts usually come from limited suppliers and require longer lead times due to qualification and regulatory demands. Their complexity makes them harder to replace when shortages arise.

Q: How do I know if my sourcing strategy is too risky?

A: If you rely on a single region, supplier, or just-in-time inventory, your sourcing approach may be vulnerable. Limited visibility into your supply chain or frequent delivery surprises are red flags.

Scrambling for replacements or regularly shifting production schedules due to late parts suggests it’s time to reassess your sourcing strategy.

Q: What tools or methods can improve forecasting accuracy?

A: Forecasting improves with clean usage data, planning software, and regular communication between sourcing, production, and suppliers. ERP systems and rolling forecasts help track demand shifts.

Sharing forecasts early and maintaining open communication with vendors helps both sides stay aligned on availability and lead times.


Mitigating Medical Device Component Shortage Risk

Keeping abreast of potential supply chain interruptions gives your team a better chance of staying on track. The ability to sidestep delays often comes down to preparation: 

  • Clear expectations
  • Strong communication
  • A support network that doesn’t disappear when parts get hard to find

Stability doesn’t happen by accident. It takes consistent planning to stay resilient in the face of medical device component shortages. When you understand your exposure and stay engaged with trusted partners, you’re less likely to get caught off guard.

Struggling With Obsolete Components?

When parts disappear from your supply chain, having the right partner in place can make the difference between a stalled project and a workable solution.

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This article was originally published in January of 2022 and was recently updated to reflect current industry trends.

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