Causes, Costs and Cures for Unplanned Downtime: Insights for Medical Device Manufacturers

Some causes of unplanned downtime are as old as manufacturing itself, while others are very recent. Some of these causes impact highly regulated industries, such as medical device manufacturing, more so than other areas of manufacturing.

Whatever the cause, the damage is considerable. The very nature of manufacturing means that a disruption at any point, large or small, will dramatically affect your entire supply chain.

In this post, we’ll look at the costs and causes of downtime. We will then proceed to lay out effective methods of preventing costly delays by tackling the causes of unplanned downtime.

The Cost

The biggest cost of downtime is measured in lost production time. A loss of production hours cuts into a company’s profitability. Stalled machines and processes also mean operators and other employees can’t work. One study found that 3 percent of manufacturing working days were lost to downtime caused by machine breakdowns.

Not only can lost production affect current orders, but it most certainly could affect future opportunities with both current and future customers. Failure to deliver on time hurts a company’s reputation and puts a crack in the growth plan.

The Cause

While there are a lot of reasons for unplanned downtime, some of the most common include:


Equipment failures

The very machines that make manufacturing possible are also major causes of unplanned downtime. A full 42 percent of unplanned downtime happens because of asset failure. Sometimes the fault lies with the machine itself but far more often it is the result of misuse or poor monitoring and maintenance regimens.


External disruptions

While the Covid-19 pandemic shook up global manufacturing like few other events in history, it still belongs to a larger group of external forces that can break critical links in the supply chain. Wars, economic downturns, natural disasters, changes in legislation, power outages… any of these can temporarily grind production to a halt.



When ransomware infects systems, it captures and holds data hostage until victims pay for its release so work can resume. Even when payment is made, a significant percentage of cybercriminals then request a second ransom and an even larger number never return data access at all. Nearly 80 percent of manufacturers have been targets of a cyberattack. Of these 47 percent resulted in operational downtime.



The manufacture of medical devices takes place under highly sanitized conditions. Devices exposed to contaminants may be rendered unusable. When major decontamination is required, access to critical facilities is restricted until a cleanroom environment can be restored.



Medical device manufacturers are subject to audits and site inspections by regulatory agencies such as the FDA (Food and Drug Administration). Failing an inspection could require shutting down parts of the operation in order to bring them up to standard. At worst, the agency could order an injunction against a manufacturer to stop them from producing or distributing a product. In the most extreme case of “downtime” a company may be barred or its products quarantined.


Lack of agility

An inflexible supply chain is unable to respond quickly to any disruption. Among other things, lack of agility is associated with unclear and ineffective strategies and subpar systems including:

  • Inefficient sourcing and procurement
  • Lack of an adequate ERP system
  • Suboptimal logistics models
  • Inaccurate demand forecasts
  • Inability to scale workforce on short notice
  • Inability to scale demand
  • Lack of disruption escalation processes

The more rigid your supply chain, the slower and less coordinated your reaction, the longer the downtime and the higher your costs.  It is also why having a thorough business continuity plan and process is so critical.

The Cure

When it comes to preventing unplanned downtime to keep your production up as planned, you have three options:


You can implement all precautions and provide oversight yourself.

This requires a huge investment. Not only do you need the right equipment (and ensure that it is all properly used and maintained), you need to find and hire the right people with the right training to implement the right processes and observe the right precautions.


You can outsource parts of your supply chain.

While this gives the illusion of filling in gaps in current expertise or capacity, in truth, it means you are left with a fractured overview of your supply chain. This makes it difficult to assess risks of unplanned downtime that can accrue costs and throw off your entire production schedule.

For example, how do you know that someone else’s machines will be in optimal working order for the duration of your project? (Keep in mind that the majority of manufacturers cannot say for certain when their assets are due for maintenance or upgrades. An astounding 75 percent have only a vague idea of when their equipment will reach end of useful life). Have employees been trained and equipped to maintain a sterile environment to prevent contamination-based downtime?  As for cyberattacks, it only takes carelessness on the part of one employee from one supplier to potentially expose your entire supply chain to cyberthreats


You entrust your supply chain – and downtime prevention – to an end-to-end contract manufacturing partner.

Nothing reflects a stellar record for managing downtime like on-time delivery of compliant, high-quality products. Nothing says preparedness and flexibility like passing nearly a hundred audits per year, all with high ratings. An end-to-end contract manufacturer has all the facilities, processes, people and expertise ready to deliver your product, from design to production to packaging.

This includes downtime-busting assets such as:

  • An agile and resilient integrated supply chain able to respond quickly and effectively to disruptions
  • Multiple ISO 13485 production facilities which can be leveraged as part of continuity plans if external forces render one location unusable
  • Maintenance schedules driven and updated by advanced technologies to ensure all machines are in good working order
  • Employees trained to recognise and avoid potential cyberthreats
  • Digitally backing-up information, plans and systems so that in case a cyberattack does happen, restoration is swift and production can continue.
  • Optimally designed cleanrooms to enable regular cleaning activities without interrupting production
  • Staff trained to observe strict cleanroom protocols thereby reducing the introduction of contaminants
  • Absolute compliance with all laws and regulations from all countries where it operates or serves, so inspections and audits go smoothly
  • Having a robust, multi-faceted business continuity plan

Unplanned downtime is inconvenient and costly. Likewise, preventing unplanned downtime – thereby sticking to a promised schedule and delivering on time – not only saves you money, in the medical device industry it also saves lives. Working with a CM that can reduce downtime tells your customers that they can depend on you, building trust for solid, long-term business relationships.

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About Providence Enterprise

Providence Enterprise is a Hong Kong medical device contract manufacturer of Class I and II medical devices with manufacturing in China & Vietnam. We specialize in electro-mechanical assemblies and high-volume disposables. We are FDA registered and ISO 13485, ISO 14971, ISO 14001, ISO 27001 certified. Our capabilities include fabricating tooling for silicone rubber and injection molded plastics, clean room injection molding, electronics, clean room assembly, and sterilization.