Every industry has its challenges, but few are faced with the unique difficulties that medical device manufacturers face. Not only is the industry a competitive one, but medical device manufacturers also affect their customers’ lives to a degree not seen in other industries. Thus, medical device manufacturers must contend with both their competitors as well as industry regulations, a combination that has led to some very unique challenges.
In this article, we’ll explore three of the most pressing challenges for medical device manufacturers and how to solve them.
When a component doesn’t perform as expected, most other manufacturers simply switch to another supplier or begin using a different material. This is not so easy in the medical device manufacturing world.
Before you can begin producing a medical device, the device’s design needs regulatory approval, which includes its individual components. Thus, switching suppliers presents some major hurdles. Do they have the correct tooling to produce the requisite component? How quickly can they be trained in manufacturing the component? Will they meet regulators’ standards in an audit?
Because of this, selecting a high-quality supplier the first time is a key challenge for medical device manufacturers. These relationships are very sticky, so a manufacturer needs to be confident in their supplier’s capabilities and reliability.
A globalized supply chain drives significant cost-savings; so much so, it’s almost more difficult today for a manufacturer to build their entire supply chain within a single region.
While the lower costs of a global supply chain are too attractive to pass on, it does present another challenge for medical device manufacturers. Because medical device manufacturing has such strict supply chain requirements, some manufacturers can find themselves in serious trouble if one of their suppliers is located in a region facing a disaster.
There are numerous manufacturers, for instance, who source materials from China — what happens when a major pandemic, earthquake, or political instability disrupts shipping?
Many medical device manufacturers don’t put much thought into disaster mitigation. But when something does go wrong, these manufacturers are caught flat-footed. In order to address this challenge, medical device manufacturers need a comprehensive, regularly updated disaster recovery plan.
This should identify key stakeholders, potential alternative suppliers, possible responses to different disasters and other factors pertinent to disaster recovery. Just thinking about this early and regularly already puts you ahead of many other manufacturers.
In most industries, a customer can always return a defective product or a product that broke early in its lifespan. In the medical device industry, this is rarely possible. End-users rely on medical devices to support their health, and are often in dire need of a working product. Sometimes, these devices are embedded within an end-user, making their return obviously impossible.
Since medical devices can’t be returned and since they play such a crucial role in the health of their end-users, medical device manufacturers need to produce high-quality products every time. If something goes wrong, manufacturers will be obliged to shut down their operations until they’ve pinpointed the exact problem.
In order to address this, medical device manufacturers need to train each and every one of their employees on the procedures and processes that consistently result in an optimal product. Some manufacturers may be tempted to only train managers in a comprehensive fashion; this won’t work in the medical device industry. Without understanding the importance of the procedures, their nature and their rationale, workers may modify procedures in an effort to increase productivity, to make their work easier or in a misguided attempt at process improvement.
While erasing these challenges completely may not be possible, they can be significantly mitigated by consolidating to a contract manufacturer. Some OEMs take a hybrid approach, where they manufacture some products or components and a contract manufacturer produces others, while other OEMs fully offload manufacturing responsibilities to a contract manufacturer. Either approach makes dealing with these three key challenges significantly easier.
Rather than vetting numerous suppliers for each individual component, an OEM only needs to vet their contract manufacturer. Since they’ll be the one sourcing supplies, there should be a high level of trust between the OEM and contract manufacturer; if the trust is there, however, then OEMs don’t have to spend the considerable time and energy it takes to evaluate every single supplier.
So long as the industry’s supply chains are distributed globally, there will always be the risk that a critical region will experience a crisis, disrupting that link in the chain. Working with a contract manufacturer doesn’t fundamentally change this, but it does afford greater flexibility.
For one, manufacturing is all that a contract manufacturer does, a focus that translates into greater, more specific risk mitigation. Where an OEM may have numerous business units with their own resource needs, a contract manufacturer only has to worry about manufacturing. When that capacity is impacted, they’ll have a greater share of their business’s resources available to deal with the issue.
Furthermore, should an OEM’s contract manufacturer fail to fulfill their duties, the OEM can always go to another manufacturer in a less impacted region. While there is some cost to switching between manufacturers, it is far lower than if the OEM had to shut down their in-house manufacturing operations and move it to a completely different region themselves.
Quality assurance is always going to be a top-of-mind challenge for medical device manufacturers, but working with a contract manufacturer does reduce the burden on OEMs. The clearest benefit of working with a contract manufacturer in this regard is that the OEM doesn’t have to train their own employees — they merely need to provide design specifications to the contract manufacturer, who will then oversee training at their facility.
Again, because of their specialization on manufacturing, most contract manufacturers tend to have high-quality adherence to quality standards. And if quality assurance does become an issue, then the OEM has the option of switching to a different contract manufacturer with a better reputation.
There's no shortage of unique challenges for medical device manufacturers, but they are not insurmountable, especially not if you use a contract manufacturer. If that’s the route you decide to take, make sure you do your due diligence — the number one factor that predicts how well a contract manufacturer can mitigate your medical device manufacturing challenges is the level of trust between you and your contract manufacturer.
