Although the medical device industry has seen nothing but growth over the past few decades, that same growth has been routinely hindered by the systems and capacities that produce these devices.
As demand for a product grows, supply has to keep up, but now due to a mixture of manufacturing capacity and increased regulation of medical devices and the systems that develop them, some stakeholders are warning that the industry could be experiencing a manufacturing bottleneck that threatens to undermine much of the progress gained after the industry sought to shore up its supply chains in the post-pandemic era.
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This issue is magnified when the devices that are produced have to be built to extremely specific standards, with accredited staff and facilities required to meet regulatory requirements across several territories.
GlobalData analyst Alexandra Murdoch says the market is facing a mixture of two major factors – extended costs, and well-meaning regulation, which are slowing down the medical device production pipeline.
One of these big hurdles has been the introduction of the European Union’s (EU) Medical Device Regulation (MDR). Initially introduced in 2017, the EU MDR ruling has been somewhat tumultuous in its planned rollout, with new standards and measures set to come into force in 2021 but later adopted a series of extended timelines that would allow certain classes of devices to avoid compliance until 2028 at the latest, at least in the case of sterile measuring equipment.
Across the medical device space, the rising cost of parts, labour, and facilities has been felt particularly keenly since 2020. In a statement published in 2022 by industry pressure group MedTech Europe, the group pointed to soaring costs across the board in all areas of manufacturing and called on governments to consider offsetting some of these costs if they want to avoid a crash in supplies.
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By GlobalDataThe statement reads: “The steep rise in international oil and gas prices has resulted in higher energy costs that seriously impact manufacturing costs. Furthermore, global raw material prices are skyrocketing, resulting in all products and commodities reliant on these materials becoming more costly. In addition, global shortages of key supplies such as semiconductors, packaging materials, resins, plastics, and surgical grade alloys – all of which are key to medical technology manufacturing – have also contributed to significant price increases.”
Getting around it
With a bottleneck forming around traditional manufacturing processes, the market is looking for ways to circumvent the challenge. Several methods have been presented to address the issue, but none so readily adopted across a myriad of indications and industries as 3D printing.
The method works by way of a simple computer-controlled nozzle that melts a material, usually a form of plastic, into a specific shape within 3D space. This can be used to simply form 3D objects in a way that is much faster and much more capable than older mechanisms. Initially, if a designer wanted to mould a plastic housing for a device such as an insulin pump they would need to create a single master mould for the device, copy it multiple times to scale up production, and inject plastic into that mould repeatedly. A slow costly process involving multiple members of staff and machines.
The process of 3D printing requires a single printer and a pre-loaded design. Initially, 3D printing was seen as something of a mere novelty given that the plastic structures, they were able to produce were often flimsy or light. But as the technology has advanced, 3D-printed components have risen in terms of construction quality, making it ever more a reality.
As a result, the 3D printing market size is estimated to have been worth $23.2bn in 2023.
One market that has been hit particularly hard in the post-pandemic era for production is the quickly levelling out market of diagnostics, and at-home diagnostics.
For many diagnostics companies in the wake of the Covid-19 pandemic, many had hoped to translate the increased attention and investment into the industry into more varied and marketable tests post-pandemic but found that rising costs and a plateau of demand left them unable to maintain that level of production at the same rate.
Such was the case with Siemens, who, as a result, shuttered its manufacturing facility in Flanders, New Jersey, in hopes of reopening it later in Ireland at a reduced size.
The designing of specific bespoke parts for diagnostic devices has always been particularly difficult given the range and verity of electronic devices that could vary between each item based on its need. Microfluidics has been one of the areas of growth in this space since its inception which may present a possible alternative for at least one area of the market.
Microfluidics are systems that handle minute amounts of liquid within an enclosed system. It is typically used to transport, mix, separate, or otherwise process fluids, something which researchers previously had to do manually. Previously, the diagnostic devices that could achieve the same effect would have to have a specific bespoke design. With microfluidics, developers can produce more specific devices at a smaller and lower cost.
Speaking with Medical Device Network, Parallel Fluidics CEO Josh Gomes said: “I come from a very mechanical background, and we’re trying to solve all the classic problems that mechanical engineering consultants have to solve.
“Before we could not find a manufacturer that could turn around custom devices fast enough for us. We would have a concept; you go out and get a quote from different manufacturers and the time stretches into months and the cost to actually produce a first run of devices can end up being astronomical.
“But there’s a bit of a physical limit to what you can do with that traditional kind of robotic automation. In mechanical engineering, you can turn around a custom part with fabrication within days to weeks.”
As a result, Parallel Fluidics has seen its specifically developed fluidics systems taken in by several diagnostics companies as the company looks to offer an alternative to traditional manufacturing systems that have so far not been able to keep up the fast-moving pace of the international medical device market.
It remains to be seen how the manufacturing sector aims to keep up with the increasing number of medical devices, assays, tests and systems. All these sectors will need to utilise some form of manufacturing process and as that demand expands with the rest of the industry it will increasingly place pressure on the manufacturing sector.
Whether it is through 3D printing or other means, the industry will have to start pushing some of the frontiers of manufacturing technology to keep up with an ever-exponential demand on what is quickly becoming a bottleneck in need of breaking.
