Since the Covid pandemic, medtech companies have placed greater expectations on their medical device manufacturers, driven by the need to bring devices to market more quickly.
Consequently, the advanced manufacturing industry has seen an acceleration in the requirements associated with producing complex medical equipment. The shift has increased the imperative to adopt digital commissioning in order to meet tighter production timelines.
In advanced manufacturing, digital commissioning relates to the use of digital tools such as virtual models, simulations, and automated validation systems to design, test, and verify production lines before physical equipment is built or deployed. Collectively, these factors are intended to ensure that potential issues that could create bottlenecks in the overall manufacturing process are identified early and minimised.
The US Food and Drug Administration (FDA) launched the case for quality (CfQ) programme in 2011, which centred on encouraging device manufacturers to prioritise product and process performance. The Medical Device Innovation Consortium (MDIC) later became involved with the CfQ, resulting in the development of the voluntary improvement programme (VIP).
This initiative sought to assess medical device manufacturing sites to assess capability and performance of key business processes and encourage participants to advance manufacturing processes, with many of the initiative’s outlined maturity practices such as automation and process monitoring achieved using digital tools.
Medical Device Network spoke with Andy Glaser, vice president of strategy at ATS Life Sciences Systems, an advanced manufacturer for the medical device, diagnostic, and pharmaceutical industries, to learn more about the current state of digital commissioning tools’ application in the manufacture of equipment for the medical device industry.
This interview has been edited for length and clarity.
Andy Glaser, vice president of strategy at ATS Life Sciences Systems
Andy Glaser (AG): Covid came quick, and the demand for medical equipment such as diagnostic devices spiked through the roof, and since then, this “I need it now” cadence has continued.
While this is great for business, Covid effectively caused a behavioural shift which has meant that a range of priorities, such as product development and time-to-market, tend now to overlap and need to be dealt with simultaneously from a manufacturing perspective.
An inherent conflict has now arisen between time to market and the design of a company’s device not being done. This is a real problem because when you have to urgently produce sellable product, after validation and beyond assumptions that the product’s actually reliable, the product’s entire developmental life cycle has been disrupted. This is because this developmental life cycle now overlaps with factors such as R&D, prototyping, and optimisation.
This all comes at a time where the labour force continues to struggle with availability of skillsets that can run complex equipment, while the devices themselves have become increasingly more complex, both in process of how to assemble and inspect them. And then there is the component of reliability.
Overall, there is this convergence of a lot of variables, with the expectation that we’re on time to market, all while ensuring the device is functional and will not be subject to any recalls. For advanced manufacturing providers and system integrators, this convergence is reshaping how complex medical devices are brought to market.
AG: A large player in the healthcare space had an FDA recall on a molecular platform. Not that long after it was launched, we were given two lines, which had to be delivered in 16 and 18 weeks, at 300 parts per minute. That’s unheard of. We had access to the US military if we wanted to fly robots in from Japan, we had anything and everything available to make this happen.
To reconcile that situation, we aligned with the customer that we would take full ownership of the machine design and guarantee output. In that case, it was a mature device, but we have had other customers that had the same exact situation, who did not have a mature device or a frozen design.
Those projects went red quickly, both for us and the customer, meaning schedule impacts, cost impact, and more because ultimately, the engineers didn’t know what to engineer, because the customer didn’t have a frozen design. This leads to a high sensitivity to variation from how you assemble these devices, and a high variation of how that device performs from one device to another, because no two devices are ever 100% identical.
This means assumptions made in the physical world shift as the device design slightly changes, which introduces dimensional and process variation in manufacturing.
Our job becomes one of how to mitigate this sensitivity to variation. The convergence of time to market and sellable product is now moved so much from the right side of the development curve to the left that sensitivity to variation becomes stressed. And being given specification requirements from a customer that are incomplete and have not been finalised further exacerbates this issue.
We know that all these hazards are not going away; and to help with this, digital commissioning is already proving to be a gamechanger.
AG: Digital commissioning helps reduce risk in scheduling and cost, to launching machines for a customer on time. It serves as an insurance policy to save time and money before you ever cut steel or aluminium to actually build a machine, thereby minimising risk on the back end of a project.
The other major aspect is training. Training often gets pushed out to the side; it’s scrunched due to time-to-market deadlines. But by not training operators well enough, the ability to recover from errors and complete ramp up initiatives is disrupted. However, with a virtual model that’s identical in terms of emulating code and mechanical systems, with accurate kinematics of any motion device, weeks can be spent on training if needed.
Another key virtue is validation and being able to put manual sheets and instruction templates into a digital environment. By starting this digital validation journey early with the initial user requirement specifications, months can be saved in a product’s manufacturing cycle.
In effect, with the application of digital tools, the margin of error is minimised throughout advanced manufacturing processes. Ultimately, this compresses time to revenue while reducing regulatory and operational risk.
AG: We provide an automated machine that will produce a customer’s product at scale, yet we have no visibility today, digitally or physically, whether or not the performance of that product will meet its inherent design — that’s truly still on the customer.
This is where digital commissioning needs to go to. If we give a digital twin model to a customer for a machine that produces a device, and they can manipulate the digital models quickly, rather than having a physical machine, now you can digitally modify a gripper, for example, or the way two parts are held. You can quickly look at the ramifications of a slight design change on the machine impact.
However, the holy grail is being able to incorporate how the device performs. For example, let’s say an auto injector has to deliver a certain force into a patient’s thigh to ensure they get the drug. You can do simulations analytics, but there’s the matter of tying the machine’s ability to produce that injector, to ensuring that that quality and performance of the product is connected together, rather than separate, which is what they are today.
It would be a major advantage to be able to virtually test design changes to a product, not only on how the machine will be built, but also on how that device will perform. This really is the holy grail, since it would then be possible to execute these tasks far more quickly, and with immediacy.
“The medical device manufacturing crunch” was originally created and published by Medical Device Network, a GlobalData owned brand.
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