The current state of medical device manufacturing operations

By Sergio Bellisario

We are acutely aware of the battles our frontline healthcare workers and their hospital systems have faced as they care for COVID-19 patients. The other sectors of the healthcare ecosystem continue to face battles of their own – the manufacturers, their suppliers and vendors, payors, and regulators. This complex interconnectedness is under tremendous strain as the Coronavirus pandemic persists.

For Medical Device manufacturers specifically, the challenges can be summed up in three words: throughput, agility and speed. How those challenges are being felt varies by sector.

Manufacturers of hospital/surgical supplies and equipment are struggling to increase capacity as they increase production of PPE and ventilators. They have been asked for a volume that was simply nowhere near their forecast. Their infrastructure does not have the capability to ramp up production at a scale this pandemic has demanded.

Diagnostics manufacturers are doubling down and working with pharmaceutical companies to get more testing devices out faster. They are looking for ways to speed up the analysis of blood as they look for cures and vaccines.

These issues are similar for all MedDev manufacturers whose products are needed to support patients, their providers, and their facilities in a pandemic. Throughput is not high enough, and the agility required to re-purpose capacity elsewhere is not enough. And time is of the essence – lives are literally depending on speed.

If we look to other sectors like Orthopedics, the problem is the other side of the coin. The demand for their products dropped to nearly zero early in the pandemic as elective procedures, or non-emergent procedures, halted. Many of their production lines still sit idle, and they are looking for creative ways to replace lost revenue. They are trying to “lift and shift,” retooling existing machines, processes, and people to manufacture products like ventilators. They have to shift product development as well as manufacturing change.

Because of their current processes or technology, it is hard for them to be agile or quick. Machines are limitations, processes are limitations, and people are limitations – not only from a skillset perspective, but from a logistics perspective as social distancing requirements are in play.

I know at least one orthopedic manufacturer that is simply not able to shift what they are doing today. They were at a virtual standstill. They were previously a highly successful enterprise. Their lack of agility, while previously a controlled problem they could overcome, became an existential problem.

These have always been critical aspects of manufacturing – throughput, agility, and speed. Some manufacturers that are well into their digital transformation journey far exceed their rivals in these areas. The COVID-19 pandemic has exposed the maturity of Medical Device manufacturers across the board.

While the digital roadmap for all manufacturers is at some point of development, the urgency behind that roadmap has been magnified. It is clear that digital manufacturing systems are required to compete today. Particularly the connections across product design and planning with manufacturing operations, and the ability to orchestrate changes in manufacturing at speed, while ensuring quality and efficiency.

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This article first appeared on the Siemens Digital Industries Software blog at