The Many Hats of an Integrated Contract Manufacturer and How Each One Fortifies Your Medical Device Supply Chain
In its 2020 report, Risk, Resilience and Rebalancing in Global Value Chains, McKinsey Global Institute includes a graph plotting different types of ‘shocks’ and their potential to disrupt value chains around the world. It includes everything from trade disputes to man-made disasters to changes in regulations to financial crises.
On the graph, each shock is assigned a value according to how easy it is to anticipate and the amount of potential costs. At the very top of the cost axis, above ‘global military conflict’ is a plot point marked ‘pandemic’. Estimated to cost tens of trillions of dollars in damages, the only greater economic impact would result from disasters that have not yet occurred, such as a meteoroid strike or the eruption of a supervolcano.
Can your supply chain survive a supervolcano?
Resilience, or the ability to continue operating in spite of unusually tough circumstances, depends on whether your supply chain has been fortified by numerous critical factors. If it has not been inured against poor communication or financial risks, for example, it is on unsteady ground to begin with and will not endure major shake-ups.
The hidden value of integrated contract manufacturers for the medical device sector
The medical device outsourcing market is expected to double from the $52.9 billion it was worth in 2019, to over $100 billion by 2025. Much has been written about the bottom-line benefits of working with a contract manufacturer (CM). However, this article aims to highlight their critical role in building resiliency into your supply chain.
Here are the five hats your fully-integrated CM should wear.
The track star
It is not enough to know it all. A valuable medical device CM will also have it all: the people, technology, processes, facilities, equipment, certifications… everything necessary to deliver in the highly-regulated medical sector.
Your track star will have evidence of their excellent track record with both customers and regulatory boards. It will prove it has met the strict safety and quality requirements as set by FDA QSR and ISO 13485.
Resiliency is about dealing effectively with disruptions and stressors. In many countries – the US and countries in the EU in particular – continuously enhance regulatory oversight for medical devices. Your track star CM will have a full portfolio of success stories that benefit its customers; from welcoming (because they know they are compliant with) FDA audits to adapting design and production to comply with new regulations.
Riding out disruptions of all shapes and sizes
As a black swan event (an unexpected event with severe repercussions), COVID-19 was especially shattering. However, even pre-pandemic, many supply chains were vulnerable to much smaller disruptions. In good times, but especially in tough times, what you need from an integrated CM is a partner you can trust and one that can help you thrive, even during a pandemic.
That’s one hat that never comes off.
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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.