The medical industry has been flipped on its head, spun around in the dryer, and put back on the ground since the beginning of 2020. But that isn’t to say other challenges weren’t present in the industry before the COVID-19 pandemic. So, what’s up these days?
Manufacturing Challenges – Even Without a Pandemic
First, let us revisit how things were a few years BC (Before COVID). Working in medical manufacturing was never a walk in the park. Anyone in the industry understands the importance of designing their manufacturing processes with IQ/OQ/PQ protocol at the forefront of their brains with the ultimate goal of meeting compliance. That is all well and good, but with the impressive evolution of medical products this is a constant challenge.
Connectivity Changed the Game First
RF devices were always a challenge for the medical industry. There was a lot of skepticism surrounding privacy-invasion, safety, high power-consumption, incompatibility with other devices and RF interference. This put a stop to any major development in wireless communication for medical devices. Then came Bluetooth Low Energy (BLE). Suddenly, a commercial world of possibilities opened up and we now have access to hundreds of new healthcare devices.
With Great Devices Come Great Responsibility
Take wearables for example. It’s not like one Fitbit came out and it was perfect and everyone was happy. Absolutely not. These devices are designed, improved, and constantly upgraded – just like every good device out there. A few things need to be considered simultaneously. First, (always first) is compliance. With every product revision, standards need to be met and approved. This can be more easily resolved with proper data management and documentation.
But then there’s volume. When developing products for every person’s use versus limiting them to medical professionals, you’re going to need more! Manufacturing factories had to ramp up to accommodate demand. Particularly when the demand is growing so quickly that competition is constantly breathing down each other’s necks.
But quality is always the priority and with devices becoming smaller, components are shrinking too. This is a hard hurdle to overcome with assembly and inspection being performed manually. As a result, a lot of medical manufacturers have switched to automated vision inspection, as well as semi or fully automating their assembly and test processes. Automation delivers the consistency required for repeatable results much more quickly than a technician is physically capable.
And Then Came COVID…
The COVID-19 pandemic has opened everyone’s eyes to the issues surrounding the medical supply chain. It hasn’t been pretty, but no one can argue that companies haven’t stepped up. With companies like Medtronic sharing ventilator designs and automakers stepping up to meet volume demand, we got where we needed to go. But at what cost?
Everyone is concerned about the economical impact of COVID-19. Governments all over the world are pumping billions of dollars into getting the world to the new normal. This money covers vaccine research, supply chain performance to distribute the eventual vaccine, support for companies to remain in business and relief for people who have lost their jobs as a result of the pandemic. The scariest part is that we’re not there yet. With the vaccine still under development, this isn’t over.
What this means is that the new normal needs to include proactive measures in medical manufacturing to be ready for the unknown. To re-live not having necessary medical equipment including protection gear for people putting their life at risk is unacceptable. This will be a new challenge medical manufacturers will face, as it will change their entire business model. Luckily, with the technological advancements in smart factories and IoT this is attainable and businesses can remain profitable through automation. Hopefully, the lesson is learned and companies are already gearing up to avert disaster!
To speak with a test & manufacturing expert, please contact Averna.
Looking to focus on product quality?
See what our test experts had to say during our most recent webinar: “4 Ways to Improve Quality and Accelerate Medical Manufacturing”.
Get in touch with our experts or navigate through our resource center.
