Rapid Prototyping is an Ideal Solution for the Medical Supply Chain

Example of swab testing for virus

The global response to the threat of Covid-19 has revealed in stark detail many of the serious problems in the worldwide supply chain for needed medical products like ventilators, diagnostic kits and personal protective equipment. Some supply problems are related to delays or inequities in various distribution channels. Others are due to a profit-driven system that has prioritized maximum cost-cutting efficiencies over redundancy and extra capacity.

Professionals have been warning us about these dangers for years and were quite prophetic in identifying exactly the shortages and delays we are now facing, but little action was taken.

Nothing demonstrates this more clearly than the case of nasal swabs. Let’s look at why this seemingly trivial appliance is so vital and how the lessons learned from its production can be used to inform smarter and more adaptive manufacturing decisions in the future.

What is a nasal swab?

The swab is a long, thin, flexible plastic shaft with a tip of flocked bristles. It is carefully designed to have variable widths along its length, so that it’s more flexible in certain areas than others. This allows it to negotiate the contours of the nasal passage as it collects a sample.

FLOQ Swab from Copan

FLOQ Swab from Copan

The tip of the swab is the critical part. It has sprayed-on nylon fibers arrayed perpendicularly to the shaft and with no inner core. The purpose here is to capture virus particles on the surface so they are not trapped as they would be in a cotton Q-tip. This virus sample can then be placed in a nutrient solution and sent to a lab for testing.

Who makes nasal swabs?

There are only two major manufacturers for nasal swabs in the world. One is Puritan Medical Products, Maine, USA. The other is Copan, based in Lombardy, Italy.

Having two companies provide the majority of the world’s supply makes sense only if the intention is to consolidate production for cost-savings, and it can be made to work if there is no extreme demand on the system.

Unfortunately, Lombardy, Italy was the epicenter of the Covid-19 outbreak in Europe. This lead to a major strain on the healthcare system (still ongoing), a massive disruption in swab production and thus a draw-down in available stock just when it was needed most. Even now we cannot meet worldwide demand for swabs, which means not enough testing. And as we know, a lack of testing is a major issue when trying to identify and isolate potential outbreaks and hotspots.

This is one of the fatal flaws in any public health system that is inflexible,  controlled by private patents and which doesn’t have the capacity to meet emerging local conditions. This would be troublesome in any supply chain, but for medical products it is catastrophic.

What is the solution?

3D printed nasal swabs

3D printed swabs from EnvisionTEC

 Recently a consortium of universities, hospitals, government agencies and commercial providers in the United States have come together to create a 3D printed nasal swab that is already FDA approved and ready to deliver swabs at scale, up to millions per week. Industry leaders include Carbon3D, Formlabs and EnvisionTEC.

All printing is done in ISO 13485-certified facilities, using readily available and inexpensive raw materials. Printed swabs are at least as effective as their flocked counterparts and can be quickly delivered to where they are most needed.

And since these files are digital they can be instantly shared with printers around the world, so long as they meet the regulatory requirements of their respective countries.

A Case For Rapid and Agile Manufacturing

 Mass manufacturing can be great for some commodities, reducing per-unit costs for maximum efficiency. But mass manufacturing is not good at responding quickly when market conditions change fast, as they recently have. Agile suppliers who are able to leverage digital manufacturing, rapid tooling, a robust supply chain and lean management systems can quickly provide tailored solutions that monolithic enterprises can’t match.

Star Rapid is an ISO 13485 registered manufacturer of rapid prototypes, rapid tooling and volume production for medical devices and more. Working together, we want to help you meet your urgent needs for medical product solutions when you contact us today.

 

 

 

 

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