EnvisionTEC has now also become the solution to COVID-19 testing for millions of patients in the U.S. 

Healthcare Performance Insider connected with Mr. Siblani to discuss this journey, the impact EnvisionTEC has had throughout the pandemic and a glimpse of the future of 3D printing.

Ready
Looking back, Mr. Siblani is strong in his conviction that we should have recognized the supply chain shortage of swabs earlier. We should have looked at it closer back when China was having problems. We should have anticipated that back in October as opposed to February. We would have been able to act a lot differently, been able to test people more aggressively, with a swab available in February. Noting this however, he shifts quickly to discussing the solution. Most entrepreneurs do not spend a lot of time dwelling on the past and Mr. Siblani is no exception.

Set
Like many times before, EnvisionTEC received a call from the market to meet a unique need. This time, the answer would be heard around the world – literally.

I was called by a hospital in Michigan who, at that time, had 38 patients that were choking because they were severely suffering from COVID-19, having breathing problems. The hospital only had 18 ventilators. We responded by printing splitters for them, allowing 36 of the 38 patients to be put on a ventilator. Within 24-hours of that delivery, I tested positive for COVID-19.

Being sick at home gave me a lot of time to focus on helping to solve the problem of the swab shortage. The fact that I was now one of those people that would be have a problem getting tested because of the shortage gave me more ammunition, and more energy, to overcome it.

Go
News of these events got out and Mr. Siblani was contacted by the White House seeking his assistance in identifying solutions. When I got the call, there were only 600,000 swabs in the country for COVID-19 testing. The President had ordered planes to go to Italy to get additional supply but only 500,000 were available. That is when I launched a study to prove the 3D swab I had created was as good as, or better than, the swabs we were going to other countries to obtain.

 
It took Mr. Siblani and the EnvisionTEC team exactly 22 days from concept to delivery of a 3D printed swab to test for the COVID-19 virus. He went through 17 different design iterations, personally testing the collection process of each. There were three specific requirements the swab had to meet:

1. The swab material had to be extremely flexible to account for all nasal passage types, i.e. someone with deviated septum.
2. The mechanical properties tested included torsional strength, elongation, and break.
3. The swab had to be easy to use, work with PCR testing and collect enough virus to deliver a result.

Once a prototype was complete, EnvisionTEC conducted a 150-person clinical study where subjects were swabbed with the current device and the 3D printed swabs. Through this process, several advantages of the EnvisionTEC were identified. Specifically, when sterilized, the EnvisionTEC swab has a 12-month shelf life compared to 6-months with other swabs. This led the FDA to grant EUA to the EnvisionTEC swab, one of 15 approvals to-date from over 65 submissions.

If you build it . . .

Concept to study was one thing. Now Mr. Siblani was faced with how to produce the swabs in the middle of a pandemic. We had to make a significant change (to normal operations). Swab production was a two-hour work structure. We sent a lot of the non-essential employees’ home to ensure social distancing during working hours and implemented a lot of new cleaning guidelines. Then we focused on satisfying the swab demands, as well as the demand for equipment for those who wanted print them at their facility. So, as a result of the COVID-19, we have been operating at 24 hours a day, six days a week.

To-date, EnvisionTEC has shipped over 3 million swabs for COVID-19 testing and is committed to making swabs for as long as they’re needed.

Given the fact that there is currently no vaccine, I think swab usage will continue to rise. As people want to go back to work, they need to be tested to do so safely. We are currently working with Fortune 500 companies that have thousands of employees to put testing facilities at their companies. We are also talking to universities that are looking to test their students once every two weeks as classes resume in the fall. I was just speaking to a university that has 25,000 students they want to test every 10 days – over two semesters that’s 550,000 swabs. 

EnvisionTEC has also developed channel partnerships with companies like Accumen to maximize the reach of their swab. We started looking for a, a partner that is very well connected to labs, hospitals, and health groups. We were being approached by many but chose Accumen because they have an incredible reputation in the market.

Profoundly Impacting Healthcare
Mr. Siblani remains passionate about the capabilities of 3D printing, now specifically focused on strengthening the essential medical supply chain in the U.S.

We have proven that, in a short period of time, we can rapidly expand the supply chain to satisfy the needs in the U.S. without relying on outside sources.

We need to look at how else we can use 3D printing to disrupt other areas.

EnvisionTEC is currently in talks with 3M, Chevron, and health systems across the country about other innovations. Currently, he is working on a breathable, custom printed mask with a silicone seal that can measure the output and input of carbon monoxide for up to 8 hours. According to Al Siblani, the possibilities are endless – and so are the needs.