The AM industry has been working closely with the medical community for many years. From the dental and hearing aid sectors, both of whom have adopted 3D printing as a primary method of production in a myriad of applications, to the medical and biomedical fields, who have integrated 3D printing into scientific research and the development of new medical devices, this partnership has yielded thousands of invaluable improvements into the daily lives of people the world over. EnvisionTEC has been at the forefront of these cooperative efforts since 2002, paving the way for new solutions that could only be made possible via 3D printing.
The 2020 COVID-19 pandemic has proven to be another opportunity for 3D printing to assist in finding new, innovative ways for healthcare professionals to provide assistance. A shortage of the necessary diagnostic and treatment supplies has been discovered, and while many businesses have jumped in to help, it is 3D printing that may be able to provide real answers for how to combat the supply chain crisis.
Working hand-in-hand with healthcare leaders, EnvisionTEC founder and CEO Al Siblani and his team of engineering and applications specialists, with the help of some dedicated customers have identified several areas where their specific strengths in biocompatible materials and fast, precise 3D printing equipment can help to provide replenishment of stocks as well as new, alternative solutions.
The main focus of EnvisionTEC’s efforts thus far has been on the lack of ventilators for increased demand, personal protection equipment (PPE’s), and nasopharyngeal (NP) swabs for specimen collection for testing.
Individual ICU ventilators are critical in the treatment of patients in severe respiratory failure, a symptom of severe cases of COVID-19. It has been determined that the demand for these ventilators will far exceed the current stock on hand. Manufacturing giants such as Ford and GM have been tapped to assist in the production of these machines, but even with the increased manufacturing capabilities, the process to get these machines ordered and in the hands of the medical professionals who need them could cause delays. Al Siblani has been working with local hospitals in the Metro Detroit area to provide a functional ventilation splitter that could be 3D printed in a Class 1 material such as EnvisionTEC’s E-Guide. EnvisionTEC is working with the FDA to authorize the use of 3D printed splitters as an emergency solution to allow for multiple patients to receive oxygen from the same ventilator by adjusting the pressure controls on the ventilators to allow for dual-patient use. By using 3D printing for these accessories, production could be scaled up in locations close to where the need is greatest, allowing for fast reaction to the growing problem and more than double the capacity of current ventilator stock.
In order to effectively treat the growing number of COVID-19 patients, healthcare professionals and many other essential workers rely heavily on PPE’s in order to safely maintain their own health. Many mask designs are meant to be single-use, and with the general public adding to the demand for these items, they are becoming increasingly hard to come by. Again, 3D printing is an ideal solution, allowing for portions of face shields to be printed and sterilized. EnvisionTEC has a number of large 3D printers that can quickly and efficiently print these parts in bulk, and many of their customers have been able to answer the call for local needs.
Perhaps the biggest immediate need in the fight against COVID-19 is simply identifying those who have been infected as early as possible. Testing kit availability has been vastly inadequate, and the medical community has been working tirelessly with the 3D printing community to find a solution to mass-producing the nasopharyngeal collection swabs to alleviate the shortage quickly. EnvisionTEC has been working closely with the Harvard Microbiology Lab within a larger group dedicated to connecting academia with the manufacturing industry to combat this shortage.
To this end, EnvisionTEC engineers have designed a collection tip for a flexible nasal swab. Brian Nilson, of Nilson Laboratories, 3D printed the final design for testing. He was able to print 400 of the swabs in Class 1 approved material E-Guide on his Envision One cDLM in two hours. The testing process is comprised of a ten stage mechanical testing, a two-part absorption test, a biological/chemical testing procedure to ensure the swab absorbs viral RNA particles and does not interfere with PCA/reagents, and a sample collection testing procedure. To pass, a sample needed to use a material that is approved as chemically safe would bend 180 degrees without breaking, and the design needed to be able to safely collect enough virus particles from the nasal passage to effectively test.
E-Guide has passed some of these tests and is awaiting final IRB testing and approval. Under FDA regulations, an IRB group that has been formally designated to review and monitor biomedical research involving human subjects has the authority to determine that E-Guide is suitable for the mass production of the NP swabs for COVID-19 testing. EnvisionTEC has long been committed to providing solutions to their customers and is now preparing to take on the call to action of helping to equip medical professionals with the tools needed to help combat this global pandemic with a vast network of thousands of customers eager to help.