In July 2020, EviroTECH founder and chief technology officer Dr. Gerardine Botte knew her team had developed something significant that could become a game changer for SARS-CoV-2 detection. Dr. Botte quickly filed a patent for the process. With timely support inputs from the Texas Tech University Innovation Ecosystem and the National Science Foundation I-Corps program, EviroTECH was born and embarked on the commercialization of the Ultra-Fast COVID-19 Detection Sensor.
Incredibly, our development efforts started more than two years ago and although the finish line is in sight, we’re not there yet. Bringing a medical device to market, even a “low-risk” COVID-19 testing device unlikely to cause harm to a patient, is an arduous process that involves careful planning, rigorous testing, intense quality control, scrupulous documentation, and the identification of key partners that can help make the vision a reality. Depending on the complexity of the device in question, it is not unusual for it to take three years or more to pull everything together. The prototype, working capital, design, FDA approval, and finally marketing and manufacturing—all must be perfectly orchestrated for success.
From the beginning, the team at EviroTECH knew they would need an experienced medical device manufacturing partner to bring their COVID-19 detection sensor to market. After searching the manufacturing sector for the very best, they found their ideal partner right here in Texas. Velentium, formed in 2012 by co-founders Dan Purvis and Tim Carroll and located in Katy, is the right choice for this job for many reasons—a reputation for quality, familiarity with the work and the demands of the manufacturing process, outstanding customer service, knowledgeable leadership, and an amazingly talented team to take the Ultrafast COVID-19 Detection Sensor from prototype to product.
But these aren’t the only reasons or even the primary ones why EviroTECH partnered with Velentium. Velentium is defined by its mission and corporate culture. Its mission is simple and direct, “We exist to help you change lives for a better world.” The company was founded to make direct impacts on lives through the products that it helps bring to market. The components of its name are also interesting and represent its approach to work. The name is drawn from velocity, momentum, and ingenium, a term coined by the founders that describes the ingenious talent Velentium brings to bear on every project it undertakes.
In addition to all the traditional steps that must be taken to get a commercial product to market, the process involves developing a regulatory plan, determining the classification in target markets, and establishing a quality management system. After all of that, the product development phase begins. In this phase, all things design must be addressed—inputs, outputs, verifications, validations, reviews, and changes—repeatedly until the device is exactly right and ready for regulatory submission and…product launch! After distribution has begun, the process involves keeping track of exception reports, required regulatory changes, complaints, external audits, and so much more A process like this could take years to navigate and with good reason. The responsibility associated with manufacturing and distributing a medical device is substantial.
As we previously shared, EviroTECH has been actively pursuing FDA approval since the company launched, carefully meeting all the requirements over the past two years. Securing the manufacturing details—who, what, when, where, and how—was a huge piece of the approval process. And we will keep advancing to realize the potential of the Ultra-Fast COVID-19 Detection Sensor.
Unfortunately, risks associated with SARS-Co-V-2 persist. The need for fast and accurate testing solutions persists as well. We must continue to be vigilant in our quest to determine infections and potential contagions quickly, in the workplace and in public gathering places. As of September, we were still losing approximately 400 people each day in the United States where SARS-Co-V-2 remains the third leading cause of death. Other countries around the world also continue to struggle with the effects of the virus. We must persevere in our fight to contain the virus, and accurate, rapid testing will lead the way.
Future pandemics seem inevitable. EviroTECH is committed to finding and developing new medical technologies that offer reliable solutions for medical testing needs and help combat viruses, diseases, and infections.