TECHLAB specializes in developing and manufacturing intestinal diagnostics that are used worldwide with a research focus on enteric disease and microbiology of the intestinal tract. “We are diagnosing diseases in very sick people,” Vice President of Manufacturing Steve Harvey says. “We try to have all of our employees imagine someone they know or love, or themselves having to use that test to make sure every single test we put out there is to the highest quality.”

Drs. Tracy Wilkins and David Lyerly founded the Blacksburg, Va.-based company in 1989 based on research that came out of Virginia Tech’s Anaerobe Laboratory where they were investigating diagnosis and treatments for Clostridium difficile infection. C. difficile is a bacterium that causes diarrhea and more serious intestinal conditions such as colitis. One of the reagents developed was an antiserum that could be used diagnostically.

Demand for the antiserum grew quickly when it was discovered that C. difficile is a major hospital pathogen. TECHLAB was incorporated to produce and distribute the product. “Here we are 26-plus years later and we are now over 120 employees, and a worldwide diagnostic manufacturer,” Harvey says. “That’s our main focus, but we are starting to branch out into other markets, looking at parasitology lines and some fecal markets that test for inflammation. A few years ago we got FDA clearance testing for E. coli.” This bacteria is associated with outbreaks from contaminated hamburger, vegetables and other food sources.

As an FDA-regulated diagnostic manufacturer, TECHLAB offers research and manufacturing services for industrial and academic clients. Clinical labs purchase its products to test samples and provide doctors with lab results that are used to help diagnose patients. “All aspects of our process are based around quality,” COO Rob Day notes. “Quality science, quality products and quality service. Quality – that’s the main word we like to hear and we hear it from our customers.”

Quality Development

As a worldwide manufacturer of diagnostic tests, TECHLAB consistently works to ensure its products meet the requirements of each country it serves. “I think some of the FDA testing guidelines have gotten stricter where it’s a little harder to get products through, but we are working in conjunction with them to achieve a resolution,” Harvey explains. “Overseas is where we see the major differences.”

Europe, China and Brazil are some of the company’s larger markets that used to be non-prohibited – TECHLAB manufactured a test to FDA standards and would sell it overseas. Today, the company says the level of reporting is more involved and the tests need to meet that country’s regulatory requirements.

TECHLAB employs four regulatory employees who work to meet international regulations, Day notes. “It takes gap analysis in our quality auditing process to identify the differences for Canada, Europe, etc., and we create a technical file for clinical data to put in definitive formatting,” he explains.

Lean Processes

TECHLAB’s patented cassette technology allows for different tests to be manufactured on the same platform. The basic platform allows for relatively minor adjustments in changeovers from one product to another.

The company has been proactive in adopting lean principles in manufacturing but, Harvey says, TECHLAB is just starting to scratch the surface. “I was asked one time, on a scale from one to 10 where we fell in lean processes, and I said one,” he adds. “It’s been a long journey, but we have seen lots of benefits by incorporating those. Science has steered away from lean manufacturing because it’s not really widgets, but we can take many of the tools and apply them to our processes. Lean techniques are consistent with and support our quality initiatives.”

Today, TECHLAB has four Six Sigma-certified green belts and the company is looking at applying lean principles in its office environments. “With all the regulations we move a lot of paper, so we are looking for ways to streamline those processes,” Harvey says.

Maintaining Excellence

TECHLAB maintains a core group of suppliers and deepens those relationships with frequent face-to-face interactions. The company locally sources as many materials as possible and is in the process of sourcing more from U.S. suppliers. “We are seeing the value is much better, the materials are better and the pricing is starting to become much more similar to sourcing overseas,” Harvey notes.

Most of TECHLAB’s processes are risk-based, so the suppliers it relies on most for biologicals and manufactured items are the ones it spends the most time with to develop relationships. “We build in quality from the moment the raw material comes in the door, all the way through every process until it leaves our hands and gets to the customer,” Harvey says.

Quality is communicated to every employee who is empowered to identify potential detrimental aspects in the manufacturing process. “They are encouraged to ask questions and look at things in a different way, and they know they won’t be reprimanded for slowing the process if their end goal is to improve quality,” Day explains.

Manufacturing employees are required to participate in a week-and-a-half-long on-boarding process where they spend a day in each department to understand TECHLAB’s entire process. This helps employees understand how each department impacts the department they will eventually be working in.

Moving forward, TECHLAB plans to continue developing new and necessary products for the market. “We can’t be more specific than that because of FDA requirements,” Day says. “We are in the majority of the countries we want to be in. We have a global reach today, so we will cultivate new products and continue to grow the markets we are in.”