What do billionaire and 2012 presidential candidate Mitt Romney and BioTeknica co-founders Ruben Capo, Braulio Ortiz and Jorge Rodriguez all have in common?
The answer? Baxter Diagnostics.
In 1984, Romney started the global private equity firm, Bain Capital, and about a decade later purchased Baxter Diagnostics. After the buyout, Ruben, an electrical engineer working at Baxter, thought about starting his own company, and in February 1996 he launched Controlled Concepts, an automation, engineering, and validation services firm. Friend and fellow Baxter co-worker Jorge would moonlight with Ruben on several projects. As business began to pick up, Ruben and Jorge approached close friend and colleague Braulio, a former Director of Operations and Engineering at Baxter, whom Ruben had met in the early 1980s, during their time at American Dade. They invited Braulio to join them in the new venture.
Later that year, in June 1996, the long-time friends launched BioTeknica, an engineering, quality and regulatory compliance consulting firm. Who was their first client? Telectronics, a heart pacemaker manufacturer who needed validation support as a result of an FDA Consent Decree. With growth as a priority, the trio hired another former Baxter employee and close friend, Steve Maltz, to head up sales for the fledgling company.
From day one, they rolled up their sleeves, often working long 16-hour days. They worked hard and played hard too. “We were avid softball players,” reminisced Braulio. “We would jockey to recruit the best team in the intercompany league, imitate ‘Charlie Hustle’ and battle for each win. Win or lose, after the games we would drink beer, eat pizza and often go home bruised and battered. Whichever team won the league got to talk smack for the rest of the year. It was great fun and allowed us to exercise our competitive juices!” he laughed.
World’s Top Life Science Companies Turn to BioTeknica
This same spirit of “do or die” has carried through in their approach to client work. Since its inception, BioTeknica has worked with hundreds of the world’s top life science manufacturers, providing engineering, quality and regulatory solutions for the medical device, diagnostics, pharmaceutical, and biologics industries. The firm’s core services include:
- Regulatory Compliance
- Quality Engineering
- Inspection Readiness
Today, with an expert team of more than 70 skilled scientists, regulatory professionals and engineers, they bring proven industry experience to every project.
“We’re fortunate that we continue to grow,” said Jorge. “We continue to attract talent – the best in the industry.” Most recently, two employees became principals, Mike Neaves, who serves as the firm’s Director of Regulatory Compliance Services, and Julie Larsen, Director, Inspection Readiness Services. Armin Torres, Principal and Senior Software Consultant of the firm, also heads up Qualified Data Systems, a Software Quality and Information Technology consulting firm spin-off of BioTeknica.
They have an astoundingly successful track record of solving regulatory and compliance challenges including the largest Consent Decree in FDA history. When complimented on their success, the three self-effacing co-founders often seem a little uncomfortable. It’s because they attribute their success to their team of experts. “We would be nothing without our incredible staff!” said Ruben proudly.
How Well Do You Know BioTeknica?
To find out which BioTeknica principal is an award-winning ballroom dancer, stay tuned for the next issue. Who do you think it is – Ruben, Braulio, Jorge, Mike, Julie or Armin? Click here to send in your response. Those who submit one of the first five correct answers will receive a small donation to their favorite charities.