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Rochester Chamber Top 100: Company finds success through validation

Rochester Business Journal
November 18, 2016

Highpower Validation Testing & Lab Services Inc. is a secret weapon for a segment of device manufacturers.

The company helps to validate medical devices and helps companies, startups and individual inventors get their devices to the market.

“Essentially what we do is we’re a massive insurance policy for a device manufacturer to make sure that everything that is in writing about their device—how to properly clean it, how to properly package it, how to properly sterilize it—has been validated so that its reproducible in the real hospital or clinical environment,” President Gary Socola said.

The business started in 1987 as a department of SPS Medical Supply Corp.

In 2012, spouses Gary and Dawn Socola took over the sterilization division of SPS Medical Supply when the company was acquired before launching Highpower as a spinoff.

“It was a tough decision when you’re part of something for three decades, but we also knew that continuing to be included in SPS Medical that we were never going to grow and prosper and see what we could do as a company,” Gary Socola said. “It was a good decision.”

“We’ve been a lab for over 30 years, but we’ve only been able to market ourselves for about four,” he said.

The company has grown from 12 employees in 2012 to 22. Next year, leaders anticipate adding a handful of employees. The company is based at 125 Highpower Road in Henrietta.

It has been 40 years since federal regulation ensured FDA-approved medical devices, officials said. A lot has changed since October 1976.

“We work very closely with the FDA, and we know what they require,” Dawn Socola said. “They’re becoming more and more strict with their regulations.”

The history of sterilization in Rochester dates back to the early 20th century.

“Sterilization is still what it has been since the 1940s, but the bigger emphasis now is on cleaning devices, because if you can’t clean a device you can’t sterilize it,” Gary Socola said.

Today the importance of medical sterilization is more public than ever, officials said.

“There certainly is a lot more scrutiny in the public eye now as far as when mistakes happen in hospitals,” Gary Socola said. “When those things happen, there’s a heightened amount of activity around it.”

Highpower competes on a national and international scale, but Rochester is still known as a sterilization hub. The firm focuses mainly on the health care industry, which includes dentists and individual doctor’s offices, but also does some work in the industrial space.

“We work with the largest multibillion-dollar companies in the world, and we work with the orthopedic surgeon that built a widget in his spare time,” he said.

Working closely with the FDA allows the firm to keep up on today’s standards for sterilization and consequently helps customers meet requirements for their devices.

The company tests devices and sterilizes equipment under the worst possible conditions, such as leaving soiled items to dry for hours—things that would not happen in environments such as hospitals, officials said. 

For the Socolas, the past few years have been focused on the business side: learning payroll, establishing infrastructure and creating more value for customers.

“I’m glad we had to throw ourselves into it to learn it,” said Dawn Socola, the firm’s business manager. “It’s important that you learn all the mechanisms of your company from the ground up.”

In 2017 Highpower will continue to expand and focus on developing its employees.

“We have a great group of employees here,” she said. “I can’t stress it enough how proud we are of them and how proud I am that each one plays a role in the growth of this company.”

The Rochester Chamber Top 100 program is presented by the Greater Rochester Chamber of Commerce and KPMG LLP. Launched in 1987, it recognizes the fastest-growing private companies in Greater Rochester. The 2017 Rochester Top 100 event is slated to be held Nov. 2. For more information, go to greaterrochesterchamber.com.

Highpower Validation  Testing & Lab Services Inc.
Validation, testing and consulting firm that primarily serves medical device manufacturers.
Year founded: 2012
Top executive: Gary Socola, president
Current employment: 22
2016 ranking: 77
Headquarters: Henrietta
Website: highpowervtls.com

11/18/2016 (c) 2016 Rochester Business Journal. To obtain permission to reprint this article, call 585-546-8303 or email service@rbj.net.


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