A management compliance system might not be top of mind for most people, but through personal background and experience, Charcy Schultz, a self-described rule follower, sees it as an underrated but important step for startup businesses to get right.
“I was always the student sitting up in the front of the class. When I was a project manager (at cardiac safety service company iCardiac), I always loved the auditors coming in,” says Schultz, who now works at OpReddy, a company she founded in Rochester. “My colleagues going in would say, ‘Oh no, why are they here?’ but I would say, ‘Yes!’”
OpReddy, which marked its first anniversary in April and employs five people, streamlines the process of compliance and regulation for companies by digitizing the process. Through its software, documents are stored, signed electronically, and employees can get training certification through a unified, electronic system.
“Things can fall through the cracks (with a paper system),” says Thuan Pham, developer of the OpReddy software and founder of Phamiliar Technologies. “One client we had, they came to us after a FDA audit and said, ‘If I had this system, it would have saved me an entire week collecting documents together.’”
Although OpReddy is far from the only company that offers this service, it aims to be a catalyst for startup and midsize companies in Rochester, a group which Pham calls “the engine of our economy.” From lab testing to biotech ventures, several startups are already using OpReddy.
“Creating a startup in a regulated industry, there are all these huge hurdles. There’s not a lot of revenue at the beginning, but you still need to meet all regulations. You need to hire people and train them in compliance. If you’re a lab, you need to buy and calibrate equipment,” Schultz notes. “(OpReddy) helps with a small piece of this by maintaining documents and training. This will help them when it’s time to prove they meet those regulations.”
Brandy Young, CEO and founder of Certainty Analytical Labs, agrees that simply getting up and running is a costly endeavor that requires the startup to “burn a lot of cash before you make any profit.” Her business, a Rochester-based boutique testing firm, is focused on the hemp industry; it currently has only a handful of employees. When looking at other larger compliance software companies, Young found that they offered more than she needed and at significant cost.
“A small company like mine, it was too costly and overkill. (OpReddy) was easy to navigate, easy to onboard, and flexible to give me just what I knew I needed,” Young says.
Unlike other compliance software programs Young investigated, OpReddy’s monthly cost is based on services used, so she was able to pay for only what she needed.
Certainty Analytical Labs tests isomers, cannabinoid and dry weight potency for hemp and CBD distributors. Young says the lab is testing hemp flour, CBD oil and some marijuana gummies.
“This process is very regulated, so we, and our clients, need to make sure everything is correct in order to protect the customer,” she says.
While clinical decision support system VisualDx has more employees—nearly 100—than Certainty Analytical Labs, Veronica Benzing, a senior quality compliance writer, says OpReddy is still a good fit for them, especially when relying on remote work because of the pandemic.
“OpReddy is a great tool; this way, you don’t have to be sitting next to each other to accept your signature on a document,” says Benzing, who has worked on compliance with two other startup companies. “I know we wanted something less burdensome and simpler.
“The FDA has a huge time frame for keeping documents, sometimes 10 years in medical industries. That’s so much storage space we save and less trees we kill with this system,” adds Benzing.
VisualDx combines medical know-how and imaging technology to create software for point-of-care health decisions. Medical practitioners can use its image library, a search function for patients’ complaints or drug reactions, and a diagnosis builder. In addition, the DermExpert system can help diagnose skin problems with just a picture.
Most recently, VisualDx joined with Vaseline to launch the website, See My Skin, a tool for people of color to get access to better skin care information.
“If you search ‘itchy skin’ on Google, 96 percent of results are going to be Caucasian,” says Kim Montinarello, vice president of marketing at VisualDx. “We always made sure to have images for people of all skin colors. Partnering with Vaseline extends our reach to more and more people.”
AT Venture Center, another organization that uses OpReddy, finds value in the compliance software’s scalability. Similar to a technology incubator, AT Venture Center works with startups that may be alone in their field. For example, Regenerelle is one of few companies working to produce mesenchymal stem cells for research in diseases such as multiple sclerosis or Lou Gehrig’s disease.
AT Venture Center goes further than an incubator by sticking through the prototype phase, working to set up companies to be fully sufficient. Because of that long-range timeline, it is necessary for compliance systems to scale with the growth of companies.
“You don’t want to be the company that scales, but the product falls apart,” says Erin Crowley, president, co-founder and co-managing member of AT Venture Center.
Crowley sees a lot of tech potential for Rochester, which ranked No.1 in Jonathan Gruber and Simon Johnson’s book, “Jump Starting America.” Gruber spoke with the Beacon about Rochester’s potential in 2019. Crowley hopes one of the companies AT Ventures supports can be part of that process.
Montinarello agrees about Rochester’s potential, citing the rich scientific talent from UR and RIT.
“We have a team of software engineers, medical librarians, medical technicians, a wonderful imaging technician who used to work for the Eastman House. VisualDx is like the synthesis of all these elements,” Montinarello says.
At OpReddy, along with the digitized compliance process, there are plans to create modules for particular issues and a network of local experts that companies can seek advice from.
“We have such a wealth of talent and expertise here, from our universities to our technology industries,” says Pham, who would love for Rochester to become a Silicon Valley East.
“For example, imagine you don’t have a lot of marketing experience. You could quickly search for an expert in OpReddy’s network and ask, ‘I have this problem, how quickly can you help me?’ Usually it takes months to get a connection with a level of expertise. That’s all part of being a catalyst for startups.”
Adds Schultz: “I feel like OpReddy helps these smaller (fledgling) companies by giving them an easier start with compliant documents and training.”
Her background as a first-generation college graduate feeds into her self-identity as an underdog.
“It’s hard to navigate college when no one you know can help,” she says. “It’s hard to start a business in a regulated field and if OpReddy can help alleviate any of that, that fills my heart and soul.”
Jacob Schermerhorn is a Rochester Beacon contributing writer. The Beacon welcomes comments from readers who adhere to our comment policy including use of their full, real name.