After Steady Growth, Plans New Office, More Hires

The Indianapolis-based startup, maker of quality management software for organizations in the medical device industry, plans to invest $651,022 in a new, 7,200-square-foot office at Union 525, a tech hub in the city’s downtown. The new office is part of an expansion plan now underway, and the company expects to create up to 120 jobs in the next three years as a result.

David DeRam,’s co-founder and CEO, says the company sprang from its founders’ combined 107 years of experience in the medical device sector, and their frustrations with an industry that seemed “stuck on legacy and paper systems.”

“Those legacy systems are not secure or integrated or easy to use,” DeRam explains. “We want to replace that with modern, cloud-based software so we can bring devices to market faster, with less risk and fewer regulatory struggles.”’s quality management software encompasses the entire regulatory pathway, DeRam says, and enables better decision-making by assisting with compliance, audit readiness, and visibility into the process. It automates the process of traceability, facilitates inter-team communications, and includes tools for design control, risk management , and document management.

The 22-person company launched in 2013, and has doubled in size each year it has been in business, DeRam says. has worked with customers in more than 26 countries across five continents and is nominated for two 2017 MIRA awards for Scaleup Company of the Year and Tech Service of the Year.

DeRam emphasizes that is the only quality management software built specifically for the medical device industry. The landscape is crowded with competitors, he says, but none that cater to medtech companies.

“General purpose quality management systems are a big market,” he says. “They say they can work in any industry, but something designed for pharmaceutical or aerospace companies won’t be a great snap-in fit with medical devices.”

The potential market for’s procuts is huge, he says. According to a 2014 BioCrossroads report, there are 30,000 medical device companies in the world. By 2024, DeRam says, the market for quality management software is expected to be worth roughly $12 billion.’s long-term goal is to become the top provider of quality management software for medical device customers. The company has a couple of unique programs to drive adoption. One of them incentivizes medical device consultants to become “partners,” while another is for seed-stage startups with $1 million or less in investments and revenues, and offers steep discounts and access to support staff. So far, growth has been so robust that DeRam says he had to “put new servers up” just to handle initial demand.

“People inhaled our content, which just shows how big the need is,” he adds. “We built it so device companies can put the hundreds of hours they spend on quality management back into their projects.”

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