There are a few tech companies in Bend building enterprise SaaS products for businesses in that mysterious middle: Too big for a simple, off-the-shelf solutions, but not large enough to afford costly, custom software employed by giant brands.
Simbaware is one of the newest in this realm. The startup has created a quality management system (QMS) for small to mid-sized, medical device manufacturers. Now forgive me for a sec while I unleash a flurry of acronyms on you: It’s QMS SaaS for SMBs. To help them meet FDA requirements. FTW!
So many letters. What does it all mean? Settle in for a few minutes because it’s time to learn something. First, the good news for anyone needing a medical device is that the FDA does not let companies just make them willy nilly.
Nope. Turns out you have to meet numerous requirements, and then report to the FDA that you did so. A lot of these smaller manufacturers are still using paper records and manual systems to document all sorts of things, from customer complaints to audits to non-conforming materials.
“But there’s a big risk in terms of non-compliance if there are gaps in your records or things that haven’t been filled out,” says Simbaware co-founder and CEO Manfred Walder. Those small mistakes not only cost companies big dollars in terms of FDA observations, warning letters, recalls and more, but the lack of visibility also allows inefficiencies to thrive.
Walder co-founded Simbaware last year as a way to affordably streamline and improve the quality processes for medical device companies with 50 employees or less. Turns out there’s nearly 10,000 of them. He says that much of the software on the market focuses on giant medical device companies – think Medtronic or GE – and is very expensive and complex.
“So those solutions are usually out of reach,” says Walder, who has spent much of his career working in quality management for large manufacturers. “At the other end of the spectrum, the QMS systems mostly lag and only cover parts of the quality system – they’re very limited in how they can be configured to meet the customers’ specific needs.”
And we’re back to that oft-ignored middle (related: my younger sister maintains that middles are routinely forgotten. Like left in the driveway as the whole family goes to the airport). Simbware is still in early days. They completed the first version of their software in December, and then ran a pilot program with a medical device company for the first half of this year. The co-founders discovered that their solution can save manufacturers 3% to 4% of their revenue via efficiency improvements, avoidance of FDA observations and recalls and reduction in loss of revenue.
The company has four employees. Simbaware’s Director of Sales and Marketing Dan Hill (formerly of Drink Tanks and Oregon Bioscience Association) is now reaching out to potential customers, introducing the product and garnering even more feedback.
“We’re focusing on saturating the west coast, rolling the product out and then moving across North America,” Hill says. The startup is also one of the semi-finalists BVC early stage competition. So you can hear from them directly at the Sept. 22 PubTalk.
A majestic lion via GIPHY
And lastly, because inquiring minds want to know … why Simbaware? Walder notes one of his co-founders, Emmanuel Nyakako, grew up in Kenya and wanted to use the Swahili word for lion in the company name. “We searched domains, Simbaware was available—so it worked out,” he says. Hopefully, we’ll hear this startup start to roar in the near future.
You can reach Kelly by email at [email protected].