By Anna Lardinois, Startup Storyteller
Spaulding Medical CEO, Amanda Baltz, is getting ready to showcase what the Menomonee Falls based MedTech company has been working on behind closed doors.
“The last couple of years we’ve been heads-down, developing our next-gen product and we are so excited about what we’ve developed to help our clients,” Baltz said. “We are in the final days of waiting for our 510(k) FDA approval.”
The company will soon release a new version of the remote cardiac monitor that made headlines when it was released in 2011 by Spaulding Clinical, and created so much demand that it resulted in the spun off company, Spaulding Medical. Baltz anticipates customers will embrace the robustly enhanced product.
The next generation product remains under wraps, but Baltz did share the process of developing the new product.
“We are a Class II medical device. Everything we’ve designed has been designed with quality and clients in mind,” Baltz said. “That means we have a very strict internal process of documentation and steps we have to follow so that when it comes time to show the FDA that what we’ve built is safe and effective for the intended use that we’ve stated, we’ve followed those steps.”
“We received our safety clearance in November,” she said. “That’s a big milestone. That is followed by an extensive series of performance tests to demonstrate and confirm that we meet or exceed the most rigorous clinical and technical performance tests.”
“I’m transitioning right now from a development mode to a ship mode. Not just to ship, but to create a scalable and superior experience that delivers extraordinary value for our clients,” Baltz said.
As the company moves closer to launching the new product, drawing investor support is important. “We are fortunate that investors have heard and responded to our story,” Baltz said. “Their support has provided us a running start to win new customers. It allows us to execute those contracts and move into a Series A from a position of strength.”
Spaulding Medical is a Wisconsin Economic Development Corporation Qualified New Business Venture (QNBV).
“I leveraged the Qualified New Business Venture for the Angel tax credits when I was raising funds for my first round, and it really did move the needle. Investors were not investing because of that, but oftentimes, before I even pitch an investor or an investment group, they will ask if we’re QNBV,” Baltz.
“I think there’s a level of sophistication as well,” she said, “if an investor knows that you’ve gone through that process, it’s also like a step of credibility for them as well, and that you’ve been certified.”
Baltz acknowledges that developing a new product in the midst of a global pandemic was a daunting task.
Reflecting on the last few years, Baltz said, “one of the things that I’ve had several investors share with me recently is they’re in awe of the tenacity and perseverance of our startup in one of the toughest hiring environments, one of the toughest funding environments and, one of the toughest supply chain environments.”
“For us to push through this period of time and come out on the other side has made us a much stronger organization, I think that’s been a huge testament to our team and the people who’ve been supporting us along the way…Our supporters know that we’ve got what it takes, and I think that’s made us really unique,” she said.
When asked how the company has managed to thrive during this challenging time, Baltz said, “first and foremost, I think we’ve been very blessed with really strong investors and partners in the market who understand the value of what we’re bringing. I’ve been transparent with partners and investors about what our need is to realize the value. When people understand what that need is, and they understand the value, they are willing to help move mountains for you.”
“You also have to have a level of faith,” she continued. “You have to continue to show up and give it everything you have. And if you believe in our mission and in the vision.”
“Doors continue to open,” Baltz said. “Like I’ve always said, if doors were closing and we weren’t getting positive signs from future customers, or current customers, then it would be a different conversation. But if the market continues to nod in response to the value, and the doors continue to open, you just have to have that perseverance and push through.”
To learn more about Spaulding Medical, connect with them here.