Todd Grimm inspects one of the endotracheal devices produced at Rose Technologies. Photo by Johnny Quirin
Medical device manufacturer Rose Technologies has completed the rigorous process for ISO certification that will now allow the Grand Rapids company to add sterilization and packaging to its manufacturing capability.
“Expanding our ISO certification will put us in a position to potentially double sales in the next three to five years as the market recognizes our added capabilities,” said Todd Grimm, one of three owners of the company and its president.
Located on Front Street NW, Rose enjoyed a 12 percent increase in sales revenue in 2012 and predicts growth of 7 to 10 percent in 2013.
“The addition of final assembly, packaging and sterilization is a natural extension to our existing capabilities,” said Grimm. “Previously, we were a component supplier (to the medical device manufacturers) aligned with a few core competencies. Many of our customers, who may not have manufacturing capabilities, asked us to provide additional assembly services for them. With this ISO upgrade, we are now able to seamlessly provide those services.”
Some “finished device manufacturers” outsource much or even all of the production of their products, according to Grimm, and Rose is technically not a finished device manufacturer. Under the rules of the U.S. Food and Drug Administration, only finished device manufacturers are allowed to sell medical devices directly to hospitals or clinics. Rose’s customers are the finished device manufacturers.
His customers “would love to have the whole device built under one roof,” Grimm said.
With the ISO certification upgrade, Rose can now do everything in the production of a device except sell directly to the hospitals, according to Grimm.
Rose has held ISO 13485 certification for several years, he said, but went for the upgrade to allow it to build and package completed devices.
ISO 13485, published in 2003, specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and government regulatory requirements, according to the ISO organization.
The certification comes on the heels of the launch of a new endotracheal device Rose is manufacturing and packaging. One of the company’s core competencies is the ability to add fine wire reinforcement inside the soft silicone endotracheal tube, which prevents it from collapsing so that a physician’s high-tech instruments can be introduced internally in the patient via the tube.
All three of Rose’s founders/owners, Grimm, Eric Vroegop and Steve Grondsman, are engineers who have designed and built their own specialized manufacturing machinery, which enables them to win new contracts every year.
Rose Technologies is frequently challenged by clients to take a newly patented medical device and learn how to manufacture it efficiently. Grimm said it may be involved with six or seven potential projects each year but end up focusing on two or three.
“We speak the same language” as the engineers at the finished medical device manufacturing companies, he noted. “Once our foot is in the door, we don’t lose many jobs.”
Another strength of Rose Technologies is its three Class 10,000 clean rooms for the manufacturing, sterilizing and packaging processes. No more than 10,000 particles may be suspended in a cubic meter of air in the 10,000 classification. Each of the Rose clean rooms is about 1,000 square feet, and the third one was installed recently.
“We are pretty much maxed out in this building,” he said.
The company was launched in 1998, and by 2007 had about 21 employees. Now it has about 35 employees.
2008, when the recession hit, was a “rough year” for Rose, meaning its sales increases were just flat, according to Grimm. “Since then, we’ve been anywhere from 10 to 15 percent growth” each year, he added. The company just added its first full-time in-house sales and marketing manager, who will focus on the key areas for medical device manufacturing in the U.S.: New England, Minneapolis, California, Texas and Florida.
Has the Patient Protection and Affordable Care Act had an impact on the medical device manufacturing industry?
“We don’t know yet,” replied Grimm, but he added it is suspected of freezing the activity of the venture capital funds that invest in the development of new medical devices.
Many of the start-ups in the medical device industry rely on the venture capitalists to front them the money, and typically a startup’s goal is to successfully develop a new product that will then be bought out by the big finished device manufacturing companies.
“That money has dried up somewhat,” he said, but he added, “There is lots of money sitting on the sidelines, ready to go.”