Serving as a Guide for New Product Development

IN2BEING, LLC

BY GENE PARUNAK, MANAGING DIRECTOR, IN2BEING

What does a pioneer on the Oregon Trail have in common with someone trying to get a new product to market? They both need a guide—someone who knows the road, who will walk alongside them and will help overcome the many challenges and obstacles along the way. in2being, LLC, Michigan’s leading medical and life science product development firm, is that guide.

In 2003, Gene Parunak and Aaron Kehrer were working together as engineers at a Michigan startup life sciences company. As they worked through complex design projects, they felt the need for a partner company to give them counsel and help bridge the gap between their skillsets as engineers and what was required to manufacture a finished product. No such partner was available.

As Parunak explains, “One problem was that manufacturers knew in general what they would be able to do, but we would have to put a mature design in front of them before they could give us specific help. We needed a partner who could guide us from the idea and initial design to something they could actually manufacture that worked how we intended.”

Over the next seven years as they worked design projects, Parunak and Kehrer learned how manufacturing processes work, where the limitations are, and how to account for those limitations in their design effort. They also learned how to design processes that would satisfy the expectations of the FDA and other regulators so that the product could get market clearance.

In 2010 Parunak started in2being, LLC, the company he and Kehrer felt they had needed years earlier. At first, Parunak worked alone at home with just a computer and some CAD software, and then a year later, Kehrer joined him. As their clientele and funding grew, they acquired equipment and employees to build prototypes. Since then in2being, LCC has grown steadily as has its capacity to serve its clients’ needs. Parunak continues, “Our culture is focused on continuous improvement. Each time we identify something we do well, we build on it with new roles and new employees. For us, those are major milestones in how effective we are in serving our cleints.” Today, in2being, LLC occupies a beautiful new facility in Saline and employs ten people.

As a new product development guide, in2being, LLC offers much more than mere consulting: the company doesn’t simply tell clients what to do, but walks alongside them every step of the way, shouldering the burdens as a partner and helping execute critical tasks so they can survive and thrive.

As Parunak and Kehrer look to the future of in2being, LLC they plan to focus on increasing the company’s capacity for the three things it does well. First, in2being, LLC educates innovators so they understand the development pathway using everything from informal consulting to in-depth, two-day workshops. The company also lectures and mentors students in the University of Michigan’s biomedical engineering program. Second, in2being derisks client projects, helping to solve technical issues that impact device functionality so that it can move forward. Third, the company executes the development process to create manufacturing and regulatory-ready prototypes and documentation that can go out for regulatory clearance and manufacturing success.

The road to a fully commercialized product is a long one, in2being, LLC can be your guide.

IN2BEING.COM