Tangent Medical is on track to launch a commercial product in March just four years after the company’s humble inception in Ann Arbor, Michigan. That is lightning fast in the life sciences world in which hurdles of clinical studies, FDA submission & approval, and compliance requirements present almost insurmountable challenges to even the big global companies.
Commercial manufacturing is a world away from the prototyping and small batch production required for clinical studies. Commercial manufacturing is hard. If commercial manufacturing is hard, “Life Sciences manufacturing is really hard.” said Elyse Kemmerer, co-founder and Director of Marketing at Tangent Medical. Elyse was one of the panel speakers at BioArbor’s “Insiders’ View of a Start Up: Year One” held on March 6, 2013.
Tangent was founded in 2008 after an in-depth clinical immersion research project done at the University of Michigan hospital that resulted in 130 findings of issues and problems across the hospital’s multiple care units. One issue bubbled to the top because of its commonality across all the care units. Elyse and her team observed that the traditional short-peripheral IV catheters were difficult to administer and uncomfortable for the patients. Their research showed that 50% of the 350 million IV catheters used in the United States every year developed complications. An improved IV catheter with greater safety, stability, and ease of use would improve patient safety and solve real problems for the health care providers.
With a viable business concept in hand, Elyse and her team dived into developing the new product. Like any new business, healthy funding is critical to the fate of a young company. In 2009 and 2010, a total of $1.25 million seed funds were obtained in a combination of the angel investment, SPARK match funds, and U of M matching funds. Tangent invested wisely in prototyping, clinical studies, and the FDA 510K submission. In September 2012, Tangent’s NovaCath Secure IV Catheter System received FDA approval and soon started the journey to begin manufacturing.
“What’s challenging is the Quality System.” Elyse said. Entrepreneurs with a background in science, engineering, or management have little exposure to manufacturing, let alone life sciences manufacturing. Even a seasoned production expert from the industrial or automotive industry cannot claim they understand the life sciences environment. Life sciences manufacturers are required to comply with the FDA’s predicate rules of Good Manufacturing Practice (GMP) and Part 11. The key is to make quality products under a compliant quality system with consistency and traceable history for accountability.
FDA’s current Good Manufacturing Practice (cGMP) requires systematic control of management, design, suppliers, material, production, and Corrective Action Preventable Action (CAPA). For example, a life sciences company can’t just buy from any supplier. Purchasing is a controlled process. Suppliers have to be qualified before the first purchase order can be cut. This means that life sciences companies will need to manage their suppliers through reviews, audits, and product inspections. As another example, Life sciences companies can’t just download any production software and install it. Production is a controlled process. So is the production software. The software vendor has to be qualified first as discussed above. Then the software itself has to be qualified through a process called computer system validation. Failure to comply with any of the above control points can lead to FDA warning letters or adverse events such as recalls and stop shipments. These nuances are big challenges to entrepreneurs. The knowledge of life sciences manufacturing is critical to the success of a start-up life sciences company.
“Tangent brought in a team of life sciences manufacturing experts and established a compliant quality system from the ground up in our Mexico production facility. We are ready to launch production next week.” Elyse shared this exciting announcement with the audience.
Life sciences manufacturing is not a sprint, but a marathon. An innovative viable product gets you in the race. Making quality products under a compliant quality system keeps you in the race. With the next FDA inspection never too far away, establishing and maintaining a production system that meets regulatory requirements in a cost effective manner is key to the success of a life sciences company. While innovation, commercialization, and customer satisfaction remain the focus for life sciences entrepreneurs, it’s never too early to start the conversation on GMP manufacturing.
LSPediA helps life sciences companies to get on board commercial production and to roadmap future growth opportunities through the offering of industry specific knowledge libraries and business consulting. LSPediA Libraries are consisted of a Standard Operating Procedures (SOP) Library and a Value Stream Process Library. Coupled with LSPediA regulatory services, LSPediA enables cGMP compliance, process improvement, greater productivity, and risk mitigation. For more information, please visit www.LSPediA.com.
About Tangent Medical
Tangent Medical is focused on the development and commercialization of IV therapy products. Founded in 2009 as a spin-out of the University of Michigan, the company’s patented NovaCath™ Integrated IV Catheter System is the only safety IV catheter to cost-effectively combine advanced catheter stabilization, passive needle encapsulation, tubing management and blood control. Based on extensive clinical research into the needs of both healthcare workers and patients, this next-generation system is designed to establish a new standard in catheter design, functionality and performance. For more information, visit www.tangentmedical.com.
BioArbor hosts educational networking events for the life sciences industry in the greater Ann Arbor area. BioArbor’s focus covers technology commercialization, financing strategies, business development, regulatory affairs and marketing. Each monthly meeting features a networking session and an invited speaker, followed by a Q&A period. Invited speakers share experience on topics such as drug discovery & development, medical devices, diagnostics and tools. BioArbor events are open to the public and are especially suited for those interested in starting or growing life science businesses. For more information, please visit http://www.bioarbor.com.