Company: Tangent Medical, Ann Arbor, MI
Entry Submitted By: Eye-To-Eye Communications, Inc.
Company Description: Tangent Medical is focused on the development and commercialization of IV therapy products. Founded in 2009, the company’s patent-pending NovaCath™ Secure IV Catheter System is the only safety IV catheter to cost-effectively integrate advanced catheter stabilization, passive needle encapsulation, tubing management and blood control. For more information, visit www.tangentmedical.com.
Nomination Category: Products & Product Management Awards Categories
Nomination Sub Category: New Product or Service of the Year - Health & Pharmaceuticals - Product

Nomination Title: Tangent Medical - NovaCath™ Secure IV Catheter System

Tell the story about this nominated product or service (up to 525 words). Describe its function, features, benefits, and performance to date:

The NovaCath™ Integrated IV Catheter System is a pre-assembled, closed IV catheter system that integrates advanced catheter stabilization, blood control, passive safety, full needle encapsulation, and next-generation tubing management on every IV start. NovaCath is designed to improve clinical outcomes, patient comfort, hospital compliance and healthcare worker safety, while exceeding highest OSHA, INS and CDC standards.

Tangent Medical recently received FDA clearance on the NovaCath as well as issuance of US Patent #8,323,249 titled "Integrated vascular delivery system." NovaCath was chosen by Premier, Inc. as one of 16 technologies to be showcased at their Innovation Celebration Program. Tangent Medical was named Most Innovative Company in a national contest of the 2013 Business Excellence Awards.

The Tangent Medical team believed developing an innovative closed IV catheter required the integration of multiple design innovations into a single, comprehensive solution to address unmet patient needs while eliminating the need for add-on products. The NovaCath’s development was done in remarkably little time, with minimal resources, and with tremendous success.

The commercialization of the NovaCath places it in direct competition with three large medical device manufacturers in a true oligopoly. In 40 months, Tangent Medical has evolved from having early product concepts, to being a venture backed company, to having a highly differentiated commercial product reinforcing that entrepreneurs and starts-ups play a critical role in medical device innovation.

The NovaCath’s innovative features: 

Advanced IV Catheter Stabilization - provides 360° stabilization around IV catheter insertion site. Reduces restarts, extends overall dwell time of existing PIVCs and minimizes occurrence of catheter movement complications. 

Closed IV Catheter System with Passive Needle Encapsulation – reduces occupational blood exposure risks and catheter hub contamination. Provides the highest level of safety and OSHA compliance. 

Next-Generation Tubing Management - unique, 180° internal fluid path turn eliminates the need for external tubing “J-Loop.” Minimizes snags, restarts and complications, while increasing patient comfort. 

Low-Profile Ergonomic Design - soft, flexible design supports high conformity to different insertion sites and patients. Provides ease of use for clinicians. Exceeds highest standards for stabilization and safety. 

NovaCath solves the following problems: 

IV Stabilization

An estimated 50% of peripheral IV catheters develop complications and require a “re-start” with another catheter. Inadequate IV catheter stabilization is the root cause of IV catheter complications. NovaCath offers Advanced Catheter Stabilization Technology on every start. 

Rising Health-Care Costs

Only 10% of U.S. hospitals utilize add-on stabilization devices resulting in challenges around IV catheter stabilization. Cost of an IV catheter restart is $35. Blood spill clean up adds additional cost. Complications from IV therapy is costly for patient, healthcare worker and hospital because they require longer stays and unplanned treatments. 

Blood Exposure

IV catheter insertions frequently result in occupational exposure to blood and/or needlestick injuries. NovaCath’s closed system blood control and passive needle encapsulation eliminates occupational exposure to the lowest feasible extent.  

Tubing Management

Creation and management of an external loop of tubing is time consuming and burdensome to clinicians, and creates significant risk for catheter movement and dislodgement. NovaCath eliminates the loop of tubing altogether.  

NovaCath objective: To be the safest, most secure and comfortable way to administer IV therapy, preferred by nurses, hospital administration and patients.

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Provide a brief (up to 125 words) biography about the leader(s) of the team that developed this nominated product or service:

Adrienne Harris, Elyse Kemmerer, and Steve White are the co-inventors of the NovaCath™ Secure IV Catheter System. They were members of the inaugural fellowship team at the Medical Innovation Center.

Tangent Medical was founded in 2009 as a spin-out of the University of Michigan’s Medical Innovation Center (MIC), which fosters innovations in health technology by assisting fellowship participants in turning their ideas into commercial products.

During the year-long process, a multi-disciplinary team spent months in the clinical setting observing and interviewing clinicians to get first-hand exposure into the healthcare system. The team honed in on the practice of IV therapy based on market size and belief that it was a largely under-served market. Thus, Tangent Medical Technologies was incorporated in 2009.

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