In 2006, 2-year-old Emily Jerry was killed when a technician mixed her chemotherapy drug with a saline solution 26 times above normal. The mistake, which sent the supervising pharmacist to jail, is not unique. Intravenous (IV) medication errors in hospitals can lead to considerable harm, or much worse, death and happen much more often than consumers are aware. The FDA received 56,000 reports of infusion pump incidents, including 710 deaths, and issued 87 infusion pump recalls between 2005 and 2009. It has been almost 12 years since the Institute of Medicine’s Report “To Err is Human” shocked the public consciousness and the medical establishment in 1999. Since then, much has been said and written about the problem, and there have been some significant steps forward.
S.E.A. Medical, a privately held medical device company dedicated to making intravenous (IV) drug delivery safer for patients is developing a line of products, some requiring no regulatory FDA approval, in an effort to be the solution to this ever growing problem. Their initial product, IV Check, which insures proper IV preparation, is being accompanied by Smart IV for IV administration monitoring, Auto IV for IV administration control, and IV Waste for documenting EPA and DEA compliance with IV returns and unused medication disposal. Where there has previously been no way to tell what is in a fluid, S.E.A. Medical can detect what is in a fluid, instantly report and accurately document what was delivered to patients. IV safety is the most critical unmet need in medication errors and IV management is underserved by existing technologies.
“We are developing products for IV preparation, administration, waste disposal and diversion detection,” said Dr. Michael Weickert, President and CEO of S.E.A. Medical. “Our products spring from the idea that really knowing what IV drugs you have prepared or are administering helps healthcare professionals perform their mission to care for patients with the confidence that they are keeping patients safe from IV medication errors.”
Business Development: For hospitals and universities seeking to eliminate IV errors, reduce the risk for wrongful death suits, and the resulting cost of malpractice litigation, S.E.A. Medical is developing products that directly address these problems. In addition, for manufacturers, or any other firms that produce and deliver IVs, the company’s technology could be significant.
An estimated 90% of patients receive an infusion while hospitalized and many of the highest risk medications (heparin, insulin, morphine, etc.) are delivered by IV infusion. A systematic review and meta-analysis of nine published studies indicated the overall probability of making at least one error in intravenous therapy was 73%, pushing the market value of safe drug preparation and administration products well into the billions.
S.E.A. Medical’s Products:
- IV Check: identifies drug and concentration and confirms medication preparation before it goes to the patient through a special fluid fingerprint
- Smart IV: monitors and measures drug and concentration, rate of delivery and cumulative dose
- Auto IV: controls administration in a pump eliminating error
- IV Waste: documents identity and volume of waste
The management team at S.E.A. Medical is well versed in industrial research and development. Dr. Michael Weickert has been President and CEO of S.E.A. Medical Systems since its founding in 2008. Prior to S.E.A. Medical, he was Chief Business Officer at Corium International, Inc. an established transdermal drug delivery company, and StrataGent Life Sciences, Inc., a drug delivery startup, where he managed marketing, business development, finance and assisted the merger of the two companies. He spent more than 8 years at Nektar Therapeutics, a premier drug delivery company, where he collaborated with Business Development on partnering efforts in the US, EU, and Japan. In 2000, he created an anti-infectives business unit that placed four products in development and formed the core of the $115M pulmonary business acquisition by Novartis in 2008.
Mr. James Bennett is co-founder and COO of SEA Medical. As a researcher with NEC Research Institute, he invented a new method of producing magnetic read heads. Mr. Bennett joined Symyx Technologies as an early stage startup and over a 10 year period, held senior research and leadership positions developing high throughput screening and fluid sensor technology products.
Dr. Leo Matsiev is co-founder and CTO of SEA Medical. He has over 20 years of industrial research and technology development experience. He received his Ph.D. in physics and mathematics from Moscow Institute of Physics and Technology and spent 5 years working for the Russian Academy of Science in the field of molecular physics and material science as Senior Researcher. Dr. Matsiev holds 38 US and foreign patents. He has a proven track record of creating novel technology and taking it all to way to profitable products and services.
The Interview with Dr. Michael Weickert below was recorded at the OneMedForum in San Francisco 2011.
See company profile and additional information here: http://www.onemedplace.com/database/list/cid/12251/