Wednesday, July 28, 2010

Developing Medical Devices

SRI International and Stanford University School of Medicine announced that the Multidisciplinary Initiative for Surgical Technology Research Advanced Laboratory (MISTRAL) along with the Institute for Pediatric Innovation received a $1 million grant from FDA to commercialize innovative medical devices for pediatric care.

The key objective for the FDA funded project will be to develop new medical devices specifically to use in the newborn intensive care unit (NICU) setting. Other focus areas for pediatric product development will include surgical tools and catheter-related products.

“Children are the orphans of the medical device industry,” said Sanjeev Dutta, M.D., Associate Professor of Surgery and Pediatrics at Stanford. “Market and regulatory concerns often prevent medical device companies from investing in pediatric specific device development leaving some practitioners to use adult devices on children.

To improve opportunities for the successful commercialization of pediatric devices, researchers will work with advisors that will evaluate technologies and provide feedback on business plans. A venture-philanthropic program, the Pediatric Device Fund will be established to develop products that do not have sufficient market pull but products that would bring significant clinical benefits if brought to the market.

While observing surgeries and intensive care procedures, fellows at the University of Michigan Medical Innovation Center noticed that the current design for peripheral intravenous systems or IVs caused a great deal of hassle and had a high complications rate.

Researchers Adrienne Harris, Elyse Kernmerer, Merrell Sami, and Steven White started Tangent Medical Technologies, Inc., a medical device development company to change the way IVs are used for hospitalized patients. Tangent recently finalized its licensing agreement with the university to give the university an equity stake in the company.

The research project enabled the fellows to develop and commercialize Novacath a safer and more effective design for delivery of intravenous fluid and medication through peripheral veins. The patent-pending Novacath is currently in the prototype stage of development. In the near future, Tangent hopes to submit Novacath for FDA clearance and obtain a contract with a manufacturer for production and the sale of the device.

The Biotechnology Commercialization Center at the University of Texas Health Science Center in Houston is working with several companies to develop health and medical devices. For example, Colibri Heart Valve, LLC, a medical device company started by two physicians at St. Luke’s Episcopal Hospital, is working on medical devices to implant into the heart and vascular system. Colibri’s initial device is a novel heart valve implanted by catheter.

Another company, CorInnova, Inc. is a medical device company currently engaged in the development and use of innovative technologies to help heart recovery through the restoration of necessary mechanical stimuli. This minimally invasive technology promises to restore motion necessary for heart rehabilitation.

Nano3D Biosciences (N3D) Inc. is working on 3D cell culturing solutions. The company has created a simple device to magnetically levitate cells to enable 3 dimensional tissue growth. N3D’s “Bio Assembler” is an in vitro device that mimics the in vivo environment and has many major advantages over existing cell culturing methods. The company anticipates that the technology will address core needs in life sciences, drug discovery, toxicology, and regenerative medicine.

Doctors at Walter Reed Army Medical Center are using an electrical stimulation device to treat some of their patients for depression. The device called a repetitive Transcranial Magnetic Stimulation (rTMS) system uses electromagnetic induction which is the rapid changing of magnetic fields to create small electric currents that essentially jump-start the brain.

Lt. Col. Geoffrey Grammer, M.D., Chief of Inpatient Psychiatry at Walter Reed is compiling a team of researchers to develop new uses for the system and he thinks that the treatment could be used to exercise the brain of TBI patients.