Tiger Team: Optimal Risk Management and Sustainable Production of a Medical Device

Session Id: IH09-RT231 Type: Downloadable

Description

Bringing a new implantable medical device to market involves meeting and harmonizing numerous requirements. A Tiger Team illustrates roadblocks to production and the role of the industrial hygienist in resolving potential conflicts among stakeholders, in achieving appropriate risk management, and in achieving sustainable production. Babyboomer Hips and Knees, a manufacturer of implantable medical devices (artificial hips and knees), is moving production of the new Turbo-Extreme knee replacement from Europe to the United States. A key process chemical is sold only in Europe. Trichloro-chickenwings, the only alternative acceptable to the FDA, faces stringent EPA and OSHA regulatory constraints. Production has halted. A Tiger Team has been assembled. The team includes management, industrial hygiene, environmental/regulatory, marketing, quality control/FDA regulatory, engineering, the device inventor, inhouse counsel, and a key outside supplier from California. At the initial meeting, team members reach a stalemate. At a second, more productive meeting, the CIH representative is instrumental in showing a holistic, productive pathway to breaking the stalemate. Speakers and attendees are provided with a scenario and a biography.
$24.95
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