There was a time when a physician with a penchant towards inventing could create something in the garage or basement and have a product to use for patient care in a short period of time. Alternatively, one of the major device manufacturers, such as Cook or Boston Scientific, would take a special “phone order” to modify an existing product to meet a physician’s unique needs. Late-night sketches on a cocktail napkin with the "next best endoscopic obesity device" were rampant. It was a common occurrence for a physician to have an audience before a group of “new technology” committees at a major manufacturer to see if the “experts” believed the idea was sound. Those days ….. sigh …. have disappeared.
Today, the physician-inventor needs to be a lot savvier and understand the nuances, roadblocks and tenacity of the medical device development process. This is rarely a situation where the physician can “go it alone.” A partner is required.
In order for a potential product to stand out, a number of important considerations need to be evaluated including:
1. Market analysis
2. Prototype development and cost
3. Working prototype development and cost
4. Regulatory requirements and limitations
5. Cost and complexity to manufacture and cost to distribute
6. Profit potential
In fact, in many arenas, the physician-inventor is required to carry the financial and regulatory burden through human trials before a device company will even begin to evaluate the technology.
DeLegge Medical is a unique organization whose mission is to assist in overcoming these obstacles. This may be as simple as a market analysis or a small design modification for functionality, or as complex as creating a start-up company. As physicians, we love to invent and our patients need our ideas. A well thought out design plan is worth its weight in gold.
Thursday, October 14, 2010
Subscribe to:
Post Comments (Atom)
No comments:
Post a Comment