VIII. Working with TTS in Baltimore

This whole section is no longer applicable as the VA Technology Transfer Program (TTP) no longer does field testing, device evaluation, etc. DJ - 08/23/2006

Perhaps one of the most important aspects of successful technology transfer for rehabilitation devices is the clear demonstration that the device is safe and effective. This can only be done through appropriate clinical testing, particularly field testing under realistic conditions. At the present time, we at Palo Alto do not have a clearly established procedure or method of accomplishing this formidable task. Rather, we usually find ourselves trying to sell one of our products to a manufacturer with only limited experimental data using laboratory prototypes.

But there is a mechanism, procedure, and organization within the VA specifically set up to handle this type of field testing within the VA system. That organization is the VA Technology Transfer Section (TTS) in Baltimore, located at 103 So. Gay Street, Baltimore, MD 21202. It was in fact set up originally to give small manufacturers an opportunity to build a few pre-production prototypes under contract to VA, thereby setting up the necessary tooling and making the first few prototypes at no cost to the company. The procedure involves the following: We can submit a Request for Evaluation (RFE) to obtain funds for awarding a contract to a manufacturer for the construction of several prototypes for field testing at various VA Medical Centers across the country. The contract is awarded out of Palo Alto, but the resulting prototypes are delivered to TTS in Baltimore. Then TTS Baltimore decides upon the test sites, arranges for the testing, oversees the testing, collects and analyzes the data, and issues a final report.

We at Palo Alto have submitted three such RFEs for field testing and evaluation of our prototypes; namely: the Handbike, the Ultrasonic Head-Controlled Wheelchair, and the Desktop Vocational Assistant Robot (DeVAR). The Handbike RFE was submitted in January of 1986, with the final report completed by Baltimore in December of 1991. That product is now on the VAs list of prescribable devices which can be purchased for VA patients upon prescription.

For the Wheelchair evaluation, RFE submitted in June of 1985, the final report was issued in February 1995. The DeVAR RFE was submitted in 1989, and the final report was received in October, 1994. During these field tests, our investigators have worked closely with the staff in Baltimore to furnish assistance in the form of instruction manuals, test protocols, on-site assembly if necessary, and trouble-shooting. This relationship has been successful in a qualitative sense, but the time required from the first submission of the RFE to the final completion of testing and reporting has been, in my opinion, unacceptably long. Therefore, if you are to use the service in Baltimore, you should certainly not put the project or product on hold pending their final report, unless you have no other choice.

In all fairness, it must be noted that the above time frames include the process of awarding a contract to the potential manufacturer. This can be quite time-consuming, particularly if the size of the contract is over $25,000, in which case the contract must be put out on bid, including announcement in the Commerce Business Daily and a certain waiting period, as required by government regulations. However, despite the long time period between RFE submission and final report, the service in Baltimore represents a useful supplement to our operations here in Palo Alto with regard to TT. Here we do the research and development, usually resulting in a laboratory working prototype. In Baltimore, actual field tests are conducted in which the important questions of safety, reliability, ease of use, and user satisfaction can be systematically evaluated. One problem is that such tests should be conducted on a pre-production prototype in order to be useful. And sometimes, a laboratory prototype, even with some in-house testing and redesign, may be a long way from a pre-production prototype. One might well ask, then, whether it would make more sense if the field testing were done by the manufacturer after the final product development is done under a Coop R&D Agreement. Judging from our experience with the three products that we actually submitted to Baltimore TTS, it would appear that the present system is most practical for a very expensive product, such as the robotic workstation. It is in such cases that the manufacturer might actually want to wait until completion of the field tests before making a decision on manufacturing.

In the cases of both the Handbike and the Wheelchair, there were some suggested design changes resulting from the Baltimore evaluation which seemed useful to the manufacturer. Whether a serious manufacturer would have come up with those changes in the natural course of final product design is not known. Of course, it is of considerable use (but not essential) to manufacturers to know whether the VA will be one of their customers, but the answer will be known only when the product either goes on the list of VA prescribable devices or is rejected. It can get on that list either as described above, where the device is tested by Baltimore TTS, or by the manufacturer supplying a production prototype to the group which actually purchases commercially available products for the DVA. That group was formally called the Rehabilitation Technology Assessment Section (RTAS) within the VA Department of Prosthetics, also in Baltimore at the same address. Unfortunately, RTAS was disbanded in October, 1994. But it is significant that Lingraphica, a product developed here at the Center and then developed into a commercial product and marketed by Tolfa Corporation, followed the latter approach, first obtaining FDA approval of the product, and then completing the entire process of VA acceptance in a total time of less than six months.