Originally published January 1996
Surfing the Internet or going on-line can be more than just a diversion; electronic information sources for the device industry report breaking news as well as pertinent regulatory affairs information. Instead of tracking down information through lengthy correspondence and faxes or wading through reams of report pages, as was once necessary, device industry personnel can now access current news almost instantaneously through on-line resources. Most services update daily and cull their information from a range of sources far wider than the average person alone could process, including FDA reports, government legislation, federal regulations, and corporate press releases. These services range in cost from expensive to free and generally require no more than a computer and modem to access.
Representative of the on-line proprietary services available are MDI Online and DeviceNet, two subscription services; a notable free service is the Regulatory Affairs Information Home Page, located on the Internet's World-Wide Web. Each provides useful industry, government, and regulatory affairs information. The proprietary services summarize information from many sources and update daily; the home page informs through links to other primary-source home pages. All can be accessed by IBM or Macintosh platforms.
The MDI Online package by Medical Data International, Inc. (MDI; Irvine, CA), offers access to industry news from several different sources. Three MDI publications, MedPro Month, Competitive Insight, and Inside Surgery, are available on the service. In addition, a daily on-line newsletter, Medical Industry Today, provides breaking industry news. "Medical Industry Today provides anywhere from 30 to 40 breaking stories each day geared toward the device, diagnostics, supply, and equipment industries," says Kevin Hicks, director of information technologies for MDI. "It's always up-to-the-minute, published each morning electronically."
In addition, the MDI Newsroom offers 22 different publications on-line, including Applied Genetics News, Health Legislation and Regulation, and Membrane & Separation Technology News. It also provides a federal news service with "same-day verbatim" transcripts of presidential statements; White House, state, and defense briefings; major congressional hearings; speeches, statements, and press conferences by leading policymakers and newsmakers; and appearances by major figures on television news shows, all transmitted within one or two hours of the event.
Subscribers can also access Internet newsgroups, arenas for discussion of various industry-related topics. "We have an easy-to-use front end, so someone who's not Internet savvy can easily use our system to send messages from the system into the Internet newsgroups," notes Hicks.
The basic service costs $4400 per year for unlimited use by one subscriber. However, the dial-up number is in the 714 area code, which will result in long-distance charges for nonlocal users. Subscribers will be able to log into MDI Online through local providers by the first quarter of next year.
The service requires a computer with a minimum of 4 MByte of RAM, 8 MByte of available storage on the hard drive, and a 9600-baud modem; Windows-based computers should have a cpu of 386 or better and a VGA monitor; Macintosh systems should be 7.0 or higher. For more information on MDI Online call Raymond Hecker, business development manager, at 714/251-2739 or send E-mail to [email protected].
DeviceNet, by Schiff & Co. (West Caldwell, NJ), also provides device industry and regulatory news, updated daily. The package divides the information into industry news, Federal Register, 510(k) listings, warning letters, and FDA enforcement reports. All of the data can be downloaded or searched.
All information presented by DeviceNet is filtered daily from various news wires, FDA sources, and DeviceNet staff research. "The regulatory information comes directly from FDA. Nine times out of 10 we will have it on our system before it's available in print," says DeviceNet's designer and programmer Jack Parker, vice president of the food and cosmetic division of Schiff.
"We will not just take a press release off the wire and send it through. There is a screening process. We encapsulate the news, so if there is a press release that's two or three pages long, you generally will get no more than a headline and a paragraph of the distilled information."
The system was originally designed for use by regulatory affairs staff in the industry. "I quickly found out that, although lots of regulatory affairs people are on the service, we get at least as many R&D, sales and marketing, and executive users," says Parker.
Potential subscribers may test DeviceNet free for 30 days, dialing up with either Schiff's software, SchiffCom (IBM format only), or with any communications software (Mac or PC).
The system can function with any modem speed above 300 baud and can be accessed by any communications software. Schiff will offer a World-Wide Web version soon. For more information on DeviceNet, call 201/ 227-1830 or send E-mail to [email protected] aol.com.
DeviceNet costs $595 per year plus possible long-distance phone charges on the access number. Parker says that not having a toll-free access number keeps the cost of the service down. "We looked at what competitive print information and electronic sources cost, and we priced DeviceNet at generally less than half."
Free regulatory affairs information is available on the Regulatory Affairs Information Home Page on the Internet's World-Wide Web. Don Kafader put the page up last February as an extension of his work as manager of regulatory affairs at Organon Teknika Corp. (Durham, NC) and as a consultant. The page contains links to more than 400 different sites and documents that relate to regulatory affairs, including FDA sites. Kafader maintains and updates the site himself. "I have a personal interest in making information available. The agencies and the guidelines exist, and this is a perfect vehicle to extend that to, basically, the world," he says.
Kafader gathers information for his site from feedback of visitors to it and from monitoring Internet newsgroups. He also checks the various web search engines, such as Yahoo and Web Crawler, for new sites. "Whenever I become aware of a site there's nothing really that prevents me from having a link there 30 minutes later if I am so inclined," says Kafader. "Hopefully I am very current."
The linked sites include information from the Federal Register, U.S. legislation, the Code of Federal Regulations, professional organizations, and consulting organizations. There were about 600 hits, or visits, to the home page itself during the week of November 12, 1995. In the same week, however, there were over 1000 hits to the Federal Register page, which can be accessed through the home page. "That is the page that has been getting the most activity consistently for the last three or four months," adds Kafader.
The home page address is http://www. nando.net/ads/ckbus/RAinfo/reglink1.htm. Kafader also maintains a bulletin board system (BBS), the Regulatory Forum BBS, which can be accessed at 919/848-9461.
Gathering information through on-line services is efficient in terms of time and energy saved; it is also a paperless process. These services are the equivalent of the daily newspapers, with the added advantages of continuous updates, instantaneous transmission, and the ability to search out specific information. They act as a personal research assistant, in some cases at considerably less cost than that of hiring a staff researcher. As activity on the World-Wide Web increases, more resources will appear, making it easier to stay up-to-date on industry happenings--and, perhaps, challenging proprietary services to stay one step ahead of the free ones.--Sashi Sabaratnam