Stephen B Wilcox is founder of Design Science Consulting, based in Philadelphia, USA.
On June 17, 2013, medical device manufacturers located on and near to the USA’s East Coast will meet in Philadelphia for the 30th Medical Design and Manufacturing (MD&M) East trade show and conference. Some readers were involved in the medical device industry back then, when the first few shows took place in the early to mid 1980s. How well they remember it will vary from one reader to the next. But an industry player who was around at that time has written exclusively for Medical Plastics News —Stephen B Wilcox, founder of Design Science Consulting based in Philadelphia.
Reflecting on 30 years of MD&M East and the next 30 years of medical technology
Regulation: In ‘83, the Medical Device Amendments, which had been passed in 1976, were beginning to be felt. The key changes which they authorised were creating the device class system and requiring premarket approval for the first time. The FDA’s Centre for Devices and Radiological Health (CDRH) formed in 1982 and was beginning to create requirements. Thus, the 30-year period in question goes from the beginnings of premarket regulation to the 1990 Safe Medical Devices Act, which added validation requirements, post market surveillance and the authority to require recalls, up to the 2011 Draft Human Factors Guidance. There’s also a history of usability-related standards for devices. The first was HE 48 (93), then HE 74 (01), then IEC 60601-1-6 (04), then IEC 62366 (07), then HE 75 (10). So the whole landscape has dramatically changed.
Canon: Canon began in 1979, just 4 years before, with the publication of MD&DI. The founder, Van Shears, had the vision of creating a bridge between device manufacturers and the FDA, in light of all the changes that were taking place at the time.
Technology: It’s interesting to note the technology of the era and remember just how different it is now. The first mobile phone was introduced in 1983, the Motorola DnyaTAC 8000x, at a cost of $9,000 in today’s dollars. It weighed 2.5 lb (just over 1 kg) and was only slightly larger than an actual brick. The year 1983 also saw the introduction of Apple’s Lisa computer, the first to offer a graphical user interface, and Atari had a whole work station for computer use with several large units. Microsoft Word was introduced in 1983, along with camcorders, and the music CD.
That same year, the military spun off a civilian version of their Advanced Research Projects Agency Network, or ARPANET, which was the very beginning of the internet. 1983 was also the year that Lotus Software launched its spreadsheet software Lotus 1-2-3. Lotus Software is now part of IBM. Lotus 1-2-3 is widely regarded as playing a pivotal role of the success of the IBM PC in the corporate environment.
Medical devices: In 1983, there was virtually no minimally invasive (MIS) surgery except for a few things that were going on in gynaecology. Implanted pacemakers were physically huge, and there weren’t yet implanted defribrillators. The controls and displays on devices were really primitive by today’s standards. They rarely had even dot-matrix displays—LEDs were the norm. There were all sorts of large workstations for devices that are simple handheld devices today. There were few disposable diagnostic tests, and many fewer disposables.
The next 30 years?: It is always a problem to make predictions. A simple approach is to project out our current trends—for example miniaturisation, more computing power and more interconnectivity. But it’s much harder to anticipate what the new trends will be when we don’t have any precedents to refer to —as the appearance of the internet exemplifies. What are these new disruptive technologies that will appear? Here are some possibilities: small remotely-controlled moving devices (ie drone technology), automated diagnosis and treatment, voice control, remote diagnosis and treatment, laboratory-grown organs, personalised medicine, and gene therapy.