Year 2007 marks the 30th year of this publication’s analysis of U.S. and international med-tech, with Biomedical Business & Technology having issues of our predecessor newsletter beginning from 1983.
To highlight what has or has not changed in this industry, we here provide excerpts of news items from these earlier publications.
August 1983 —
Physiological Devices Revitalizing the Industry
Following six months of declining implant rates and disappointing revenue growth, despite lingering investigations into pacemaker sales practices and mounting uncertainty about reimbursement, the cardiac pacing industry’s momentum is on the increase again. One major reason is the availability of advanced physiological dual-chambered (DDD) pacemakers. These devices ha ve created an intense interest among cardiologists and other pacing specialists—generating enthusiasm not experienced since ventricular demand units started to replace “fixed rate” devices about 15 years ago. DDD units sense and pace in both the upper and lower chambers of the heart establishing a contraction sequence similar to that of the healthy heart, thereby increasing cardiac output up to 20% over the traditional demand units....
Adversely affecting the pacemaker industry is publicity alleging (1) overuse (e.g., the meanwhile discredited Nader report); (2) improper sales practices by certain manufacturers (the ongoing FBI investigation in the U.S. may result in several indictments); the possible negative impact of new reimbursement policies on the number of implants and price levels; and (4) the introduction of new legislative proposals to cut the amount MEDICARE... will pay for pacemakers, their implantation and follow-up services....
An important product development factor in future net growth will be devices capable of terminating and/or preventing potentially dangerous arrhythmias that do not respond to drug treatment.
Forces That Will Shape The Market
In its nearly completed multi-client study, “Opportunities in the Commercial Development of NMR Imaging,” there is no question that Nuclear Magnetic Resonance (NMR) imaging is one of the most significant developments in modern medicine, both for its promised contributions to accurate, safe and painless medical diagnosis, and for the market opportunity it offers. As one measure of interest, the Society of Magnetic Resonance in Medicine (SMRM) in 1981 drew about 300 participants....” Clearly, a great deal is expected of NMR, and although the latest conference showed that this modality can fulfill many of the technological expectations (resolution comparable to CT, reduced imaging time, rapid reconstruction, spectroscopic measurements, nonproton imaging), a great deal remains to be explored before its place in medicine and commerce will be ....
ADVANCES IN ARTIFICIAL ORGANS
Helped by a less restrictive regulatory environment and excellent cooperation between manufacturers, universities and government technology agencies, Japan is making rapid gains in artificial organ development....
A totally implantable artificial middle ear consisting of a microphone, amplifier, vibrator and power supply, weighing 16 gms only, will enter human clinical trials this fall. Developed by RION and SANYO ELECTRIC, the device directly vibrates the inner ear lymph, bypassing the tympanic nic substance....
Blood vessels made of porous Teflon are currently tested by Japan’s INSTITUTE OF PHYSICAL & CHEMICAL RESEARCH. Porosity is achieved by stretching the Teflon material, while heating it close to its melting point; the vessel then is coated with an anti-thrombogenic substance.
Japan is leading in the development of artificial blood. Pioneer Green Cross reported success in vitro tests with an oxygen transporting plasma extender which can be stored at normal temperature: two years at 10 degrees C; one month above 30 degrees C.
U. S. DEVELOPMENTS
Health Maintenance Organizations, providers of reduced cost health insurance plans, expect their membership to increase from a current 5.5% of the U.S. population to 14% by 1990.”