In Part 1 of this blog, we discussed disruptive technology as it pertains to the medical equipment market. Due to the high cost of leading-edge medical technology, sales are lagging for the most cutting-edge systems, such as hybrid x-rays, which combine radiology/cardiology interventional x-ray systems.
Any time a disruptive technology comes along, prior generations of similar technologies are impacted. In the consumer market, customers generally adopt new technology rapidly if the price is right. For higher-value equipment, though, prior generations may find a new lease on life while customers wait until new technology price points come down.
The European Center for the Validation of Alternative Methods performed a validation for in vitro irritation test for cosmetics and chemicals to replace the rabbit irritation test. Nelson Laboratories is participating in a round robin study to see if the validation will apply to medical devices in a three-phase process.
Over 200 million people have downloaded a healthcare application to their smartphone. However, only a small number of those downloaded apps are used regularly and, since most apps are free, even a smaller number of applications actually generate any revenue.
In a draft guidance document, FDA has placed its summary of ideas regarding biocompatibility and possible changes that could eventually replace FDA G-95 Blue Book Memorandum #G95-1 on biocompatibility. The draft document has been out since April and is widely available, though it has not been formally released.
In today’s interconnected world, it’s easier to set a DVR from an airplane seat or remotely watch the kids arrive home than to gather significant data about our health. Traditional office visits, laboratory tests, and hospital-based equipment are still the primary means of acquiring information about a person’s health.
In order to reduce unneeded animal testing and possible cost and duration of testing, the ISO 10993 committee is looking to add an in vitro option to irritation testing. For the past 20 years, if you wanted to test for irritation, you had to do a version of the animal irritation test.
Anyone who has ever been in an OR with a surgeon will know that pleasing them with your new device is no mean feat! So should we be looking at surgical innovation in a different way? Is industry completely misaligned to the needs of the surgeon and should we be looking to our surgeon customers to drive our approach to innovation?
Intellectual property has become an increasingly hot topic recently in the medical and biotechnology field. Recently, the Supreme Court upheld non-naturally occurring DNA as being patent eligible in Association for Molecular Pathology v. Myriad Genetics.
Making sure patient information is secure begins with coding on the package. No matter to whom the medical device is targeted—for a specific patient, hospital, or doctor—the coding placed on the package is the first part of the data set used to track the device.
While the adoption of electronic health records helps healthcare facilities streamline data collection and retention, it also presents challenges when it comes to security. Traditional paper file storage in healthcare facilities is being replaced by computers and portable electronic devices that are often more exposed to threats.
The inherent insecurity of many medical devices was highlighted in a recent FDA and Homeland Security alert. Over 300 devices have been identified that utilize a hard code password, creating a huge security loophole. With so many medical devices now collecting and storing patient data, this raises the question of how secure is the data stored on these devices?
Guy Francfort, vice president of sales and marketing for MEGA Electronics Inc., was a part of the staff written article, “Portability Is the Name of the Game.” He took time to present a full array of responses that were not able to be included in the article, so they are presented here.
Mel Berman, former product marketing manager (now retired) for TDK-Lambda Americas, was a part of the staff written article, “Portability Is the Name of the Game.” He took time to present a full array of responses that were not able to be included in the article, so they are presented here.
The real challenge facing life science companies is that meeting these extensive regulatory and quality procedures, codified in cGMP [current good manufacturing practices] regulations burdens companies, delays product rollouts, impedes innovation, and hinders business processes.