One day, I envision that there will be medical technology that can exceed the capabilities of the human body’s natural physiology. Should someone with such a device be prevented from playing professional sports due to the competitive advantage it provides?
Scores of medical manufacturing professionals have contacted Teknor Apex Company in the few days since we announced the results of a study we conducted on the effects of plasticizer migration on non-PVC device components that come into contact with components made of PVC.
Medical professionals can agree that protecting patient information is one of their top priorities. Patients put a lot of trust into their healthcare providers to maintain that their information is never lost or stolen, and providers are subject to rigorous standards, such as the Health Insurance Portability and Accountability Act (HIPAA).
Data security is a hot topic in the healthcare industry. Healthcare network providers have the difficult task of identifying the correct technology to collect and store data all while maintaining a secure network to communicate and transmit the data. It is important to not only consider the type of technology healthcare networks utilize to collect data...
The key to protecting PHI data is education, execution, and continuous verification. The first thing is to understand your obligation as a custodian of this sensitive data. This is best done through formal HIPAA/HIPAA-HITECH training to understand the regulation.
Research and development is the cornerstone of growth in the medical device industry. R&D funding is available; however, the issue isn’t availability as much as availability for marginal improvement. The question to ask is, “Will a marginal improvement reduce costs for the patient and caregiver?”
I can be a kid at heart. And when I say that, I state it with an almost literal meaning. I still enjoy toys. Now, I’m not the 40-year-old virgin character from the movie of the same name, but I can’t admit to not still tinkering with Lego bricks and finding enjoyment from it.
We see funding for new medical devices driven by private investment from individuals or private companies. These bold investors are capable of quick decisions as they meter the funding to match progress and discover the real market opportunity.
The buzz around wearable technology has been escalating the past several months. In fact, wearable technology has moved beyond product concepts to actual products worn by consumers. These include virtual reality eyeglasses, sophisticated health monitoring devices housed within an elastic wristband, sensor-based canes for the blind, and smartwatches with many features.
The financial pressures medical device OEMs are facing are very real. They’re experiencing reduced reimbursements from the government and insurance companies, increased taxes, and global competition. As a result, new business models are evolving to ensure new product innovation is not stifled and, most importantly, patient safety is not compromised.
While Metrigraphics LLC certainly does not speak for the medical device OEM industry, as a custom contract manufacturer of leading edge micro components, we certainly feel the impacts of various external elements on the ebb and flow of R&D and innovation activities of the OEMs.
As OEM’s streamline to meet financial pressures, top level designs will be emphasized but second and third level particulars will adhere more closely to a suppliers understanding of their present capability. The particulars are under a fine balancing act and vision outside will require a thorough knowledge, down to the step-by-step production process to lean out waste.
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.