Unbiased Analysis of Today's Healthcare Issues
The value of medical devices caries with it less certainty than pharmaceuticals for a variety of reasons. As described in Kovács et al. (2022) medical devices: often have multiple applications, frequently, undergo product modifications and during their product lifecycle, multiple incremental technological innovations take place affecting both clinical and economic consequences of their adoption into…
Real-world evidence is often used to assess the safety of devices and diagnostics. For instance, the FDA’s , Postmarketing Surveillance Program includes the FDA Adverse Event Reporting System (FAERS); FDA may also require some MedTech companies to conduct Post-Approval Studies. However, as new legislation (e.g., 21st Century Cures Act) has passed and new technology has…
Wearables, digital medicine and ‘beyond-the-pill’ are the latest healthcare craze. New technologies–particular those combined with patients mobile phones–offer the promise of improving patient health. One question is will insurance companies, the government and other payers actually reimburse for these technologies. According to a recent FiercePharma article, the answer is yes…if there is evidence. Payers say they’re willing…
While we are waiting for the King v. Burwell verdict, which could repeal large sections of Obamacare, the house of representatives has already approved rolling back some ACA provisions. Modern Healthcare reports: Lawmakers postponed final passage of the proposed Protecting Seniors’ Access to Medicare Act despite a majority voting in favor of the bill. The…
The stethoscope has been the icon of medicine for 200 years. Shouldn’t we be able to have built a better device by now? In fact, an improved stethoscope exists. The Atlantic describes a new technology that combines a stethoscope and smartphone technology. The CardioSleeve, a new, FDA-approved accessory, transforms a standard analog stethoscope into a…
How will medical technology (medtech) firms face the challenges of an evolving marketplace? Although the global medtech market is expected to grow 4.5% to $455 billion from 2011 to 2018, there is less growth anticipated in developed countries. Today a review a report from PwC’s Health Research Institute (HRI) that provides some insight. Getting funding Having…