January 27, 2017
While not admitting any wrongdoing, the largest global dietary supplement retailer, GNC Holdings Inc., just handed over $2.25 million to avoid federal prosecution. The allegations indicate that GNC sold a misbranded supplement made by Dallas-based USP Labs. According to the Justice Department, USP Labs was also indicted on charges that they conspired to import ingredients from China using false information. This costly mistake should present a lesson to other supplement manufacturers in strengthening supply chain control.
December 1, 2016
A recent report suggests that empty capsules, either non-gelatin or hard gelatin, are expected to increase in demand for both the pharmaceutical and nutraceutical industry sectors. The global pharmaceuticals industry is expanding, as is the nutraceuticals market. While this growth is good for business, it may also signal the need to strengthen inventory management and the supply chain to ensure manufacturers are able to fulfill orders on time and in budget.
November 4, 2016
Hackers are finding their way into many different digital networks and medical devices are on the radar. Connected devices including drug-infusion pumps, pacemakers and other medical devices have the potential for vulnerabilities, which could be dangerous or fatal for the patients using them. The U.S. Food and Drug Administration (FDA) wants medical device manufacturers to perform risk assessments and expose vulnerabilities and solutions, without concern for compliance or penalties. Patient safety is the bottom line.
October 6, 2016
The healthcare industry is facing public backlash for two recent controversial price changes, and the damage could be worsened depending on who makes it to the White House. After Turing Pharmaceuticals and Mylan increased the costs for their respective products, Daraprim and the Epi-Pen, the public was outraged. With this scandalous price gouging out in the open, pharma must figure out a way to control costs before the government, and the public, insist on legislated price controls.
September 19, 2016
The Food and Drug Administration (FDA) has recently issued guidance for general wellness and health apps. The guidance is focused on a very small part of the market, namely the apps and devices that could cause harm if they don’t work as advertised. Most apps are designed to promote a healthy lifestyle. In other words, while they can improve the health of a patient, they aren’t intended to treat diabetes or heart disease. There is a fine line between what the health app is intended to do and what it claims it can do, and the medical device or app manufacturers must be able to make this fine line very clear.
September 9, 2016
There are tens of millions of Americans with artificial joints, cardiac stents or other implanted medical devices. Many private and nonprofit organizations, including hospital systems, want to capture the unique device identifiers (UDIs) from these implanted devices on insurance forms and in patient records. Not only will this information improve patient safety, the data can also be mined to improve the devices and patient outcomes.
August 26, 2016
Physicians prescribe medications to patients in order to address certain health conditions, illnesses or diseases. However, patients don’t always take their medicine as prescribed which could increase the risk for hospital readmissions, as well as serious health complications. De-identified data about medicine adherence is providing valuable insight to pharma companies and arming physicians with the information needed to increase patient adherence.
August 18, 2016
Startup company, Endotronix, is fighting congestive heart failure (CHF) with a double-punch of hardware and software. This disease, affecting nearly 5.7 million Americans, costs billions in healthcare services, medication and lost productivity. Endotronix is developing a digital sensor to be worn by the patient and monitored by their physician to provide appropriate follow-up when needed, while avoiding repeated hospital admissions.
August 11, 2016
A recent study by OpsClarity suggests life science and healthcare businesses are planning to deploy big data analytics applications with the goal of harnessing real-time data. Quick access to reliable data, and the insights derived from analytics transactions, can improve customer services, detect fraud, and support real-time decision-making.
August 4, 2016
The idea and desire for interoperability in the healthcare setting is often talked about because of the many benefits it can offer; however, it’s such a complicated process that it almost seems impossible. Electronic health records (EHRs) were a major step toward interoperability, but sharing them in accordance with HIPPA privacy requirements and between different IT systems remained difficult. Now, the Secretary of Health and Human Services (HHS) has a roadmap and the support of the private sector.