While it’s been a mild winter here in New England, winter weather is in the forecast for this weekend. When winter snowstorms hit, it’s a good idea to make sure that your laboratory is prepared to handle the consequences of inclement weather. As many of us know, snowstorms can result in power and WiFi outages. […]

At the recent GAMP Forum sponsored by the ISPE Boston Area Chapter, multiple presenters from across the US, all active members of the ISPE GAMP Community of Practice (COP), met  to discuss computer system validation (CSV) or Computer Software Assurance (CSA). First, a bit of background: As the regulated medical device and drug industry struggles […]

FDA continues to encourage the use of innovative new technologies to support the development of quality new drugs and ensure that patient safety is uppermost in the development and manufacture of drugs. As Scott Gottleib noted when discussing medical devices, FDA wishes to encourage device manufacturers to “make investments to re-tool their manufacturing processes” to […]

On Friday November 1st Boston University Questrom School of Business is hosting a Health and Life Sciences Conference. The topic of this Fall Conference is “Disruption in the Face of Limitation.” Panelists and speakers discuss innovation in an era of consumerism and cost sensitivity. Panel discussion topics include Pharmaceutical Pricing, Medicare and Medicaid, Digital Health, […]

Pharmaceutical, biological and medical device products require controlled environmental storage conditions. Degradation can occur when the storage environment of the product exceeds the range of safe conditions of the product. For example, some pharmaceutical materials need to be stored at ambient temperature to preserve the potency of the product. If the temperature of the storage […]

On Wednesday, July 31 from 5:30 to 8:30 PM, MDG Boston will host their 13th annual “Transitioning Into and Within the Medical Device Industry” networking event at Regis College in Weston.  Historically, this is the most popular MDG Boston networking event of the year, ideal for anyone looking to enter or move laterally within the […]

The pressure to drive costs down drives the incentive to innovate up for the MedTech Entrepreneur. On Wednesday, April 17, from 5:30 – 8:30 PM, MDG Boston will host the forum “US Healthcare Economics – Innovating Our Way Out of a Crisis” at Regis College in Weston, MA. This discussion is essential for MedTech developers […]

Novel therapeutics are revolutionizing the treatment of diseases like cancer, neurological disorders such as Alzheimer’s and multiple sclerosis, and various genetically inherited conditions. Research demonstrates that advances in novel therapeutics modalities can carry out complex functions in ways that traditional drugs cannot achieve. Many pharmaceutical companies are at the frontier of this next generation of […]

Would you like to know more about the emerging field of tissue and organ manufacturing?  Then mark your calendar for April 4th when the Advanced Regenerative Manufacturing Institute (ARMI) will describe the progress it has made since its 2017 launch. Remarks from AMRI leaders Dean Kamen and Dr. Thomas Bollenbach, as well as NH Commissioner […]

Join MDG Boston for a forum on “Medical Imaging and Diagnostic Innovations – What’s New In Imaging” at Regis College in Weston, MA on Wednesday, March 6 from 5:30 to 8:30 PM. Advances in medical imaging reduce the need for some surgeries, reduce false negatives and reduce the total cost of care. Mammography has dramatically […]