An updated advisory released by the Department of Homeland Security outlined which models of St. Jude Medical's Merlin@home transmitters are affected by cybervulnerabilities, including those that come with MerlinOnDemand capability and are used in health care facilities. A spokeswoman for St. Jude said the company is updating MerlinOnDemand-enabled devices using a similar software upgrade announced last year to address the Merlin@home vulnerability.
The Trump administration's policies are expected to yield positive results for the medical device and life sciences industries, said those attending a Tech Council of Maryland forum. "I think some of the statements that are being made about faster time to market for products in the medical device and biotechnology areas are encouraging," said Stephen Thau of Morrison and Foerster.
Maryland must fund promising biotech startups to prevent them from moving to other states that offer investment capital, writes Newt Fowler. "Maryland's incredible life sciences research cluster should not be our leading export," he writes.
The FDA's device-monitoring system has fallen short in tracking safety issues with laparoscopic power morcellators, taking 22 years before it alerted the agency to the risk of uterine cancer spread linked to use of the devices, states a report that will be released by the Government Accountability Office. The FDA agrees with the report's findings and "has been taking steps to establish a better system to evaluate device performance in clinical practice," an agency spokeswoman said.
The FDA has released a compilation of 22 case studies of different drugs, devices and vaccines that showed promising midstage trial results but weren't confirmed in late-stage studies. The agency aims to emphasize the importance of maintaining the "gold standard" of large, randomized, controlled trials while industry interest in exploring alternatives to Phase III trials is growing.
The White House has indicated support for a federal "right to try" law that would allow terminally ill patients greater access to experimental medications that haven't been approved by the FDA. Similar measures have been approved in 31 states.
Gov. Larry Hogan is continuing efforts to boost the prospects of tech companies operating in Maryland. Hogan's proposals would provide incentives for tech investors, fund STEM education efforts and eliminate state taxes for firms that create jobs in high-unemployment areas.
The US medical technology industry saw a decline of almost 29,000 in the number of jobs from 2012 to 2015 during the implementation of the 2.3% medical device tax, an AdvaMed report found, citing figures from the US Census Bureau Annual Survey of Manufacturers. "These numbers reveal just how devastating of an impact the device tax had on our industry and underscore the urgent need for permanent repeal," said AdvaMed President and CEO Scott Whitaker.
The US Naval Academy is increasing its focus on cybersecurity training. All midshipmen take at least two classes in computer basics and hacking and also benefit from the academy's proximity to the headquarters of US Cyber Command and the National Security Agency.
Grow your future with The Maryland Tech Council Venture Mentoring Services
As we finished up 2016, our pilot year, we are pleased to report success. From 0 to 15 mentee companies and 50 trained mentors the program achieved its goals for the pilot. Mentee companies are actively engaged with their mentor teams and reports from the mentees indicate a uniform sense of progress. Our goal is to reach 30 mentee companies in service in 2017.
With the expanding interest and participation, we have capacity to continue expanding. We are looking for companies beyond the earliest stages, but still young in the development cycle and in need of practical assistance with growth and scaling issues. We are seeking mentee company candidates that meet the parameters for the program. Prospective mentees generally should have:
1. A "tie" to Maryland; 2. A tech or biotech product or service with proof of concept established in some way; 3. At least one full time employee (presumably, the CEO); 4. A direction towards obtaining "series A investments."
Potential mentees/entrepreneurs whose applications are accepted will have the opportunity to present to potential mentors at a monthly VMS meeting, after which the VMS will facilitate matches with interested mentors. Find more information or apply, here.
I never did anything worth doing by accident, nor did any of my inventions come indirectly through accident, except the phonograph. No, when I have fully decided that a result is worth getting, I go about it, and make trial after trial, until it comes.
Thomas Edison, inventor and businessman
About the Maryland Technology Council
The Maryland Tech Council (MTC) is a collaborative community that is actively engaged in building strong technology and life science industries by supporting the efforts of our individual members. MTC is the largest technology and life science trade association in the state of Maryland providing value to members by giving them a forum to learn, share, and connect. MTC is also the only technology council in Maryland with a full-time presence in Annapolis working year round representing its members' interest and seeks to influence policymakers on issues such as tech, life science, economic development, capital formation, higher education, transportation, workforce, tax climate, and more.
In addition, members of MTC are provided with educational programming taught by industry leaders with a focus on key topics and a variety of opportunities to participate in both large and small events. Members also have access to our Cost Savings Program where they can choose from our list of reputable companies that provide discounts for business services.