In October 2014, the US Food and Drug Administration (FDA) held a public workshop to gather feedback from the manufacturing and medical device communities with regards to additive manufacturing. The insights from that workshop eventually led to the FDA guidance on Technical Considerations for Additive Manufactured Medical Devices.
There are many unique and vital questions that medical device engineers need to answer with regards to additive manufacturing. While they are not difficult, it is new work compared to traditional applications.
While the 30-page FDA guidance covers a number of important topics such as biocompatibility, software security, and acceptance testing, there are three key areas of risk and where implementation struggles exist that are worth delving deeper into.
Source: The 3 Key Risks of 3D Printing Medical Devices | Design News
In research published on Thursday, scientists compared Scott Kelly to identical twin Mark Kelly after Scott spent 340 days in orbit on the International Space Station and Mark remained Earth-bound.
Both are now retired as NASA astronauts, and Mark is running for a U.S. Senate seat in Arizona.
Source: Oh, brother! NASA twins study shows how space changes the human body – Reuters
Bernie Sanders’ front-runner status in the Democratic presidential primary promises to activate a vigorous debate about his Medicare for All plan, particularly as some Democrats fret his push to eliminate private health insurance could be politically treacherous for the party.
Source: Bernie Sanders, Beto O’Rourke Set Up for 2020 Healthcare Showdown Over Medicare for All | The Civic Report | US News
Although the European Commission and machine manufacturers sing the praises of digitalization in agriculture, others point to the risk of creating new dependencies for farmers on multinationals. EURACTIV France reports.
“The Commission is quite right to promote these solutions, but we need to seriously pay attention to the details of these proposals,” said Cyrielle Denharitgh, head of agriculture and nutrition at Climate Action Network France.
“Digitalization is a very large concept in which one can find the bad and the good,” said Denharitgh whose umbrella organization brings together environmental NGOs such as Oxfam and WWF.
Source: Digital innovation also creates new risks for farmers – EURACTIV.com
An international collaboration between researchers in the U.S. and Brazil has created a new molecule that stops the progression of heart failure while improving its capacity to pump blood.
The molecule, dubbed SAMβA (selective antagonist of mitofusin 1-β2PKC association), is able to inhibit the interaction between protein kinase C beta 2 (β2PKC) in heart cells and mitofusin 1 (mfn1), which is a crucial element of mitochondria, preventing the mitochondria from producing energy and ultimately weakening the heart’s blood-pumping action.
“This interaction was one of our main findings in this study. Its critical role in the progression of heart failure was previously unknown,” Julio Cesar Batista Ferreira, a professor at the University of São Paulo’s Biomedical Science Institute (ICB-USP) in Brazil and principal investigator for the study, said in a statement.
Source: New Molecule Not Only Halts Heart Failure, But Also Improves Blood Pumping Capacity
When the Human Genome Project began 20 years ago, its consortium of researchers from 20 institutes spent more than $1 billion over 10 years to sequence that first genome’s billions of bases.
Recently, researchers from the Harvard Personal Genome Project sent me my whole genome sequence at a small fraction of the time and cost. They compared my genome to the reference genome generated by the Human Genome Project and found over 3 million small differences, or variants.
I was excited to explore my genome and perhaps find some clues related to the source of my type 1 diabetes and lymphedema, which are sometimes genetic but don’t run in my family.
Yet, based on our collaborative work in the NIST-hosted “Genome in a Bottle” (GIAB) Consortium, I know there are still many challenges both in characterizing the sequence of all of the billions of bases in the human genome, the focus of our work, as well as in understanding what the sequence means.
Out of the more than three million variants found in my genome, fewer than 100 currently have a clear meaning.
Source: Genome in a Bottle: Spelling Out DNA’s ‘Dark’ Sequences | NIST
On March 8, the nonprofit Sunlight Foundation and American Oversight jointly filed suit in U.S. District Court for the District of Columbia to compel HHS to release records on how its Office of Women’s Health quietly removed or obscured fact sheets on such issues as lesbian and bisexual health and low-cost screenings for breast cancer.
“The public has a right to know the motive behind the puzzling, and perhaps troubling, decision to delete public health information,” American Oversight Executive Director Austin Evers said.
Source: Transparency Groups Sue Health and Human Services Over Website Changes – Nextgov
As an uncontrollable wildfire turned the California town of Paradise to ash, air pollution researcher Keith Bein knew he had to act fast: Little is known about toxic chemicals released when a whole town burns and the wind would soon blow away evidence.
It was the second time Bein says he was unable to gather post-wildfire research in a field so new public safety agencies have not yet developed procedures for allowing scientists into restricted areas.
Fires like the one that razed Paradise last November burn thousands of pounds of wiring, plastic pipes and building materials, leaving dangerous chemicals in the air, soil and water. Lead paint, burned asbestos and even melted refrigerators from tens of thousands of households only add to the danger, public health experts say.
Source: As wildfires devour communities, toxic threats emerge | Reuters
Finland’s coalition government resigned on Friday a month ahead of a general election, saying it could not deliver on a healthcare reform package that is widely seen as crucial to securing long-term government finances.
Healthcare systems across much of the developed world have come under increasing stress in recent years as treatment costs soar and people live longer, meaning fewer workers are supporting more pensioners.
Source: Finland’s cabinet quits over failure to deliver healthcare reform | Reuters
Philip Morris International Inc has for years paid manufacturing costs to its Indian partner to make its Marlboro cigarettes, circumventing a nine-year-old government ban on foreign direct investment in the industry, internal company documents reviewed by Reuters showed.
The Indian government in 2010 prohibited foreign direct investment (FDI) in cigarette manufacturing, saying the measure would enhance its efforts to curb smoking.
Restricting foreign investment leaves cigarette manufacturing largely in the hands of domestic players, and is supposed to prevent any foreign-funded expansion.
A year after the government’s decision, Japan Tobacco exited India, citing an “unsustainable business model”.
Source: Exclusive: Philip Morris paid for India manufacturing despite ban on foreign investment – documents | Reuters