Discoveries/Innovations: What the FDA Says About Medical 3D Printing

A customizable implantable heart valve.

The FDA seeks to clarify the pathways manufacturers must follow to get their 3D-printed devices approved with new regulation regarding design, function, durability, and quality of implantable devices. The FDA is attempting to keep up with a rapidly progressing technology that is changing the way we look at devices from skin grafts, to joint prosthetics, to implantable heart valves.

Because of the seemingly endless list of possibilities for the future of medical 3D printing, FDA Commissioner Scott Gottlieb, MD stresses in a statement, “This technical guidance—categorized as a leap-frog guidance because it helps bridge where we are today with innovations of tomorrow—is only intended to provide the FDA’s initial thoughts on an emerging technology with the understanding that our recommendations are likely to evolve as the technology develops in unexpected ways.” One of the strengths of 3D printing is its ability to provide customizable care, since each device can be printed personally for a patient. This also makes regulation uniquely difficult, and the FDA will be forced to closely monitor the developing technology.

Doctor Docs: Doctors Need CyberDefenses

Eighty-three percent of doctors have experienced a cyberattack in their practice, according to a survey conducted by Accenture and the American Medical Association. Of the 1,300 physicians who participated, 55% indicated that they’re extremely concerned about cyberattacks, and the numbers show that their fear is justified.

Besides interrupting the workflow of a practice, cyberattacks put confidential patient information at risk and can be very difficult to recover from. Phishing, or the attempt to steal personal information, comprised 55% of attacks, which is extremely problematic since at least 85% of doctors believe it is important to share electronic personal information outside of their practice system.

“New research shows that most physicians think that securely exchanging electronic data is important to improve healthcare,” AMA President David Barbe, MD, MHA, noted in a news release. “More support from the government, technology, and medical sectors would help physicians with a proactive cybersecurity defense to better ensure the availability, confidentiality, and integrity of healthcare data.” Currently, it is largely third-party health IT vendors that help physicians recover from an attack.

Brand Beat: Reinventing the Radio Ad

Pfizer and Bristol-Myers Squibb have allied to launch a radio campaign via iHeartRadio that will encourage people with atrial fibrillation not caused by a heart valve problem to talk to their doctor about the risks of stroke. As a result of their recent partnership, iHeartMedia will contribute to awareness with media interviews, social media, radio announcements, and online promotions. Pfizer and BMS have already constructed a website with educational information as well as exclusive music videos of Southside Johnny and the Asbury Jukes from a recent “Tune in to AFib” concert.

Ken Dashow, an iHeartRadio personality who hosted the AFib concert, says he got involved because, “In my more than 30 years of experience in the music industry, I’ve learned that music has a powerful ability to inspire action.”

Therapeutic Talk: New Treatment Possibility for Crohn’s Disease

A research team led by Dr. Gary D. Wu at the University of Pennsylvania has already found that lower than normal levels of a gut bacteria called Proteobacteria are present in those with Crohn’s disease. Now, the team has introduced Escherichia coli, which is genetically altered to promote Proteobacteria growth in the gut of lab mice. This suggests a way to alter gut bacteria in people that may lead to a healthier microbiome.

“Because it’s a single enzyme that is involved in this process, it might be a targetable solution,” says Wu. “The idea would be that we could ‘engineer’ the composition of the microbiota in some way that lacks this particular [enzyme].” The team will now research treatment options using this knowledge.

DC Dispatch: Tinkering with Deadly Germs

Government-funded research regarding the pandemic nature of deadly viruses, particularly bird flu, SARS, and MERS, will again be considered after a string of regulatory pauses lasting since 2011. The deadly viruses in question have the ability to kill thousands, and biologists say they need to make genetic changes to the germs in a lab setting to understand what can cause a pandemic and ready them for this kind of emergency situation.

A voluntary moratorium turned into a mandatory funding pause issued by the White House after scientists admitted they had deliberately made forms of a deadly bird flu that could transmit easily among ferrets. While some virologists said the knowledge gained wasn’t worth making a form of superflu, other scientists worried that this research would be done overseas while legal issues held up the work in the U.S.

Now the Department of Health and Human Services released a new framework for making decisions about funding research that has the potential to create a new pandemic strain. “It is very good news for laboratories interested in understanding the threat of natural pathogens to the human population,” states James Paulson, PhD, researcher at The Scripps Research Institute. While many are skeptical, some scientists are happy to move forward with what they believe to be vital research in readying us for a huge potential threat to humans—even with increased scrutiny of laboratory safety.

FDA Update

Drug Approvals

Aclaris Therapeutics, Inc. received approval of Eskata, the first topical, non-invasive treatment for raised seborrheic keratoses. Eskata can be used on SKs, non-cancerous skin growths that appear on the neck and face, for reduced visibility and scarring.

La Jolla Pharmaceutical Company received approval for Giapreza (angiotensin II) injection for intravenous infusion to increase blood pressure in adults with septic or other distributive shock. It also marked the FDA’s 46th approval of the year, which passes the high of 45 reached in 2015 and sets a new record for the agency in recent history.

Sanofi received approval for its insulin lispro injection Admelog. The short-acting insulin is approved to control blood sugar levels in diabetic patients ages 3 and up with type 1 diabetes mellitus and adults with type 2 diabetes mellitus.

Bristol-Myers Squibb announced data from a phase 2 study of pediatric patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia treated with Sprycel and chemotherapy. Findings reported include a 65% event-free and 91.5% overall survival rates at three years. All patients were under 18 years of age, received daily dosages of Sprycel, and achieved complete remission.

Med Device Approvals

The FDA approved Medinol Ltd.’s EluNIR Ridaforolimus Eluting Coronary Stent System, a drug-coated stent used for the treatment of narrowing or blockages of coronary arteries in adults with coronary artery disease. The coating of ridaforolimus helps supply blood to the heart while the device keeps the coronary artery open and acts as a catheter delivery system. The stent is implanted and left in the artery to continue improved blood flow and the ridaforolimus helps prevent re-narrowing.

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