Showing: 1 - 4 of 4 RESULTS

3D metal printer at College of Dental Medicine expands possibilities for innovation

IMAGE

IMAGE: The component that Renne was able to print for the ZIAN team.
view more 

Credit: MUSC

When the Zucker Institute for Applied Neurosciences at the Medical University of South Carolina needed to bring to life a neurosurgeon’s idea for better instrumentation for sacroiliac surgery, there was one obvious partner to turn to: the MUSC College of Dental Medicine.

The college is the only dental program in the nation to have the Sisma Mysint100 3D selective laser fusion printer that creates 3D prints from metal rather than plastic, and Walter Renne, D.M.D., a professor in the Department of Oral Rehabilitation and assistant dean of innovation and digital dentistry, is eager to see what it can do.

“3D printing is how we get stuff from our imagination into reality. One of the issues in the past was most of what we could print was plastic, and plastic degrades. You need something to actually function,” he said. “Now, instead of imagining something and developing a plastic prototype that I can look at, I can imagine something and develop a real, usable final product that can be put into a drill or placed in a patient’s mouth. It’s really exciting to have that at the university.”

The manufacturer, Sisma, donated the printer about six months ago. Renne said Sisma wanted its latest device to find a home in a college that would think up creative and innovative uses for it. Those uses aren’t limited to dentistry, however.

The college and ZIAN have collaborated in the past, so it was natural for ZIAN to turn to Renne and colleagues for help with this project, which started with an idea from Stephen Kalhorn, M.D., a professor in the Department of Neurosurgery.

Kalhorn has worked several times before with ZIAN, a technology accelerator that exists to help MUSC’s medical providers to develop their ideas for new devices or device improvements.

“I run things by them because then I can spend the majority of my time in the operating room actively helping patients,” he said. “I can literally drop off a napkin sketch at a ZIAN engineer’s desk or even less than that. There’s even been times that I’ve just drawn on the dry-erase board in the OR and taken a picture and sent it to them, and they’re off to the races.”

This time, Kalhorn had an idea to improve sacroiliac joint fusion surgery. The sacroiliac joint is where the pelvis and spine meet; it is also a source of lower back pain. Fusion surgery encourages the two bones to grow together into one so there is no wiggle room between the two.

Bony fusion requires three elements, Kalhorn explained: stabilization, such as when a cast is placed on a broken limb; decortication, which is the removal of the top layer of tissue to ensure there’s no cartilage or fibrous material blocking the bone cells from building a bridge between the two bones; and compression, whereby the pressure encourages more bone growth. But nothing on the

The Medical Device Innovation Consortium (MDIC) Announces Case for Quality Collaborative Community with FDA Participation

The Medical Device Innovation Consortium (MDIC) announced today that the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) will participate in its Case for Quality Collaborative Community (CfQcc) initiative.

The CDRH identified participation in collaborative communities as a strategic priority for 2018 to 2020. The purpose of a collaborative community is to bring together medical device stakeholders in a continuing forum of private- and public-sector members, including the FDA, to achieve common outcomes, solve shared challenges, and leverage collective opportunities. Ultimately, collaborative communities seek to contribute to the improvement of areas affecting U.S. patients and healthcare.

“The FDA is committed to working with diverse stakeholders to help ensure that patients and health care providers have access to safe, effective, and high-quality medical devices,” said Francisco Vicenty, CfQcc program manager within FDA’s CDRH. “Today’s announcement reflects the agency’s commitment to collaborative communities and builds upon existing efforts to help advance medical device quality and safety to achieve better patient outcomes. We continue to believe that collaborative communities can contribute to improvements in areas affecting patients and health care in the United States.”

The mission of the CfQcc is to convene a collaborative community of diverse stakeholders representing and serving the medical device industry with the goal of transitioning from baseline regulatory compliance to sustained, predictive practices that advance medical device quality and safety to achieve better patient outcomes. As the Convener of the CfQcc, MDIC will facilitate a neutral environment of trust and transparency, wherein a diverse group of stakeholders representing the breadth of the medical device ecosystem can collaborate openly with candor irrespective of whether they are a manufacturer, provider, patient, payor, or a member of MDIC. This initiative builds on the progress of MDIC’s Case for Quality program.

“We founded the vision and mission of the Case for Quality to reduce the risk to patients. The transformation of Case for Quality from an ecosystem program to a collaborative community really is an exciting time for us,” said Joe Sapiente, Vice President of Quality Assurance and Regulatory Affairs, Surgical, Breast, Skeletal Health, for Hologic Inc. and Chair of MDIC’s Case for Quality Steering Committee. “The formation of the Case for Quality Collaborative Community is a model for long-term success and benefit, in terms of governance, agency and industry involvement, and relationship management of our diverse stakeholders.”

In 2019, MDIC’s National Evaluation System for health Technologies Coordinating Center (NESTcc) Collaborative Community was named one of the first collaborative communities with FDA participation.

About the Medical Device Innovation Consortium
Founded in 2012, the Medical Device Innovation Consortium (MDIC) is the first public-private partnership created with the sole objective of advancing medical device regulatory science throughout the total product life cycle. MDIC’s mission is to promote public health through science and technology and to enhance trust and confidence among stakeholders. MDIC works in the pre-competitive space to facilitate the development of methods, tools, and approaches that enhance understanding and improve evaluation of product safety, quality, and

The Medical Device Innovation Consortium (MDIC) Announces New Vice President of Health Economics and Patient Value

The Medical Device Innovation Consortium (MDIC) announced today that Jo Carol Hiatt, MD, MBA, has joined the organization as Vice President of Health Economics and Patient Value (HEPV). In this role, Dr. Hiatt will facilitate efforts among the Consortium, CMS, private payers and patient advocacy groups to empower medical device companies to better understand the evidence they will need to support efficient CMS review, with the ultimate aim of increasing patient access to innovative medical devices and reducing the cost associated with commercializing these technologies. She joins MDIC following her most recent tenure leading teams to review new technologies to inform evidence-based clinical technology options for Kaiser Permanente, one of America’s leading health care providers and nonprofit health plans. She is a general surgeon and partner emeritus with the Southern California Permanente Medical Group (SCPMG).

“We are looking forward to having Jo Carol join the MDIC team,” said Pamela Goldberg, President and CEO of MDIC. “Not only does she have expertise in how technology adoption decisions are made from the payor perspective, but she also has clinical experience helping patients navigate decision-making processes about their treatment options.”

Dr. Hiatt brings 30+ years of experience working both directly with patients and from the administrative perspective to improve their access to innovative medical care. She has worked closely with FDA, researchers, clinicians, policymakers, and other stakeholders to review and assess health technologies for both public and private coverage. She was a member of the FDA Payor Communication Task Force, former chair of the EXCITE International Payor Advisory Committee, and held advisory roles on various other boards and committees. She served on the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) advising the Administrator of the Centers for Medicare & Medicaid Services (CMS) concerning the adequacy of scientific evidence available to CMS for “reasonable and necessary” determinations under Medicare.

“I am very excited to accept this opportunity supporting MDIC’s efforts accelerating patient access to technologies shown to improve clinical outcomes. I look forward to joining the team,” said Hiatt.

About the Medical Device Innovation Consortium

Founded in 2012, the Medical Device Innovation Consortium (MDIC) is the first public-private partnership created with the sole objective of advancing medical device regulatory science throughout the total product life cycle. MDIC’s mission is to promote public health through science and technology and to enhance trust and confidence among stakeholders. MDIC works in the pre-competitive space to facilitate the development of methods, tools, and approaches that enhance understanding and improve evaluation of product safety, quality, and effectiveness. Its initiatives aim to improve product safety and patient access to cutting-edge medical technology while reducing cost and time to market. For more information, visit http://www.mdic.org.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201001005183/en/

Contacts

Taylor Jackson
tjackson@mdic.org
+1 202.510.9391

Source Article

Fourth Bioelectronic Medicine Summit Showcases Broad Innovation

MANHASSET, N.Y.–(BUSINESS WIRE)–Sep 28, 2020–

Some of the most influential international experts, researchers, and scientific minds participated in the Fourth Bioelectronic Medicine Summit: Technology Targeting Molecular Mechanisms, hosted by The Feinstein Institutes for Medical Research – the global scientific home of bioelectronic medicine – on September 23 and 24.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200928005523/en/

Drs. Kevin Tracey, Valentin Pavlov, Sangeeta Chavan welcome participants to the 2020 Bioelectronic Medicine Summit (Credit: Feinstein Institutes)

Bioelectronic medicine combines molecular medicine, neuroscience, and biomedical engineering to develop innovative therapies to treat a variety of diseases and conditions through targeted stimulation of nerves, including paralysis, arthritis, pulmonary hypertension, and inflammatory bowel disease. Due to coronavirus disease 2019 (COVID-19), this year’s summit was held virtually and drew nearly 200 attendees, including esteemed academic leaders, members of the media, and industry professionals.

“Even though our recent focus has been on discovering a COVID-19 treatment, we continue to research, invest and lead in bioelectronic medicine,” said Kevin J. Tracey, MD, president and CEO of the Feinstein Institutes. “It was an honor to bring together some of the most influential experts to explore, define, and propel this exciting field of science even further.”

Key highlights from the symposium include:

  • Gene Civillico, PhD, National Institutes of Health, discussed SPARC and the need to openly share data amongst the science community to promote innovation;
  • Chris Puleo, PhD, General Electric, described a non-invasive method of using ultrasound to modify neuromodulation;
  • David Chernoff, MD, SetPoint Medical, explained how research is going from the bench to the bedside in cutting-edge clinical trials to treat autoimmune diseases;
  • Kip Ludwig, PhD, University of Wisconsin, reviewed the steps needed to translate bioelectronic medicine to be used more effectively in humans;
  • Lawrence Steinman, MD, Stanford Medicine, delivered the keynote address discussing amyloid proteins and the neuroimmune regulatory pathway.

“It is exciting to hear, and see first-hand from the people leading progress in bioelectronic medicine,” said Valentin Pavlov, PhD, professor in the Feinstein Institutes’ Institute of Bioelectronic Medicine and co-chair of the summit. “It is important that collectively, researchers from around the globe continue to share their knowledge and help evolve this flourishing and promising field of science.”

Breakthroughs in engineering such as miniature electrodes, flexible sensors, methods of controlling and observing vagus nerve stimulation were among the presentation topics. In addition to video presentations, exhibitions, Q&A sessions, and networking opportunities, more than 23 research poster abstracts were displayed – giving attendees a glimpse into what’s on the horizon for bioelectronic medicine.

“We are at the forefront of a medical and technological revolution,” said Sangeeta Chavan, PhD, professor in the Feinstein Institutes’ Institute of Bioelectronic Medicine and co-chair of the summit. “These lectures, presentations and open-dialogue conversations strengthen our view that bioelectronic medicine will treat the world’s most complex disorders, potentially even better than pharmacologics.”


About the Feinstein Institutes


The Feinstein Institutes for Medical Research

is the research arm of Northwell Health, the largest health care provider and private employer in New