AAMI News December 2017

News in Brief

SynDaver Synthetic HumanThe SynDaver Synthetic Human is used primarily for surgical simulation, medical training, and medical device development testing.

Synthetic Cadavers Educate Doctors, Inform Device Manufacturers

In the past, training clinicians and testing out new medical devices required human volunteers—alive or dead. But one Tampa, FL–based company is producing elaborately realistic—but not real—cadavers to simulate the entire human body. These “syndavers” are designed using proprietary materials to simulate the various tissues found in the body.

“We are the only company in the world that makes synthetic cadavers,” said SynDaver Labs founder Christopher Sakezles in a statement. “All other anatomical models on the market are made from plastic or rubber, while ours are made from a proprietary library of more than 100 synthetic human tissues.”

The SynDaver Synthetic Human includes skin with fat and fascia planes; all bones, muscles, tendons, and ligaments; fully articulating joints; a functioning respiratory system; and a complete digestive and urinary tract. The model bleeds, breathes, and even has pupils that dilate when they are exposed to light.

Base models cost about as much as a midsize car. The higher end Synthetic Human Patient runs into six figures.

FDA Qualifies First Medical Device Development Tool

The Food and Drug Administration (FDA) has qualified the first tool under its new Medical Device Development Tool (MDDT) program. After approximately 20 years of use, manufacturers of devices designed to address heart failure will no longer have to justify using the Kansas City Cardiomyopathy Questionnaire in their submissions.

“Use of this tool could expedite the regulatory submission and review process by reducing the number of subjects in clinical trials, saving money, increasing confidence in data quality, and improving review speed and consistency, while maintaining the same level of safety and effectiveness for patients,” the FDA said in a statement.

The FDA released final guidance in August describing how it would qualify an MDDT. Once qualified, these tools can then be used in clinical trials to support device submissions and post approval studies without FDA review staff having to reconfirm the tool’s suitability and utility, according to the agency.

Any tool developer, device manufacturer, healthcare provider, or researcher can submit a proposal for consideration by the FDA. The agency maintains a public list of qualified MDDTs that summarizes the evidence and basis of qualification for each tool.

Tech Entrepreneurs, Lawmakers Champion Business Value of Federal Research Funding

Entrepreneurs from eight technology (six healthcare technology) companies and members of the Senate Competitiveness Caucus called for more federal funding for basic research during a Capitol Hill briefing with other lawmakers. According to speakers at the Oct. 25 event, such funding is not just essential for fueling innovation but also for strengthening the U.S. economy.

“Federal investment in R&D is a lynchpin piece of our competitiveness going forward,” said Sen. Chris Coons (D-DE), co-chair of the Senate Competitiveness Caucus. “Funding fundamental science and having it translate into the marketplace and create jobs is [essential].”

The Science Coalition, a nonprofit representing more than 50 leading American research universities, organized the briefing in the face of decreasing investment in basic research. Coons cited an Information Technology & Innovation Foundation report that showed the United States now ranks 22nd in R&D funding as a share of gross domestic product compared with the rest of the world.

“That’s almost hard to believe,” said Coons, who personally experienced the tough investment environment as a chemistry major, prompting him to switch careers “It sends important signals. If there is not longterm, predictable investment in university-based research, it makes it difficult to attract, train, and motivate, and then to launch businesses in the future.”

Three Named to AAMI Awards Committee

Joe Dysko
Codi Nelson
Priyanka Upendra

The AAMI Awards Committee, which is tasked with selecting the recipients of nine AAMI and AAMI Foundation Awards, has selected a new committee chair and two new members.

Joe Dysko, senior director of clinical engineering and capital services at Dignity Health in Phoenix, AZ, will now chair the committee. Codi Nelson, biomedical department team leader at Iredell Health System in Statesville, NC, and Priyanka Upendra, compliance manager at Intermountain Healthcare based in Salt Lake City, UT, have joined the committee for a two-year term.

The committee is accepting applications for the 2018 awards program until Jan. 19. Nomination forms and guidelines can be found at www.aami.org/awards.

AAMI Adopts New Fiscal Year Calendar

During a special business meeting in November, the AAMI Board of Directors voted to change the timing of AAMI’s fiscal year. Starting in 2018, AAMI’s fiscal year will end on Sept. 30 rather than coinciding with the calendar year.

“Earlier this year, the AAMI leadership team analyzed budget data over a five-year period,” said Steve Campbell, AAMI’s chief operating officer. “That analysis showed that AAMI’s third quarter is far more predictable than the fourth quarter, so having our fiscal year end in September makes a lot of sense.”

To accommodate the changeover, AAMI’s 2018 fiscal year will be shortened to nine months, running from Jan. 1 until Sept. 30.