Program leverages ISACA’s Medical Device Discovery Appraisal Program (MDDAP) to enhance device quality and patient safety.
The United States Food and Drug Administration (FDA), Medical Device Innovation Consortium (MDIC), ISACA, and medical device industry stakeholders developed the Case for Quality Voluntary Improvement Program (VIP) to shift the mindset of medical device manufacturers beyond regulatory compliance and toward continuous improvement. After a pilot launch in January 2018, the Case for Quality Collaborative Community has now transitioned the VIP from a pilot into a fully operational program.
The VIP leverages ISACA’s Medical Device Discovery Appraisal Program (MDDAP) which provides a model and method by which device makers can measure their capability to produce high-quality devices with the goal to improve patient outcomes. The MDDAP framework is a version of the ISACA Capability Maturity Model Integration (CMMI) that has been tailored specifically for this medical device industry program.
The VIP includes a multi-pronged approach: a combination of annual MDDAP appraisals against a set of best practices, quarterly check points with performance reports, and a supportive regulatory environment. Together, this approach empowers medical device manufacturers to design, build, and deliver safe and innovative products to market faster.
In the VIP, an experienced appraisal team evaluates an organization’s capabilities through conversations with individual contributors, systems demonstrations, and site tours. The results are then synthesized for the organization to easily identify areas of strength to reinforce and prioritize opportunities for improvement.
The VIP is a continuous improvement method designed to help the Collaborative Community understand how to develop better quality and outcomes, both within an organization and across industry. Information is collected during an appraisal to evaluate how work is actually performed, highlight capabilities and activities that add value, and drive discussions that align and prioritize opportunities with business performance objectives.
In the supportive regulatory environment, participants were able to accelerate device improvement and speed to market. Results reported by pilot participants include:
The fully operational program has formalized the collaborative oversight used through the pilot into an official Governing Committee which includes members of MDIC, FDA, and industry, with ISACA and relevant collaborators serving as advisors. Iterative improvements and enhancements for the program are proposed through facilitated VIP working groups. This governance structure engages all stakeholders in seeking beneficial solutions through the sharing of information and ideas.
“We are excited that the VIP, which utilizes ISACA’s MDDAP, is now transitioning to a fully operational program. This allows better medical devices to be innovated faster and at lower costs,” says Nader Qaimari, ISACA chief product officer. “ISACA is proud to have a hand in driving sustainable improvements for medical device quality, in turn offering better patient safety outcomes.”
3D-printed sensors allow for simultaneous recording and imaging of tissues and organs during surgical procedures.
A research team from Los Alamos National Laboratory and Purdue University have developed bio-inks for biosensors that could help localize critical regions in tissues and organs during surgical operations.
"The ink used in the biosensors is biocompatible and provides a user-friendly design with excellent workable time frames of more than one day," said Kwan-Soo Lee, of Los Alamos' Chemical Diagnostics and Engineering group.
The new biosensors allow for simultaneous recording and imaging of tissues and organs during surgical procedures.
"Simultaneous recording and imaging could be useful during heart surgery in localizing critical regions and guiding surgical interventions such as a procedure for restoring normal heart rhythms," said Chi Hwan Lee, the Leslie A. Geddes Assistant Professor of Biomedical Engineering and Assistant Professor of Mechanical Engineering and, by courtesy, of Materials Engineering at Purdue University.
Los Alamos was responsible for formulating and synthesizing the bio-inks, with the goal of creating create an ultra-soft, thin and stretchable material for biosensors that is capable of seamlessly interfacing with the surface of organs. They did this using 3D-printing techniques.
"Silicone materials are liquid and flow like honey, which is why it is very challenging to 3D-print without sagging and flowing issues during printing," Kwan-Soo Lee said. "It is very exciting to have found a way to create printed inks that do not have any shape deformation during the curing process."
The bio-inks are softer than tissue, stretch without experiencing sensor degradation, and have reliable natural adhesion to the wet surface of organs without needing additional adhesives.
Craig Goergen, the Leslie A. Geddes Associate Professor of Biomedical Engineering at Purdue University, aided with the in vivo assessment of the patch via testing in both mice and pigs. The results showed the biosensor was able to reliably measure electrical signal while not impairing cardiac function.
The research was published today in Nature Communications. It was funded by Science Campaign 2.
Flexible electronics promise bendable, shapeable, yet energy-efficient computer circuits that can be worn on or implanted in the human body to perform myriad health-related tasks.
Ultrathin, flexible computer circuits have been an engineering goal for years, but technical hurdles have prevented the degree of miniaturization necessary to achieve high performance. Now, researchers at Stanford University have invented a manufacturing technique that yields flexible, atomically thin transistors less than 100 nanometers in length – several times smaller than previously possible. The technique is detailed in a paper published June 17 in Nature Electronics.
With the advance, said the researchers, so-called "flextronics" move closer to reality. Flexible electronics promise bendable, shapeable, yet energy-efficient computer circuits that can be worn on or implanted in the human body to perform myriad health-related tasks. What's more, the coming "internet of things," in which almost every device in our lives is integrated and interconnected with flexible electronics, should similarly benefit from flextronics.
Technical difficulties Among suitable materials for flexible electronics, two-dimensional (2D) semiconductors have shown promise because of their excellent mechanical and electrical properties, even at the nanoscale, making them better candidates than conventional silicon or organic materials.
The engineering challenge to date has been that forming these almost impossibly thin devices requires a process that is far too heat-intensive for the flexible plastic substrates. These flexible materials would simply melt and decompose in the production process.
The solution, according to Eric Pop, a professor of electrical engineering at Stanford, and Alwin Daus, a postdoctoral scholar in Pop's lab, who developed the technique, is to do it in steps, starting with a base substrate that is anything but flexible.
Atop a solid slab of silicon coated with glass, Pop and Daus form an atomically thin film of the 2D semiconductor molybdenum disulfide (MoS2) overlaid with small nano-patterned gold electrodes. Because this step is performed on the conventional silicon substrate, the nanoscale transistor dimensions can be patterned with existing advanced patterning techniques, achieving a resolution otherwise impossible on flexible plastic substrates.
The layering technique, known as chemical vapor deposition (CVD), grows a film of MoS2 one layer of atoms at a time. The resulting film is just three atoms thick, but requires temperatures reaching 850 C (over 1500 F) to work. By comparison, the flexible substrate - made of polyimide, a thin plastic - would long ago have lost its shape somewhere around 360 C (680 F), and completely decomposed at higher temperatures.
By first patterning and forming these critical parts on rigid silicon and allowing them to cool, the Stanford researchers can apply the flexible material without damage. With a simple bath in deionized water, the entire device stack peels back, now fully transferred to the flexible polyimide.
After few additional fabrication steps, the results are flexible transistors capable of several times higher performance than any produced before with atomically thin semiconductors. The researchers said that while entire circuits could be built and then transferred to the flexible material, certain complications with subsequent layers make these additional steps easier after transfer.
"In the end, the entire structure is just 5 microns thick, including the flexible polyimide," said Pop, who is senior author of the paper. "That's about ten times thinner than a human hair."
While the technical achievement in producing nanoscale transistors on a flexible material is notable in its own right, the researchers also described their devices as "high performance," which in this context means that they are able to handle high electrical currents while operating at low voltage, as required for low power consumption.
"This downscaling has several benefits," said Daus, who is first author of the paper. "You can fit more transistors in a given footprint, of course, but you can also have higher currents at lower voltage - high speed with less power consumption."
Meanwhile, the gold metal contacts dissipate and spread the heat generated by the transistors while in use - heat which might otherwise jeopardize the flexible polyimide.
Promising future With a prototype and patent application complete, Daus and Pop have moved on to their next challenges of refining the devices. They have built similar transistors using two other atomically thin semiconductors (MoSe2 and WSe2) to demonstrate the broad applicability of the technique.
Meanwhile, Daus said that he is looking into integrating radio circuitry with the devices, which will allow future variations to communicate wirelessly with the outside world - another large leap toward viability for flextronics, particularly those implanted in the human body or integrated deep within other devices connected to the internet of things.
"This is more than a promising production technique. We've achieved flexibility, density, high performance and low power - all at the same time," Pop said. "This work will hopefully move the technology forward on several levels."
Funding for this research was provided by the Swiss National Science Foundation's Early Postdoc Mobility Fellowship, the Beijing Institute of Collaborative Innovation, the U.S. National Science Foundation and the Stanford SystemX Alliance.
While cutting tool industry sales contracted slightly from March to April, the general trend of recovery appears to be holding in spite of supply chain disruptions.
U.S. cutting tool consumption for April 2021 totaled $170 million, according to the U.S. Cutting Tool Institute (USCTI) and AMT – The Association For Manufacturing Technology. This total, as reported by companies participating in the Cutting Tool Market Report collaboration, was down 4.3% from March's $177.6 million and up 26.3% when compared with the $134.6 million reported for April 2020. With a year-to-date total of $641.9 million, 2021 is down 6.4% when compared to April 2020.
These numbers and all data in this report are based on the totals reported by the companies participating in the CTMR program. The totals here represent the majority of the U.S. market for cutting tools.
According to Bret Tayne, president of USCTI, “While cutting tool industry sales contracted slightly from March to April, the general trend of recovery appears to be holding in spite of supply chain disruptions, the lack of incentive for the workforce to return, and other challenges our manufacturing customers are navigating.”
Costikyan Jarvis, president of Jarvis Cutting Tools, comments, “The April results show significant year-over-year increases, but that is benefiting from being compared to the first of the lockdown months. Unfortunately, the month-over-month results are not as strong. The April results suffered a 4.3% drop from March 2021 and indicate a pause in manufacturing’s return to pre-COVID levels.
“The macro trends are still strong. April’s PMI of 60.7 showed continued expansion, and the University of Michigan’s consumer confidence number of 88.3 remains high. All these point to a strong second half of 2021 and continued strength in 2022. Despite these positive trends, manufacturing is still facing immediate challenges. Commercial aerospace is still weak with no improvement on the near horizon. The chip shortage for automobiles is affecting demand, and finally, there are inflationary pressures being felt. The hiring of staff continues to be a challenge, and section 232 tariffs are still in place.”
Glen Carlson Jr. retired chairman emeritus of Acme Manufacturing Co. passes; Scott Taylor joins MC Machinery’s Consumables Product Group; GWS Tool Group newest Application Specialist, Jack Crawford; Zachary Thomas joins Solar Atmospheres of Western Pennsylvania; Trelleborg’s Linda Muroski named one of Industry Era’s 10 Most Inspiring Women Leaders of 2021
We are extremely pleased to welcome our newest member, Zachary Thomas, to our Solar Atmospheres of Western PA team. Thomas will be assuming the role of outside sales manager reporting directly to our sales director, Mike Johnson.
Thomas is a Pittsburgh native and has an extensive background in the metalworking arena. Thomas has demonstrated a can do attitude that will enhance the relationships established with our current customer base along with new prospective clients.
Thomas states, “I am very excited to join the team at Solar and make an immediate impact in my new role. I appreciate the opportunity to work for such a prestigious company.”
We welcome Thomas to our Solar family!
Glen Carlson Jr. retired chairman emeritus of Acme Manufacturing Co., Auburn Hills, Michigan, USA, passed away on June 14, 2021, after a brief illness. Glen was born in Detroit, Michigan on August 3, 1935. He was the third generation Carlson family member to own and operate the automation machinery engineering and manufacturing business.
Glen worked at Acme for 58 years managing and directing manufacturing operations, sales and further advancing as vice president, president, and chairman, retiring in 2016.
Glen joined Acme in 1958 following in the footsteps of his father Glen Carlson Sr. and his Grandfather Gustav Carlson, who founded Acme in 1910.
Highly recognized and respected internationally as an industry leader in metal finishing automation machinery. He was instrumental in providing coated abrasive belt coil, strip, sheet grinding systems in the steel industry and coated abrasive belt centerless grinding machinery for the tube, bar, and hydraulic cylinder industry.
In 1983 Glen and his brother Don Carlson (former VP and President of Acme) developed a relationship with FANUC Robotics Ltd, formerly GMF Robotics Corp. This partnership introduced the use of flexible robotic technology to the metal finishing industry and has become paramount in providing integrated automation systems and solutions globally.
Glen also established and embraced Acme’s policy to providing complete and unlimited customer service with total customer acceptance. This commitment is well known worldwide in the industry and a valuable Acme trademark today.
Glen held an engineering undergraduate degree and MBA from the University of Michigan and was instrumental in developing several Acme machine patents.
Acme Manufacturing Co. was purchased by Glen’s son, G.A. “Fritz” Carlson III, in 2017 who is the fourth-generation family member owner, president and CEO.
Glen is survived by his wife Mariel Carlson, sons G.A. “Fritz” Carlson III, Steve Carlson, Dr. Rob Carlson, Brad Carlson, brother Don F. Carlson, sister Jane Carlson Bowen, and their families.
Glen was a member of Bloomfield Hills Country Club and the Birmingham Athletic Club in Bloomfield Hills, Michigan.
Glen’s legacy will truly be missed.
Scott Taylor has joined MC Machinery’s Consumables Product Group (CPG) as the Southeast regional sales manager for laser consumables.
Taylor has more than 20 years of experience in the manufacturing industry, including OEM product development and sheet metal fabrication.
Based in Greenville, S.C., Taylor will serve customers in South Carolina, North Carolina, Georgia, Florida, Alabama, Arkansas, Louisiana, Mississippi, and Texas.
“Scott will be a tremendous asset to our customers in the Southeast region, especially with his experience operating lasers and developing OEM products,” said MC Machinery CPG National Sales Manager George Johnson.
Taylor can be reached at scott.taylor[at]mcmachinery.com.
Jack Crawford has filled a position of Application Specialist at GWS Tool Group.
In this role, Jack will be responsible for supporting GWS distributors and key metalworking customers in the application of GWS high-performance cutting tool solutions. Cutting tools from GWS include both standard and purpose-built tooling such as end mills, form tools, step tools, drills, reamers, taps, and PCD tipped tooling along with countless variations of special turning inserts.
For several years he has been applying his knowledge at the spindle, helping to optimize production requirements, and strengthening sales for his customers. He has a vast channel partner cutting tool knowledge base and has proven successes of bringing good solutions to the spindle. Jack started his career in Bozeman, MT as an Engineering Intern learning the technical skills for assembly, operation, and maintenance of Unmanned Aerial Vehicles along with preparing detailed design packages for contract manufacturers utilizing SolidWorks. After honing his skills on the machine tool side, Jack moved into sharpening his skills in CAM software programming while using complex cutting tool solutions such as Gear Skiving, while working for a highly regarded global cutting tool manufacturer.
“Jack’s extensive metalworking and process improvement experience is an ideal fit for our organization,” said Scott Tiehen, Director of Sales – West. “His Mechanical Engineering background coupled with Aerospace experience and a successful track record working with key channel partners and end users will immediately add value to our customers.”
For GWS, Jack will be responsible for business development and application support for our channel partners and end users in Washington, Oregon, Idaho, Montana, and Alaska. 360-506-9058; jcrawford[at]gwstoolgroup.com
Trelleborg Sealing Solutions is pleased to announce that Linda Muroski has been named one of Industry Era’s 10 Most Inspiring Women Leaders of 2021. Muroski is the president of Trelleborg Sealing Solutions Marketing Americas and Global Healthcare & Medical.
Upon joining Trelleborg in 2016, Muroski immediately led the business to achieve its 2020 strategic plan one year early. In doing so, she championed diversity, fostered collaboration, and empowered her team, resulting in greater accountability, increased employee satisfaction, and improved business results.
“Linda’s attitude and approach to her work at Trelleborg is reflective of our company strategy for growth,” says Peter Hahn, business area president of Trelleborg Sealing Solutions. “She understands that collaboration across business units is key and that it’s necessary to trust each other to do our best work. I’ve seen Linda ‘walk the talk’ and lead real change, which is why our team has been so successful under her leadership.”
More recently, Muroski launched the Together 2025 initiative which consists of four key pillars expected to deliver results ― talent, innovation, market, and excellence. Muroski created this initiative knowing it would require extensive teamwork and collaboration but trusts that her team is up to the challenge.
“Linda encourages me to share and develop my ideas into capabilities Trelleborg will rely on for years to come,” says Heather Castleman, senior director of strategy & marketing. “She is a strong supporter of professional development and challenges me to expand my skillset and leadership capabilities. She is a purposeful mentor, and I will be forever grateful for all of the opportunities she’s presented to me during our time working together.”
With a keen eye for growth opportunities, the global Healthcare & Medical business unit was formed. As the leader of the new business unit, Muroski assembled an astute leadership team which is working to integrate the acquired businesses. Thanks to her entrepreneurial spirit and expertise, Trelleborg Healthcare & Medical has succeeded in delivering innovative solutions and consistent, high-quality products that help improve patients’ lives worldwide.