K. Marya Chaisson, M.D. Appointed to Actuated Medical’s Medical Advisory Board
“Dr. Chaisson brings a patient-focused approach to Actuated Medical ensuring the patient is the focus of all our medical device design. Her expertise will help move Actuated move up and onward,” said Maureen Mulvihill, President and CEO of Actuated Medical.
“I have been thoroughly impressed with the growth and innovation of Actuated Medical over the years. I am excited to be a member of their Medical Advisory Board and provide my perspective on projects that will help patients along their health journey,” said Marya Chaisson, M.D., Medical Advisory Board Member at Actuated Medical.
Dr. Chaisson’s values strongly align with Actuated’s mission to improve patient outcomes. She is known for being empathetic to her patient’s diagnoses on a personal level, thereby furthering her level of care. Dr. Chaisson brings Actuated’s Medical Advisory Board to a strong seven members total. The board advises on civilian and military medical needs, clinical best practices, clinical and device usability, health economics, and hospital purchasing.
The TubeClear System – Clinical Study of Mechanical Enteral Tube Declogging in a Skilled Nursing Facility
Robert Buckley RN, CCM
Steve Heisa, RN
August 2021
NeuroRestorative, Riverton, Utah
Introduction
The use of enteral feeding tubes has greatly enhanced delivery of nutrition, fluids and medications in the clinical setting. Despite the benefits, some of these enteral feeding devices are prone to clogging. These clogs are often related to delivery of crushed medications as well as enteral feeding formulas. Regardless of the cause, clinicians have very limited options for declogging these enteral tubes. The main limitation is getting any form of solvent to the clog as many tubes are thin in diameter and long in length. Many forms of declogging techniques have been attempted with solvents such as warm water, cola, meat tenderizer, enzymes and high pressure flushing.
Actuated Medical’s President and CEO Awarded International Chief Science Officer (CSO) Mentor of the Year
Maureen L. Mulvihill, Ph.D., was awarded the 2022 International Chief Science Officer (CSO) Mentor of the Year at the June CSO Saturday Meeting. The meeting involved Science, Technology, Engineering and Math (STEM) students from Arizona, Georgia, Oregon, Kenya, the Philippines, and Mexico. CSO Mentors are community leaders and professionals who serve as role models for students in grades 6-12 that want to pursue STEM careers. Over the past two years, Maureen has been involved with the ENGINE of Central PA CSO program. Last year, Maureen participated as a STEM panelist during the CSO’s Leadership Training Institute. This year, Maureen opened Actuated’s doors to several high school students for a CSO Shadow Day opportunity to learn about engineering careers and presented to CSOs across the world during a medical technology themed CSO Saturday event.
“The CSO program gives students the opportunity to learn about STEM related fields and to build leadership skills by developing STEM programs in their communities. The CSO student have such positive energy and are so eager to learn. I am very honored to receive the 2022 International Chief Science Officer (CSO) Mentor of the Year award,” said Maureen L. Mulvihill, President and CEO, Actuated Medical.
“CSO International appreciates professionals like Maureen who share their journey and encourage students to persevere through challenges they face both now and in their future. The relationships developed through mentorship are priceless,” said Kelly Green, Director of Student Success, CSO International.
“Mentoring partnerships like we have with Maureen and Actuated Medical are incredibly important for our students to help them authentically engage in STEM in their communities. Maureen’s mentorship is an example of our vision for future mentor partnerships as the program grows across the ENGINE of Central PA region over the next two years,” said Tiffany Lewis, Lead Cabinet Coordinator for the ENGINE of Central PA CSO Program and STEM Education Outreach Specialist at CSATS.
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About Actuated Medical, Inc.
Actuated Medical develops medical devices that integrate electronically controlled motion technologies that improve patient outcomes and reduce healthcare costs. They give back to the community by providing frequent STEM opportunities to middle school, high school and college students. They also provide summer engineering internships to high school and college students so that they can learn about medical device development, FDA regulations and clinical end-user discovery. Actuated Medical is a certified women-owned business located in Bellefonte, PA and is ISO 13485 certified.
For more information, please visit http://www.actuatedmedical.com.
About Chief Science Officers International
The Chief Science Officer (CSO) Program aims to encourage student voice through leadership opportunities with a focus on STEM and creates a network of diverse STEM leaders who function as a liaison for STEM opportunities and innovation in their communities. The CSO International program was established 7 years old and has over 1000 students CSO participants.
For more information on the CSO Program, please visit https://chiefscienceofficers.org/
About ENGINE of Central PA
ENGINE of Central PA, a STEM Learning Ecosystem, the project of The Foundation for Enhancing Communities, fiscal agent, ENGINE of Central PA is one of the few university-led ecosystems to bring meaningful STEM research and innovations to K-12 education. ENGINE of Central PA, a nationally recognized STEM Learning Ecosystem, piloted the CSO program this past year with student leaders from Bald Eagle Area School District, Moshannon Valley School District, and Mifflin County School District. The CSO program is co-lead by Penn State Center for Science and the Schools (CSATS), Central Intermediate Unit 10, and Tuscarora Intermediate Unit 11 with support from the State College AAUW chapter and Siemens. For more information on ENGINE of Central PA, please visit https://www.enginecentralpa.org/
Actuated Medical Offering Specialized Product Development for MedTech Innovators
Actuated Medical Offering Specialized Product Development for MedTech Innovators
Actuated Medical specializes in taking medical devices from concept to market-ready products – from start to finish. They have deep expertise in tissue dynamics and penetration, acoustic engineering, electronics and software development, and 3D printing. They focus exclusively on the development of medical devices and are currently helping other Innovators solve design and regulatory challenges. Actuated’s facility doubled in 2021 and has increased its capacity to conduct contract product development and manufacturing including customer equipment placement.
“Our exceptionally skilled team includes electrical, mechanical, and biomedical engineers with expertise in medical device commercialization. We are currently helping several innovators solve engineering problems. With our expansion, we have the capacity to help others,” said Maureen L. Mulvihill, President and CEO of Actuated Medical.
A recent client is an ER physician. He came to Actuated with a patent for a device and asked Actuated to take his product from concept to FDA submission. Actuated’s engineering team investigated the design and built some feasibility prototypes using Actuated’s rapid prototyping facility. Verification and Validation (V&V) protocols were written, testing was performed, and test reports were completed. Included in V&V was usability testing with 30 participants. The device passed V&V, and Actuated Medical’s team wrote and submitted the 510(k) application. The device is pending FDA clearance.
“I took my patent to Actuated Medical, and they completed all the V&V testing, wrote and submitted the 510(k). Because of Actuated my patent is now a medical device,” said Brian Shippert, DO, Emergency Physician, Shippert Tech, LLC.
2022 SAGES Next Big Thing Podium Presentation
Novel accessory designed to facilitate complex endoscopic mucosal resection
Eric M Pauli MD, Joshua S Winder MD, Vamsi V Alli MD
Penn State College of Medicine, Penn State Hershey Medical Center, Hershey, PA.
Objective
The GripTract-GI endoscopic tissue manipulator (Figure 1) is a novel cap-based endoscopic accessory designed to facilitate complex endoscopic mucosal resection. The goal of this study is to evaluate the efficacy of the manipulator during en bloc removal of simulated colorectal mucosal lesions in benchtop and preclinical studies.
Technology Application
The primary goals of the platform include; facilitating safe endoscopic submucosal dissection (ESD) methods, broadening application of ESD for clinicians with less extensive training, and improving ESD outcomes. This approach may enable organ sparing surgery in colorectal lesions traditionally deemed endoscopically unresectable. The manipulation of external “fingers” by the clinician using a simple proximal handpiece attached to the endoscope control body enables dynamic traction and countertraction of tissues facilitating electrosurgical knife use during ESD. The technology is compatible with standard colonoscopes and can be attached and removed without altering the colonoscope.
Preliminary Results
Functional prototypes utilizing this technology were developed and studied as an adjunct in removal of mucosal tissue through ESD. Wet laboratory ESD studies were first performed on porcine stomach tissue by physicians to gain familiarity with the GripTract-GI system and controls. While working with the device, physicians also discovered several unanticipated maneuvers to perform dynamic tissue retraction and to increase the degrees-of-freedom of the electrosurgery tools. These techniques were employed during preclinical porcine studies (n=10 of 14 at time of abstract), where each animal underwent one standard cap-assisted ESD and one GripTract-assisted ESD for comparison. En bloc mucosal resections of up to 6.5 cm2 were performed. Preliminary data shows that with comparable resection areas between standard and GripTract (1.98 ± 0.61 cm2 vs. 2.46 ± 0.80 cm2, p=0.65), resection speeds were also similar (5.33 ± 1.89 mm2/min. standard vs. 5.70 ± 1.55 mm2/min. GripTract, p=0.88). However, the average relative resection speed (GripTract to standard) increased over repeated procedures for each physician, and the perforation rate for GripTract was 50% of that when using standard technique.
Conclusions
In this first preclinical evaluation of the GripTract-GI endoscopic tissue manipulator there was specific utility of this technology to facilitate large mucosal resections. The increase in resection speed with GripTract relative to standard technique over several procedures provides preliminary evidence for a faster learning curve and possible expansion of the pool of clinicians capable of offering ESD – though more studies are warranted before final conclusions are made. Although initially intended for colorectal lesions, this platform has future potential for upper gastrointestinal endoscopy interventions, such as in esophageal or gastric ESD.