Biodesign

Dr. Kleinke has over 25 years of industry experience in the design and development of electro-mechanical systems. As a tenure-track faculty member of the UDM mechanical engineering department, he has adopted a program of instruction which UDM has branded "Faces on Design". The guiding principle is that student project work is more meaningful and fulfilling when students have the opportunity to see and experience the faces of real live clients. In the series of design courses he teaches, students design mechanical devices for use by disabled clients. The students are required to interview the client and design a device that will address one of the client's unmet needs. The series concludes with students presenting prototypes of designs. The reactions of the client, as seen in their faces, is the ultimate grade. In addition to academic work, Dr Kleinke is a registered professional engineer and conducts seminars on innovation which are tailored to the needs of automotive engineers. Dr Kleinke's recent publication, "Capstones Lessons to Prepare Students for the Changing World of Corporate Innovation", was awarded fist place as "best paper" at a 2011 regional conference of the American Society for Engineering Education. Dr. Molly McClelland, University of Detroit MercyDr. McClelland is an Associate Professor of Nursing at the University of Detroit Mercy. She has over 25 years of health care experience working in a variety of hospital and health care settings. She has a passion for helping people who have physical health care needs. Dr. McClelland has been collaborating with the College of Engineering for 8 years. The multidisciplinary collaboration blends nursing students with engineering students to build innovative assistive technologies designed to improve the lives of people who live with physical disabilities.

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“…al. 16 LTU requires 3 and 2 credits, while UDM requires 2 and 3 credits (respectively). Introduce all students to the program plan.…”

Section: Timeline / Milestonesmentioning

confidence: 99%

Multidisciplinary Patient-Centered Capstone Senior Design Projects

Nasir¹,

Kleinke²,

McClelland³

2016 ASEE Annual Conference &Amp; Exposition Proceedings

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“…The premarket approval (PMA) process was introduced by the 1976 law specifically for devices. PMA submissions require the following: "valid scientific evidence" provided by extensive testing that "provide(s) reasonable assurance that the device is safe and effective for its intended use" (Yock, Zenios et al 2015). This rigorous process is applied rightfully to medical devices that "support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury" (Maisel 2005).…”

Section: Medical Device Regulationmentioning

confidence: 99%

“…The intention of the 510(k) provision was to provide a less burdensome and less expensive path for newer versions of existing devices to enter the market by requiring only a demonstration that the device was "substantially equivalent" in materials, purpose, and mechanism of action to another device that was already marketed. (Yock, Zenios et al 2015). Table 1.…”

Section: Medical Device Regulationmentioning

confidence: 99%

“…Table 1. FDA device classification (Yock, Zenios et al 2015). Approximately 75% of Class I and less than 10% of Class II devices do not require FDA clearance to be marketed (Yock, Zenios et al 2015).…”

Section: Medical Device Regulationmentioning

confidence: 99%

“…FDA device classification (Yock, Zenios et al 2015 The progression of medical devices contributes to countless saved lives by enabling the alleviation of pain, conquering of disability, and sustainment of life.…”

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confidence: 99%

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A novel approach to assess minimally invasive surgical device failure utilizing adverse event outcome severity and design complexity.

Riggs¹

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Development and Characterization of a Novel Composite Hydrogel Biomaterial for Improved Mucoperiosteal Wound Repair

Wang,

Dunnwald,

Kacmarynski

et al. 2024

J Biomed Mater Res

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Mucoperiosteal wound healing, as it occurs after pediatric cleft palate surgery, can be challenging due to the limitations of current treatments such as tissue flaps secured with sutures and fibrin glue. In this study, we characterized the in vitro performance of a novel composite hydrogel biomaterial designed to be employed as an in situ wound filler and enhance mucoperiosteal wound healing. We evaluated a range of photopolymerizable formulations containing methacrylated gelatin (GelMA), glycol chitosan, and bioglass microparticles. Our aim was to identify one or more formulations with an appropriate balance of properties against a set of functional requirements that we established for this application. To test the formulations against these criteria, we measured photopolymerization kinetics, mechanical properties, degradation rate, in vitro biocompatibility, and ex vivo tissue adhesion. All formulations polymerized in less than 90 s using violet light. In addition, we found that GelMA‐based hydrogels were more adhesive to mucoperiosteal tissue than clinical standard fibrin glue. Inclusion of small amounts of bioglass in the formulation increased mechanical compatibility with mucoperiosteal tissue, enhanced cytoconductivity, and promoted cell proliferation. Taken together, our results support the suitability of these photopolymerized composite hydrogels as in situ mucoperiosteal wound fillers. Overall, this study lays the groundwork for investigating the in vivo, pre‐clinical effectiveness of these composite hydrogels in improving mucoperiosteal wound healing outcomes.

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Biodesign

Cited by 129 publications

References 0 publications

Multidisciplinary Patient-Centered Capstone Senior Design Projects

Multidisciplinary Patient-Centered Capstone Senior Design Projects

A novel approach to assess minimally invasive surgical device failure utilizing adverse event outcome severity and design complexity.

Development and Characterization of a Novel Composite Hydrogel Biomaterial for Improved Mucoperiosteal Wound Repair

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