Ediuska Laurens

Career

Ediuska Laurens is a biomedical engineer, consultant, and expert witness specializing in medical device product development, regulatory compliance, and quality assurance. Her accomplishments include the development and regulatory clearance of bioresorbables, bone cements, and distraction technologies in the United States and European Union. She is an inventor and patent holder of two craniomaxillofacial technologies.

Laurens has experience with pediatric implants and hydrogel biomaterials for tissue engineering and orthopedics, including applications in spine and cartilage repair. She is a developer and investor in emerging medical technologies that serve vulnerable populations, such as women's health and pediatrics. Laurens is also a published author and frequent speaker.

Education

Laurens holds a Doctor of Engineering degree in Biomedical Engineering with a focus on Biomaterials from the Cleveland Clinic Foundation - Cleveland State University, obtained in May 2009. She earned a Master of Science degree in Mechanical Engineering with a concentration in Biomaterials from the State University of New York (SUNY) at Buffalo in May 2005. Additionally, she received a Bachelor of Science degree in Aerospace Engineering from SUNY at Buffalo in May 2003.

Professional Experience

Founder & CEO, Genius Shield LLC (November 2018 - Present)

As the Founder and CEO of Genius Shield LLC, Laurens has successfully helped clients bring their medical devices to market through regulatory and quality compliance services, including FDA submissions, regulatory planning and strategy, product registrations, and quality management system implementation. She manages a team of regulatory, quality, and product development experts from top Fortune 500 medical device companies.

Laurens serves as a subject matter expert in craniomaxillofacial and neural implants, biomaterials, hydrogel biomaterials, tissue engineering and regeneration, orthopedics, spine, FDA and EU regulations, and medical device quality assurance. She also provides expert witness services to both plaintiff and defense counsel in biomedical engineering, FDA regulations, product manufacturing and safety, and medical device regulations and quality management systems.

Senior R&D Project Manager, Stryker Craniomaxillofacial (January 2011 - October 2018)

At Stryker, a leading medical technology company, Laurens advanced from Biomaterials Project Engineer to Project Manager to Senior Project Manager. She led a global cross-functional team focused on customer-centered design principles, regulatory, quality, operations, and marketing to drive high-quality bioresorbables, distraction, and bone cements medical solutions to market.

Laurens successfully managed, developed, acquired regulatory clearance, and globally commercialized several products, including the Stryker DirectInject Bone Cement, the Stryker Delta Bioresorbable System, the first Stryker Pediatric Mandibular Distractor, and the second generation of the Stryker Pediatric Mandibular Distractor with an anti-reverse mechanism and sterile version. She also innovated and acquired two patents in bioresorbable and distraction technologies, receiving the Stryker Patent Innovation Award in 2017.

Research Engineer - Post Doctoral Fellow, Cleveland Clinic Foundation Lerner Research Institute (September 2005 - December 2010)

At the Cleveland Clinic Foundation's Lerner Research Institute, Laurens assessed the mechanical properties of Tyramine Crosslinked Hydrogel Biomaterials as a potential implant to replace the nucleus pulposus in the spine for treating degenerative diseases. She contributed to the development of a biocompatible tyramine-substituted hyaluronan hydrogel technology licensed by Lifecore Biomedical for various clinical applications, including knee cartilage and spine repair, dura sealants, dermal fillers, ophthalmic treatments, and tissue engineering.

Laurens also contributed to the MRI field by using T1 and T2 mapping and creating a hyaluronan and collagen hydrogel phantom system that allows accurate monitoring of changes in concentration induced by the loss of glycosaminoglycans and collagen in cartilage, which are critical for osteoarthritis treatment.

Research Assistant, State University of New York (SUNY) at Buffalo (May 2002 - August 2005)

During her time as a Research Assistant at SUNY at Buffalo, Laurens worked at the Center of Biosurfaces, where she developed a method for photo-crosslinking Human Wharton's gel in the presence of Eosin Y dye as a novel potential tissue engineering system. She also assessed the viscoelastic properties of polyvinyl alcohol (PVA) hydrogels and their suitability as spinal intervertebral disc replacements.

At the Toshiba Stroke Research Center, Laurens designed a laser-induced fluorescence system that enabled monitoring blood flow and measuring the flow field effect of placing a stent in the aneurysmal portion of a curved vessel.

Additionally, she developed a method for early detection of calcified carotid arteries using panoramic dental x-rays, which could help provide timely treatment to patients.

Inventions

Laurens holds two issued patents:

• US2014/0148812A1 - "Pediatric Internal Mandibular Distractor" (Inventors: Ediuska Laurens, Stephen Harris, Nathan Gorentz)
• US2015/0297273A1 - "Delta Panels with Countersink" (Inventors: Stephen Harris, Ediuska Laurens, Julia Zelenkova)

She also has an invention disclosure, R-5941 - "Method of Wet Bonding of Tissue to Mineral, and Resultant Prostheses," filed on July 8th, 2004, with Ediuska Laurens and Robert Baier as inventors.

Publications

Laurens has several publications in peer-reviewed journals, including:

• "A Synthetic Cartilage Extracellular Matrix Model: Hyaluronan and Collagen Hydrogel Relaxivity, Impact of Macromolecular Concentration on dGEMRIC" in Skeletal Radiology
• "Analysis and Biomechanics of Tyramine Cross-Linked Hyaluronan Hydrogels" in the Journal of Biomechanics
• "Mechanical Testing of Crosslinked hydrogels for Nucleus Pulposus Replacement" in the Journal of Biomechanics
• "Customized Spinal Disc Prosthesis with Glass-Ceramic Annulus and Human Wharton's Gel Nucleus Pulposus" in the Proceedings of the 24th Canadian Biomaterials Society Conference

Conference Presentations

Laurens has presented her work at various conferences, including:

• MedTech and the Future of Medicine Panel at the Maryland Tech Council - Chesapeake Regional Chapter
• Swissnex Fostering Equity in Women's Health
• Fem Tech Focus Summit
• The International Society of Biomechanics Congress (ISB)
• The North American Congress of Biomechanics (NACOB)
• The European Society of Biomechanics (ESB) Congress
• The Annual Meeting of the Orthopedic Research Society (ORS)
• The Canadian Biomaterials Society Conference
• The Hulbert Conference "Bioengineering with Glass-Ceramics"

Affiliations

Laurens is affiliated with the following organizations:

• Regulatory Affairs Professional Society (RAPS)
• International Society of Biomechanics (ISB), where she served as the Economically Developing Countries Champion
• Corporate Member of the Women's Health Innovation Coalition
• Advisor at Springboard Enterprise
• Venture Fellow Partner at FundRX (April 2018 - March 2021)

Awards and Accomplishments

Laurens has received several awards and honors, including:

• Created the second Clinical Gait Analysis Laboratory in Venezuela
• First Latina elected as the Student Representative to the International Society of Biomechanics
• 2020 STEM Women in a S.T.E.M. World Award from Women's History Month at Cleveland State University
• Invited guest at the Women and Girls in Science Assembly at the United Nations
• Guest Lecturer at Columbia University Department of Biomedical Engineering
• Stryker Patent Innovation Award in 2017
• Panelist at ISPE - Women in Pharma Influencing Change and Promoting Growth, sponsored by Johnson & Johnson
• International Leader Guest at the Med In Ireland Conference, sponsored by Enterprise Ireland
• Invited guest at the Forum on Women's Leadership and Panel Discussion, sponsored by the Irish Consulate in New York
• Scientific Reviewer of "Biomaterials and Medical Devices" at the International Society of Biomechanics (ISB) Congress in Brussels, Belgium
• Invited guest to the "Zero Power Smart Fashion Wearable Sensors and Green Energy" Symposium by Zero Power Smart Systems Initiative EPFL and ETH Zurich and Swissnex Boston in New York
• Travel Grant Award from The International Society of Biomechanics
• Doctoral Dissertation Research Award from Cleveland State University
• Graduate Student Travel Award from the Cleveland Clinic
• National Honor Society Award, Phi Eta Sigma
• Dean's List at the University at Buffalo