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ABOUT US

Patient Success Starts Here.

Welcome to MedLaunch, where innovation meets expertise. At the heart of our organization are our founders, Nathan Glass and Nichole Leahy-Glass, who bring over 20 years of combined experience in the medical device market.

 

Their journey, rich in knowledge and driven by a passion for advancing healthcare technology, has been the cornerstone of MedLaunch. Together, they have cultivated a team equally committed to excellence, integrity, and innovation.

 

Our story isn't just about the milestones we've achieved; it's about the people behind our success and the shared vision that propels us forward. Join us in exploring how our expert team is making a remarkable difference in the field of medical device development and regulatory pathways.

Vaccine
Expert Guidance
in Action

Lighting the Path to

Market Success

Nurse And Patient
Patient-Centric 
Innovation

Focus on Exceptional

Patient Outcomes

Desk with Stethoscope
Safety and Quality
Assurance

Safety and Quality

is Our #1 Priority

OUR TEAM

Innovative Solutions for Better Healthcare

We specialize in medical device product development, regulatory compliance, and quality system implementation alongside contract manufacturing services. With over 20 years of experience in the industry, we are dedicated to helping startup and growth Medtech organizations navigate the complex regulatory environment, build quality systems, and ensure their products meet all regulatory requirements. Our team of experts is committed to delivering the highest quality services to our clients, and we work tirelessly to ensure that our clients receive top-notch support throughout the entire product development cycle.

Nathan Glass

Nathan Glass

President & Principal Consultant 

Nathan Glass stands at the forefront of MedLaunch as its Founder, CEO, and Principal Consultant, bringing a wealth of experience that spans over 15 years in the medical device industry. His journey began as a Product Development Engineer, where he honed his skills in R&D, risk management, validations, and preparing 510(k) submissions. Nathan's early career was marked by his significant contributions to building robust Design History Files, laying a solid foundation for his deep understanding of the medical device development process.

Transitioning into manufacturing and engineering management, Nathan excelled in implementing quality systems and procedures. He was instrumental in developing new prototyping and manufacturing processes, showcasing his versatility and commitment to enhancing operational efficiencies. His expertise in process risk management and validations further underscored his comprehensive skill set. In 2016, Nathan expanded his impact by stepping into medical device consulting. This move was driven by his desire to apply his medical device knowledge more broadly and assist innovators in bringing their devices to market while maintaining compliance.

Nathan's consulting journey has been marked by global collaborations across various specialties, including surgical, orthopaedic, cardiovascular, dental, and more. His diverse experience reflects a deep understanding of the multifaceted nature of the medical device sector. Holding a BS in Biomedical Engineering from Purdue University, Indianapolis, and being an ASQ Certified Quality Auditor, Nathan embodies a blend of technical expertise and regulatory acumen.

 

His leadership at MedLaunch is not just about guiding the company but about shaping the future of medical device innovation and compliance.

Nichole Leahy-Glass

Nichole Leahy-Glass

VP of Operations & Principal Consultant

With 14 years of experience in the medical device industry, Nichole Leahy-Glass is an accomplished medical device expert and a driving force behind MedLaunch. As Co-Founder and Chief Operations Officer, she brings a wealth of knowledge and a track record of success in regulatory compliance and operational excellence.

Nichole's journey in the medical device sector began at Purdue University earning her B.S. in Biomedical Engineering. Her expertise is further backed by a range of professional certifications, including being an ASQ Certified Quality Auditor and holding a Lean Manufacturing Certificate from the University of Michigan, along with ASQ Process Validation Training. These qualifications underscore her deep understanding of quality assurance and efficient manufacturing practices.

Before co-founding MedLaunch, Nichole's impressive career included notable senior-level and executive roles at G&H Orthodontics where she started as the Director of Quality Assurance and Regulatory Affairs and was promoted to Vice President of Operations and RA/QA.  As Vice President of Operations, she oversaw two manufacturing plants and over 200 employees during her tenure. Her achievements in streamlining processes, enhancing product quality, and navigating complex regulatory landscapes have set high industry standards.

At MedLaunch, Nichole leverages her extensive experience to guide medical device startups and established firms through the intricacies of product development and market compliance. Her commitment to operational excellence and her strategic approach to regulatory challenges make her an invaluable asset to the MedLaunch team and its clients.

Babacar

Babacar Diouf

Principal RA/QA Consultant

Babacar Diouf brings over two decades of expertise in Engineering, Quality Engineering, Regulatory Affairs, and Quality Management Systems to his role, including a decade as an executive focusing on regulatory affairs and quality systems in the medical device industry. He has successfully obtained market clearances across multiple regions including the USA, Canada, EU, and more, and excels in quality management within manufacturing environments. His comprehensive experience covers the entire medical device lifecycle, emphasizing regulatory planning, risk management, and various validations including cleanroom validation.

Prior to his current role, Babacar worked in geochemical exploration for gold and base metals in Africa, and in various capacities at companies like Autoliv ASP, CRI Medical Devices, and 3DT Holding, LLC. Originally from Senegal and fluent in four languages, Babacar holds a Geological Engineering degree and a Master's in Executive Leadership and Organizational Change. He is a senior member of ASQ, a member of RAPS, and holds multiple certifications including ASQ Certified Quality Auditor and ISO13485:2016 Auditor.

Joseph Mooar

Joseph Mooar

Sr. Product Development Engineer

Joseph Mooar is our dynamic Sr. Product Development Engineer at MedLaunch, bringing a focused expertise in process validations, improvements, and quality monitoring within the medical device sector. Joseph's professional journey began at G&H Orthodontics in Franklin, IN, where he dedicated just under a year to enhancing quality engineering processes. His role involved a hands-on approach to process validations and improvements, laying a solid foundation for his proficiency in quality assurance.

Joseph's career further evolved at Cook Medical, where he initially served as a Manufacturing Quality Engineer in Ellettsville, IN, concentrating on process nonconformance evaluations. His adaptability and technical acumen led to a transition into a Process Development role in R&D at Cook Medical's main branch in Bloomington. In this capacity, Joseph played a pivotal role in developing processes for a stent-delivery system used in arterial-aortic aneurysm treatments.

 

Joining MedLaunch.tech in 2023, Joseph brings his valuable experience and a Bachelor of Science in Biomedical Engineering from Purdue University-Indianapolis to the team. His tenure in the industry is marked by significant contributions to medical device innovation and quality engineering.

Austin Crouse

Austin Crouse

Sr. Engineering Consultant

Austin Crouse is an accomplished Quality Engineering professional with a blend of experience in postmarket surveillance, quality assurance, and biomedical engineering. Bringing over six years of dedicated experience in the medical device industry, Austin has established himself as a leader, steering teams of quality engineers towards achieving exceptional standards in procedural adherence and continuous improvement. His proficiency extends to conducting comprehensive risk assessments and managing Quality Management Systems (QMS), ensuring top-tier quality and compliance in all projects.

In addition to his role as a Senior Engineering Consultant, Austin is the driving force behind Crouse Engineering, LLC, where he operates as the owner and Biomedical Engineering Consultant. In this capacity, Austin has excelled in designing and developing novel medical products, collaborating with clients on design changes, and managing QMS in line with ISO 13485 and FDA CFR 820 standards. His leadership is further exemplified by his successful endeavors in leading continuous improvement projects and reconstructing data servers, enhancing overall efficiency and data integrity.

Austin holds a Bachelor of Science in Biomedical Engineering and a Master of Science in Engineering Management, both from Trine University. His credentials are augmented by a certification as a Professional in Mechanical Design from Dassault Systems (Solidworks) and a Six Sigma Yellow Belt. Austin's skills are diverse, ranging from proficiency in MiniTab, and SAP Business Objects, to expertise in PLM, lab techniques, product development, and quality management. His comprehensive skill set and innovative approach make him a valuable asset to any project in the medical device sector.

Kathy Shreve

Kathy Shreve

Sr. Engineering Consultant

Kathy Shreve brings an invaluable combination of experience from the automotive and medical device sectors. With over six years in product, production, and analytical engineering in the automotive industry, Kathy transitioned her expertise to the medical device field in 2020. Her initial experience in this sector was marked by her impactful work with Kasota, LLC, where she was instrumental in implementing Quality Management Systems (QMS) for medical device startups. Her role encompassed vital responsibilities such as preparing for management reviews and enhancing Standard Operating Procedures (SOPs), demonstrating her adaptability and meticulous approach to quality systems.

Kathy continues to leverage her extensive experience as the owner of Pensato LLC, where she has been offering specialized consulting services since 2021. She excels in conducting remote third-party internal audits in compliance with ISO 13485:2016, affirming her commitment to maintaining the highest standards of quality assurance. Kathy's expertise further extends to developing and refining SOPs, Work Instructions (WIs), and forms, as well as building robust QMS frameworks for startups in the medical device industry.

Her background in Mechanical Engineering, combined with her 3.5 years of focused experience in medical device consulting, makes her an invaluable resource at MedLaunch, offering a unique blend of technical proficiency and regulatory insights.

Mariema Thioune

Mariema M Thioune Sambe

Sr. Regulatory Consultant

Mariema M Thioune Sambe is a seasoned Quality Consultant at MedLaunch, bringing over six years of dedicated experience in quality assurance and customer service. Her journey in the medical device industry is distinguished by her role in processing returns and her significant contributions to premarket strategy development. Mariema's expertise extends to drafting regulatory submissions and ensuring post-market compliance, vital elements in the product life cycle of medical devices. Her work has been pivotal in guiding medical device companies through the intricate process of 510(k) submissions, facilitating FDA clearance for new products in the United States market.

Mariema's academic background is as diverse as it is impressive. She holds a Regulatory Affairs Certification from Ivy Tech Bloomington, obtained in 2021, and a Doctor of Pharmacy degree from Senegal, West Africa, earned in 2011. Her proficiency is further enhanced by a White Belt Certificate in Lean Six Sigma, demonstrating her commitment to continuous improvement and operational excellence. Known for her detail-oriented approach and strong adherence to Good Documentation Practices, Mariema is also adept in navigating FDA regulations , a skill that greatly benefits her work in regulatory affairs. Her combination of robust educational qualifications and extensive industry experience makes her an invaluable asset to the MedLaunch team and its clients.

Wade Warner

Wade Warner

Marketing Manager

Wade Warner, the Marketing Manager at MedLaunch, brings over a decade of experience in marketing within a wide range of industries to the exciting world of medical technology. Having served in numerous roles across the country, Wade has honed a deep understanding of effective marketing strategies and consumer engagement. His passion for marketing is complemented by a consultant’s mindset, ensuring that MedLaunch's offerings are communicated clearly and effectively to their clients.

Wade holds a Bachelor of Science in Public Affairs from Indiana University, furthering his expertise, Wade completed his MBA from the University of Southern Indiana equipping him with advanced skills in business administration and strategic marketing. At MedLaunch, Wade leverages this blend of practical experience and academic knowledge to drive innovative marketing initiatives, playing a key role in shaping the company's outreach and customer relationships.

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