Michael Nilo, MS - President & Principal Consultant

Michael Nilo has worked in the medical device industry since 2009, including 6 years as a lead reviewer with the US FDA. He has direct experience with FDA device review processes and intricacies. He has hands-on familiarity with most functions and departments of a successful medical device company, and has provided consulting advice for verification and validation testing, quality systems, and regulatory submissions for different classes of medical devices. He authored and submitted applications to FDA for Class II and III medical devices, and has extensive experience with clinical trial development for medical devices, quality system regulations, and all manner of FDA interactions. He’s an effective public speaker, teacher, copy editor, and troubleshooter with a strong foundation in physics, biochemistry, mechanobiology, mathematics, and written language.

Prior to starting Nilo Medical Consulting Group, Michael worked as a Senior Regulatory Affairs Specialist at Biotronik, Inc., where he worked with international teams to develop regulatory and testing plans to meet FDA requirements. He authored and submitted pre-IDE, 510(k), HDE, IDE, and original PMA submissions to FDA for many cardiovascular device systems, including combination products such as drug-eluting stents and bioabsorbable scaffolds.

Michael also worked at the FDA’s Office of Device Evaluation as a lead reviewer in both the Interventional Cardiovascular Devices Branch and the Dental Devices Branch. He examined pre-market submissions for cardiac medical devices, specifically devices that are inserted into the coronary arteries and the devices used in the interventional procedure (e.g. drug eluting stents, atherectomy systems, PTCA balloons, and guide catheters). He also reviewed dental devices such as implants, abutments, bone-grafting materials, bone plates, and trans-mandibular joint implants. Additionally, he was part of many special interest work groups and policy development teams.

For more information, please see his LinkedIn profile.

Megan Lamberti, MTM, CCRA - Vice President, Clinical & Regulatory Affairs

Megan Lamberti has over 10 years of experience in clinical and regulatory affairs for the development and introduction of novel medical devices, in vitro diagnostics and pharmaceutical products. Megan holds a Master of Translational Medicine degree from the Bioengineering departments of University of California, San Francisco (UCSF) and UC Berkeley and a BS in Biomedical Engineering from Johns Hopkins University.  She began her career working on low-cost medical devices for resource scarce healthcare environments.  She then worked as an engineer for several start-up medical device companies and transitioned to managing clinical and regulatory affairs for a start-up company developing diagnostic and monitoring equipment for the intensive care unit.  Since 2018, Ms. Lamberti has worked as a consultant specializing in clinical trial design and execution and regulatory affairs, including medical writing services.  Megan has worked as a clinical research associate (CRA), monitor and project director on the CRO side of research, in industry, managing clinical affairs on behalf of her clients, and in academia as a clinical research coordinator, which has yielded her cross-functional skill sets in the conduct of clinical research.   

Ms. Lamberti is a certified Clinical Research Associate (CRA) and has expertise with a wide variety of medical devices and in vitro diagnostic products across medical specialties.  She has held roles in medical and technical writing, project management, manufacturing oversight, regulatory submission compilation, development of electronic data capture systems, clinical trial design/initiation/execution/closure, data management, regulatory strategy, non-clinical lab work, and clinical fieldwork.  Megan has expertise in institutional review board (IRB), 510(k), PMA, orphan drug designation (ODD), investigational new drug (IND), CMS coverage request, investigational device exemption (IDE), breakthrough device, and technical file regulatory submissions and has worked on numerous non-significant risk (NSR), IDE and IND trials.

For more information, please see her LinkedIn profile.

Katelyn Lesk - Strategic Business & Regulatory Affairs Manager

Katelyn Lesk has a diverse background in bioengineering and health coaching, both motivated by a passion to improve the quality of life of others.

She started her career working for a medical device start-up company developing a total spine arthroplasty device with experience in this field including testing, protocol development, quality assurance, surgical instrument design, and surgeon training.

In the private sector, Katelyn gained specialized skills with auditing and written documentation such as FDA reports, risk analyses, company procedures, quality assurance documents, marketing materials, and surgeon training manuals, that have been directly applicable to her work in the regulatory industry. She also understands first-hand the challenges that many small companies face, particularly the high importance of quick turnaround times and efficient use of available capital, and strives to bring these values to Nilo Medical.

Katelyn’s experience working with people, businesses, and nonprofit organizations is extensive. In 2012 she started an online health coaching business that she continues to run, caring immensely about her clients and coaches. She has also worked in the development and promotion of local businesses and tech companies in Pittsburgh.

Katelyn volunteers in much of her spare time and is deeply involved in supporting several nonprofit organizations, most prominently 412 Food Rescue as well as its international platform, Food Rescue Hero. With a passion for the outdoors, especially the mountains, Katelyn shares her time between Pittsburgh, Pennsylvania and Avon, Colorado.

For more information, please see her LinkedIn profile.

Sejeal Katiyar, BS - Regulatory Specialist

Sejeal Katiyar graduated from the University of Pittsburgh with a degree in Bioengineering and a minor in Mechanical Engineering, along with a certification in Innovation Design and Product Entrepreneurship. She founded her startup, noVrel, which focuses on integrating augmented reality into the operating room for neurosurgeons.

Sejeal has three years of experience working with startups across various medical fields, encompassing a range of roles from product development to go-to-market strategies.

For more information, please see her LinkedIn Profile.

Affiliated Consultants

Christopher Collins - Principal Consultant

Chris Collins has over twenty years of large-organization medical device experience, focusing on Class II and Class III vascular devices, and is very comfortable working with both large and small organizational structures in new product development and commercialization.

Chris began his career in Research and Development, focusing on the product development of peripheral vascular devices. During this time Chris was responsible for developing and implementing product test strategies, failure mode analyses, test methodology, and design transfer activities. Transitioning to Regulatory Affairs, Chris took on roles with increasing responsibility in Coronary product development and commercialization, including the planning and implementing Clinical Investigation of cutting-edge combination products within the United States – often managing several Pre-Submission interactions with the US FDA. Additionally, Chris managed multi-module, combination product PMA filings from planning through approval and the transition of Regulatory Responsibilities from one business group to another.

Chris also has extensive experience with Rest-of-World (ROW) product submissions, including working with local geographic partners to strategize, develop, and create filings for global regulatory authorities including Japan, Brazil, and European Notified Bodies. Chris has also led remediation activities to transition a broad product portfolio from the European Medical Device Directive to the European Medical Device Regulations.

Chris has worked closely with multiple functional disciplines including R&D, Quality Engineering, Manufacturing Engineering, Clinical, Legal, and Marketing staff. He has a deep understanding of the development, review, and approval of product development documentation, manufacturing and/or documentation changes (with a focus on regulatory reporting requirements), and promotional materials.

Chris pursues several passions outside of consulting including biking, hiking, photography, and golf. He is based in the wine country region of Sonoma County, California.

For more information, please see his LinkedIn profile.

Mary Wentorf - Principal Regulatory & Quality Consultant

Mary Wentorf is the Owner of Springboard Medical Device Consulting, LLC. Mary brings boundless energy and over 24 years of global experience developing cardiovascular & orthopedic medical devices. With a B.S. in Mechanical Engineering from the University of Minnesota, Mary has held various leadership roles in new product development, marketing, regulatory, quality, operations, clinical application engineering, and business development. Mary is honored to have lead the development of many implants, instruments, sterilization cases, sterile packaging configurations, and medical device software, holding over 40 patents (multiple filed globally for a total of 118). She is an expert in the development of total joints (hips, knees, shoulders) with a specialization in revision and endoprostheses, trauma and deformity correction (long bones, hand/foot, hardware and software), pacemaker/defibrillator leads with a specialization in heart failure therapies, catheters, single use and reusable surgical instruments, and sterilization cases. She is currently gaining experience in neurological drug delivery, small bore connectors, and pre-filled syringes. 

Most recently, Mary served as Chief Technology Officer at a start-up specializing in orthopedic medical devices for children where she was responsible for building product development, quality, and regulatory departments as well as responsibilities for surgeon compliance/relationship management and business development. Having worked at companies of all sizes, Mary is passionate about helping clients solve problems, navigate design controls, apply risk management principles, and bring products to market quickly with high quality standards. 

Common requests from clients include training and consulting on design controls and risk management; QMS establishment and optimization; regulatory strategy, pre-submission facilitation, and submission writing (US FDA and EU MDR); sterile packaging design and process validation strategy; post market surveillance set-up and optimization; design assessment and strategic recommendations; and business development strategy.   Mary lives in Warsaw, Indiana with her husband, two boys, and two dogs where she is an amateur backyard adventure enthusiast, elementary school Lego Robotics Instructor, as well as an advisor and guest lecturer for the Grace College Engineering Department. 

For more information, please see her LinkedIn profile.

Carrie Kuehn, Ph.D. - Principal Clinical Consultant

Dr. Carrie Kuehn is a talented medical device regulatory and clinical affairs professional with a diverse background and over 25 years of experience in research epidemiology, medical devices, regulatory and clinical affairs, and patient-focused policy.  In practice, Dr. Kuehn applies her expertise, leadership, strategic remediation skills, and broad medical device clinical-regulatory knowledge to address the needs of medical products companies and stakeholders across therapeutic areas.  Dr. Kuehn excels at taking complex, multidisciplinary problems and synthesizing them into a cohesive strategy.  She is particularly skilled at stepping into crises, supporting remediation efforts, conducting gap analyses, reorienting strategic plans, and bringing positive results out of fire-drill situations.

Carrie has worked as a regulatory affairs consultant for the medical device industry supporting pre-market submission activities (510(k), PMA, IDE and Q-sub engagements) and post-market clinical, regulatory, and compliance activities. Carrie has diverse industry experience in various therapeutic areas and particular expertise in cardiovascular, orthopedic, SaMD, and digital health medical device sectors. Carrie has successfully navigated complex responses to regulatory authorities in the U.S., EU, and Australia. She has a deep understanding of the clinical data necessary for AI/ML medical devices, requirements for validation and controls of bias, diversity and generalizability of data supporting AI/ML algorithms. Carrie has experience with FDA regulation of Class II, Class III, SaMD, Clinical Decision Software, and AI/ML medical devices. Carrie has led global multi-site post-market clinical research teams responsible for generating clinical evidence to support EU MDR submission and approval, and successfully reduced and closed questions in rounds of review under EU MDR. Carrie has remediated quality systems, QMS documentation, CAPAs, PMS systems and data, and 483 findings. She has also successfully communicated data to reduce recall classification, overhauled regulatory and clinical processes and procedures, and successfully implemented system improvements to ensure medical device clearance and approval in the U.S., EU, and beyond.  

For more information, please see her LinkedIn Profile.

Nicholas Nilo - Senior Regulatory Specialist

Nicholas is an experienced and accomplished Regulatory affairs specialist working in pre-market submissions for the EU and USA. Nicholas graduated from the University of Pittsburgh with a degree in Industrial Engineering. Working with companies from 8 to 80,000 employees, Nicholas has been exposed to working with all phases of the product development cycle. He has successfully achieved CE marking for Class III neuromodulation (spinal cord stimulation) and cardiac surgery devices over the past 4 years, including cleared remediation projects for legacy devices to meet EU MDR updates. He also has experience with a complete SaMD EU MDR submission. Nicholas has had success authoring US pre-market submissions including 510(k) submissions and a de novo.

Combining a technical background, strong communication, and an eye for detail, Nicholas has had great success working to meet business interests, regulatory needs, and the realities of production.

For more information, please see his LinkedIn Profile.

Melissa Hall, MS - Principal Regulatory Consultant

Melissa Hall is a seasoned medical device regulatory expert with over 10 years experience. The majority of her experience lies within the premarket space of the Food and Drug Administration (FDA). She has held various roles in the agency including lead reviewer, assistant director, consumer safety officer, and policy analyst. Her review expertise ranges across all premarket submission types, with specific expertise in the orthopedic space. As a consumer safety officer she served as an industry educator of the premarket regulatory processes, and as a policy analyst, she served as a regulatory expert addressing complex regulatory issues and ensuring laws, regulations, and guidances were applied consistently across the center.

Now serving as a consultant, she continues her dedication to advancing public health by assisting the medical device community in their efforts to navigate the complex regulatory process and strategy that best aligns with their business goals. She has developed regulatory strategies and submissions for a broad range of devices including SaMDs, hearing aids, orthopedics, dental, etc. She is an active presenter on various premarket topics at various conferences put on by the Advanced Medical Technology Association (Advamed) and the Regulatory Affairs Professional Society (RAPS), as well as, recently co-authored a chapter in the upcoming new release of the RAPS Fundamentals of Medical Device Regulations book.

Melissa obtained her bachelor's degree in biological sciences at the University of Maryland Baltimore County and her master’s degree in biomedical engineering from the New Jersey Institute of Technology (NJIT), while also serving as an assistant volleyball coach to the Men’s and Women’s Division I Volleyball teams at NJIT. A student-athlete at heart, she now enjoys playing recreational ice hockey, while also serving as a team manager for her kids’ sports teams. 

Melissa is the Founder and Principal Consultant of Statera Regulatory Consulting. For more information, please visit her LinkedIn Profile. 

Theodore R. Nicholson III, Ph.D. - Principal Consultant

Theodore has a PhD in biomedical engineering with over 14 years of experience in biological, chemical, and medical device product development. He spent the last 10 years navigating software design and development, regulatory, quality, risk, project management, clinical trials, and business aspects of medical device development projects in several regulatory environments. He has built teams across domains, led large cross-functional product development efforts, managed multi-site national clinical trials, and operated as an executive within the medical device space. Theo has worked in software as a medical device for 10 years in behavioral health, patient monitoring, remote patient monitoring, and critical care applications. His most recent experiences have been in the machine learning domain, applying the power of those analytical tools to complex diagnostic questions. During these efforts, he established cloud-based systems and performed cybersecurity risk assessment to inform design, development, and testing of medical devices. He has end-to-end software as a medical device experience.

His consulting firm, TRN3 Consulting LLC, also supports sustainable innovation in Healthcare, Energy, Agriculture, Water, and Housing Development. The main work centers underserved and underrepresented communities in the marketplace to close gaps and eliminate disparities that harm individuals in those communities. Theo enjoys helping projects that help people. Theo is a member of the external advisory committee at the Ohio State University Biomedical Engineering department and supports faculty programming as well as student mentoring.

For more information, please visit the TRN3 Consulting website or his LinkedIn Profile.

Deanna Najman, MS - Principal Quality Consultant

Deanna Najman has extensive worldwide regulatory and quality experience in medical devices including class III implantable devices.  She is experienced with ISO 13485 MDSAP, the new MDR, Cybersecurity, and UDI Labeling. She has experience in the areas of ophthalmology, cardiovascular, neurological, diabetes, and wound care.

She has performed many Investigational Device Exemptions (IDE's/clinical investigations), two original Premarket Applications (PMA) and numerous 510(k)s. Additionally, she has developed and implemented quality systems to comply with ISO 13485 MDSAP and other worldwide standards. She has represented firms to the FDA and third party auditors leading Corrective and Preventative action programs, as well as process validation experience. She has her lead auditing certification and has been involved in numerous FDA and Notified Regulatory Body audits representing clients.

She is also versed in design control, having led design teams from the feasibility to product launch providing team leadership in customer requirements, risk assessments and design transfer.

Deanna has been working in Regulatory Affairs and Quality Assurance for 18+ years in the medical device industry. Her clients include Fortune 500 as well as mid-size and start-up companies. She holds three engineering degrees. She double-majored at the University of Michigan, Ann Arbor in Mechanical Engineering and Bioengineering and has a master's degree in Biomedical Engineering from the University of Southern California in Los Angeles. 

Deanna is also on the Board of Directors for Juvenile Diabetes Research Foundation where she is the research Information volunteer.

For more information, please see her LinkedIn profile.

Elliot Franz - Senior Quality and Design Consultant

Elliot Franz is grateful to have worked in the medical device industry for over 10 years.  He has degrees in Biomedical Engineering (BS, Bucknell University) and Electrical and Computer Engineering (MS, Temple University).  He is an ‘engineer’s engineer,’ a lifelong learner, and an experimentalist.  He began his career in product design and development and has held other positions including quality engineering, operations, and senior management.  

Elliot has primarily helped startup to midsize companies who design and manufacture Class I and II medical devices for the US, Canadian, and European markets.  He provides services in any combination of the following four domains:  Strategy and Leadership, Design, Quality/Regulatory, and Production/Operations. 

Elliot’s deep knowledge of quality management and regulations coupled with his design and operations experience put him in an excellent position to help his clients produce safe and effective medical devices.  He is a skilled communicator who can bridge the gap between engineering, business, and quality/regulatory.  He is comfortable with any scope, whether narrow or broad, and always strives to deliver quality work.

Elliot lives near Pittsburgh, Pennsylvania with his family.  He enjoys many outdoor activities, especially hiking with his family and dog, mountain biking, skiing, and gardening.

For more information, please see his LinkedIn profile.

Former Consultants and Interns

Nilo Medical Consulting Group would like to thank the following former consultants and interns for their work. These outstanding students have since graduated and the NMCG team wishes them well in all of their future endeavors!