Dr. Stephen Coulter has areas of expertise in product development, design control, technology partnerships, product lifecycle management, and acquisition analysis. He is experienced in the development of manufacturing process controls and quality limits for critical product lines and has a global background in biomedical product, medical device, combination product, over-the-counter drug, consumer product, and environmental product companies ranging in size from startups to multi-billion dollar companies. He also successfully aligned development, quality, and compliance organization within a company to establish and sustain regulatory compliance to United States and International medical device regulations.

Christie Johnson is a Partner at Prodct LLC, providing customized advisory and infrastructure development for early-stage medtech startups in Risk Management & Quality Management Systems. She also serves as Director of Quality at myBiometry, a digital health company focused on asthma management and is a content expert for the NIH's RADx program (accelerating COVID-19 diagnostics). Previously, as the founder of Kasota Engineering, she helped dozens of startups and small medtech companies establish tailored quality management systems and risk management files. Her diverse experience includes roles at industry-leading companies such as GE Aviation, Hologic, and Sonablate Corp.

Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project Management Professional (PMP) certification. Having managed cross-functional teams to update designs of legacy products, Etienne understands the pain of following the Design Controls process in paper-based QMS environment. His expansive knowledge, experience, and passion with medical devices is evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high quality products to market.

Tanima brings 30+ years of experience in Medical Device Management and Hardware/Software Product Development assisting highly regulated organizations to design, implement and maintain agile management systems that comply with international standards and best practices such as ISO 13485, MDSAP, 21CFR820, EUMDD/MDR, ISO 14971, IEC 62304, ISO 27001 and AS9100D.Tanima leads remediation activities, coaches front room audit preparation, performs supplier quality audits with inspection reports and prepares procedures, technical dossiers and 510(k) submissions. Tanima has successfully transformed development & implemented systems for different global clients including drug-device combination products, computer-assisted medical device surgical systems, microgravity payloads and space systems; telemedicine and expert systems, and platforms compliant with global medical device quality systems and international regulatory approvals. Tanima’s passion is building and leading “Dream Teams” for creative problem solving to unblock development, pre-audit playbooks, clear warning letters, qualify dual sources, obtain critical regulatory approvals, launch commercialization and support sustaining engineering/PMS activities using iterative agile hardware/software development best practices.

Páll Jóhannesson, M.Sc. in Medical Market Access, is the founder and Managing Director of SMART-TRIAL by Greenlight Guru. Páll was previously the CEO of SMART-TRIAL where he led the team to create the only EDC specifically made for medical devices.

coming soon...

Wojciech is a Regulatory and Clinical Affairs Specialist with a strong scientific (MSc in Medical Biotechnology; PhD in Neurobiology), and Med-Tech consulting background. Throughout his career, Wojciech has been supporting both US and European medical device manufacturers, striving for compliance mainly with the requirements of the EU 2017/745 MDR. His clients ranged from small family companies, through startups to multi international corporations. Among others, Wojciech has been involved in establishment and management of Clinical Evaluation service delivery processes; provision of PMS/PMCF support; clinical/regulatory strategy definition and consulting,as well as delivery of numerous trainings and workshops.

Darwin Shurig, CEO of Shurig Solutions, Inc, understands that people are the greatest asset at any company and the key qualities that growth companies need to grow market share while enhancing their positive culture and team environment.  He has a clinical background as a Respiratory Therapist of over 30 years including 12+ years of sales, business development, marketing and negotiations experience within medical device, diagnostics, distribution, ventilation, and sleep therapy, 8 years of sales leadership, 3 years of operations and extensive experience in negotiations and contract management before entering the entrepreneurial world of talent management.

He founded Shurig Solutions, Inc. in 2015 and is responsible for business development processes, contracting, and recruiting strategy, personally responsible for over $4 million in revenue generation while scaling a business that was paid $2.4 million in 2022 for the value it brings.  Darwin has created the SSI Educational Webinar Series, the SSI Executive Conversations Podcast, Candidate Prep Best Practices, and the TT Accelerant process.  Darwin was highlighted in the Creative Classics Book “The American Entrepreneur” published in 2020, was listed an MRI Top 10 Managing Partner for 2021, and SSI was ranked a Top 15 Office in 2022.  He has a heart for charity as SSI supports 4 independent charities and he is on the board of the MRI Charitable Foundation which supports Shriner’s Children’s Hospital.

Mark DuVal, J.D., is President & CEO of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His practice includes providing strategic regulatory advice, developing compliance programs, designing and implementing sophisticated marketing programs, counseling on reimbursement matters, conducting sales training and interfacing extensively on behalf of companies with the FDA with relation to product approvals and clearances, clinical trial negotiations, approvals, policy arguments, appeals, etc. Prior to founding the firm, Mark was general counsel for 3M Pharmaceuticals and Drug Delivery Systems working both domestically and internationally. He was on assignment for 3M Health Care Systems, Ltd. In Europe based out of the United Kingdom. He then worked at Medtronic in Corporate Compliance for FDA, Anti-kickback, False Claims Act, HIPAA & HITECH, and other advice related to the FDA-regulated industry. Mark earned his Juris Doctor from the William Mitchell College of Law where he served as executive editor on the law review, and his Bachelor of Arts in Public Administration from St. Cloud State University. Mark has served on various boards including the Minnesota BioBusiness Alliance, Minnesota Biosciences Council, The Food and Drug Law Institute and has been a former Chairman of the Minnesota State Food, Drug, and Medical Device Section of the Minnesota State Bar Association. He is also on the Board of Advisors of the Masters in Regulatory Affairs Services program at St. Cloud State University. Mark is a frequent national speaker and writer on issues relating to product approvals/clearances; combination products, product advertising and promotion, Anti-kickback and False Claims Act (reimbursement) matters.

Carolyn Guthrie serves as the Vice President of Regulatory Affairs and Quality Assurance for Kapstone Medical. She has been in the Medical Device industry in quality and regulatory functions for almost 20 years, working for and with both large corporations and start-up companies with a single employee. The types of devices she has worked with has varied from In Vitro Diagnostic devices to Orthopedic, Dental, Software, and Kitting, Packaging, & Sterilization devices. Carolyn has experience globally, with a focus on North America and Europe, in both the premarket and postmarket quality and regulatory functions, including premarket submissions (510(k) and CE Mark), as well as day-to-day operations in quality assurance and quality systems. Originally from South Africa, Carolyn is now based out of South Florida. She holds a BS in Biochemistry and Microbiology and an MS in Human Cell Biology from the University of Cape Town in South Africa and an MS in Regulatory Affairs (International) from Northeastern University in Boston, MA. In addition, she holds a RAC (Regulatory Affairs Professional Society Certification) for the US.

Umesh Soni is currently leading the Unannounced Audit Program in TUV SUD America while supporting the special operations team as a “Senior Auditor”. He is also a Local Certification Reviewer, Technical File Reviewer and Lead Auditor for MDSAP, MDR, MDD, ISO 13485 and ISO 9001. He successfully led various process improvement and six sigma projects in TUV SUD. With 15+ years of healthcare industry experience, Umesh has areas of expertise in Auditing, Regulatory Compliance, Quality Engineering, Regulatory Affairs, Quality Systems, Product Life Cycle Management, Design Development, Manufacturing Process, Sustenance, Remediation, and Post Market. Umesh possesses graduate degrees in MBA in healthcare administration and MS in regulatory affairs. Umesh loves traveling and exploring new places.

Anders Mærkedahl has 10+ years experience within MedTech market access and market dynamics. He has successfully introduced and driven access and sales strategies for both European and US markets. Prior to joining NHTA, Anders Mærkedahl was Global head of Health Economics & Market Access at Ambu A/S, where he established the global HEMA team and successfully integrated health economics and market access into product development (stage-gate model), clinical development plans, and launched excellence plans.