Nicholas Christiano
Naples,FL
Summary
Dynamic leader with a proven track record at Nelson Laboratories, driving market strategy within a given segment. Expert in cross-functional collaboration and customer relationship management, achieving significant market share growth while enhancing biosafety offerings across the US, EMEA and Asia. Skilled in strategic leadership and market analysis, ensuring alignment with industry standards.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Global Segment Lead – Biological Safety
Nelson Laboratories, LLC
Salt Lake City, USA
10.2023 - Current
- Identify Nelson Labs’ total addressable market for the Medical Device Biosafety segment, as well as identify adjacent capabilities that expand that addressable market.
- Identify Nelson Labs’ existing Biosafety oriented offerings and formulate ways to enhance definition, customer understanding, and promotion.
- Lead and develop the global market Biosafety strategy for Medical Device, including: Market share growth targets, Geographical prioritization of opportunity, Prioritization of opportunity based on value and probability to win, Investment required and expected ROI, Facility and testing capability plans, including harmonization across sites, New offering development and lifecycle leadership.
- Lead competitive intelligence efforts to support strategy and merger/acquisition considerations.
- Serve as the Biosafety industry SME to support cross functional decision making and broad-based business strategy.
- Maintain a working knowledge of industry standards and regulatory requirements.
- Build and maintain strong cross-functional working relationships across Sotera Health and the individual business units.
- Establish metrics and monitor segment results and deviations from plan, with corrective actions.
Senior Sales/Business Development Manager – E&L Medical Devices
Nelson Laboratories, LLC
08.2018 - 10.2023
- Provide consulting expertise for biological evaluation and assessment in accordance to ISO 10993: Biological Evaluation of Medical Devices, and domestic/international regulations for international medical device manufacturers;
- Manage 3.5 Million+ budget in testing services for medical device, pharmaceutical and drug delivery manufacturers.
Co-Owner
Fast Lane Drive
Salt Lake City, Utah
04.2025 - Current
- Co-lead the development and growth of the Utah chapter of Fast Lane Drive, an exclusive automotive and lifestyle community bringing together enthusiasts, founders, executives, and collectors
- Curate premium driving experiences, social gatherings, and destination events that blend performance driving, networking, and lifestyle culture
- Build and nurture a high-trust member community focused on relationships, shared experiences, and long-term engagement beyond the cars
- Oversee strategic partnerships with luxury brands, venues, sponsors, and philanthropic organizations to elevate member value and event quality
- Drive chapter-level strategy including membership growth, brand positioning, and regional expansion opportunities
- Lead event planning and execution logistics, including route curation, venue selection, vendor coordination, and member communications
- Champion philanthropic initiatives and charity-driven events, aligning the automotive lifestyle with meaningful community impact
Multi-Unit Owner Operator
Restore Hyper Wellness + Cryotherapy
Naples, USA
07.2019 - Current
- Restore is the leading retail provider of wellness services in the United States; Helping thousands of customers every day achieve their goals around sports performance, pain management, recovery, beauty and overall wellness; Wellness modalities include Cryotherapy, IV Drip Therapy, Hyperbaric Oxygen Therapy, Infrared Saunas, Compression Therapy, and Red Light Therapy.
- Own and operate 7 studio locations throughout Southwest Florida.
Co-Founder, President and Principal Consultant
Intrinsic Medical Group, LLC
Naples, USA
02.2017 - Current
- Provide consulting expertise for biological evaluation and assessment in accordance with ISO 10993: Biological Evaluation of Medical Devices, and domestic/international regulations for international medical device manufacturers;
- Support regulatory approval for medical device manufacturers regarding biocompatibility and biological patient safety of medical devices, combination products and container enclosures;
- Consult on best practices regarding biocompatibility evaluation, sterilization solutions, device terminal cleaning processes and reusable medical device validation for medical device manufacturers.
- Intrinsic Medical Group provides solutions that are both sustainable and backed by sound scientific evidence helping to ensure medical device patient safety. The Intrinsic Medical Group approach aims at advancing medical device safety utilizing industry knowledge, experience and regulatory tested approaches to evaluating medical device patient risk.
Senior Biocompatibility Specialist – Sterilization Sciences and Biological Safety
Arthrex, Inc.
Naples, USA
01.2014 - 08.2018
- Manage testing strategy for biological evaluation and assessment in accordance to ISO 10993: Biological Evaluation of Medical Devices on an international scale encompassing all regulatory requirements across vast markets around the globe;
- Specialize in and provide development/design support to Orthobiologics, Shoulder/Elbow Arthroscopy and Arthroplasty, Distal Extremities, and VET Systems design teams;
- Responsible for fully understanding indications and surgical techniques for new product introductions/changes to ensure proper assessment of biological safety and patient impact;
- Lead and manage team of Biological Safety Specialists as necessary to support biocompatibility, toxicology, and sterilization projects and initiatives;
- Develop and manage internal programs with a global perspective on biological safety risk assessment, test plans/strategies, test parameters and methods through understanding of methodologies in accordance with ISO 10993, FDA Guidance and global regulatory requirements;
- Represent the end user in the development and creation of quality/patient safety material supporting new product development including design inputs and risk assessment mitigation;
- Developed and implemented medical device extractables/leachables chemistry program to determine the toxicological risk associated with the clinical use of medical devices;
- Regulatory compliance with emphasis on US, APAC and EMEA markets by providing support to regulatory affairs professionals in efforts to further streamline product registration with global notified bodies;
- Regularly travel (~20-30%) throughout the US, Europe, and Asia for supplier business/product development, auditing, and conference speaking opportunities;
- Support in sterilization assessment/validation of EtO/Gamma terminally sterilized medical devices;
- Manage 8$ MM annually in sub contracted testing between third party testing laboratories and Arthrex;
- Evaluate and optimize biocompatibility procedures and protocols in development for in-vitro testing, including global round robin activities;
- Designed and implemented toxicological risk assessment program to ensure medical device clinical safety;
- Actively involved with the international communities and industry partners to reduce in-vivo animal testing models associated with the biological safety of medical devices;
- Co-development of advanced biocompatibility testing strategy minimizing the amount and reliance on in-vivo animal model testing to ensure patient safety of devices and instrumentation;
- Designed and developed studies utilizing mesenchymal human stem cells in efforts to more appropriately understand cellular ingrowth with novel biomaterials.
- Arthrex is a global medical device company and leader in medical education in orthopedics. Pioneering the field of arthroscopy Arthrex has developed over 12,500 innovative products and surgical procedures to advance minimally invasive orthopedics.
Medical Technician/Lab Associate
NeoGenomics Laboratories
Fort Myers, USA
06.2012 - 01.2014
- Delivered expert analysis of comprehensive oncology testing menu including Cytogenetics and FISH testing;
- Collaborated with board certified pathologists and specialty-trained cancer genetic professionals;
- Managed Cytogenetic and FISH projects for all AML/MML research and development related projects;
- Responsible for keeping up to date documentation upheld to GLP standard practices for all routine laboratory testing;
- Held accountable to Quality Control (QC) equipment, chemicals, solutions, and instrumentation in all labs;
- Served as assessor for all patient sensitive information (PSI) to validate that testing was carried out efficiently and accordingly.
- NeoGenomics Laboratories is a specialized oncology reference laboratory providing the latest testing technologies, global/tech-only options, interactive education to the pathology community, and a complete spectrum of diagnostic services in immunohistochemistry.
Lead Research Associate
Florida Gulf Coast University
Fort Myers, USA
01.2009 - 09.2013
- Supervised five (5) undergraduates and managed daily schedules and responsibilities in regards to multiple grant funded research projects including Investigating the temperature and pH dependence on the catalytic activity of Histidine Ammonia Lyase;
- Prepared and maintained laboratory provisions including undergraduate lab set up/tear down;
- Designed and managed research studies within the academic toxicology section and reported findings/status to department chair;
- Managed laboratory operations for those labs pertaining to analytical chemistry and toxicology.
- Florida Gulf Coast University office of undergraduate research manages grant-funded opportunities in research provided by both local and federal agencies including the National Aeronautics & Space Administration and the Department of Defense, all in part to keep research as an integral part of the educational process at FGCU.
Education
Master’s Degree (M.S) - Pharmacy, Pharmaceutical Sciences, Minoring in Clinical Toxicology
University of Florida College of Pharmacy
Gainesville, FL01.2018
Graduate Certificate - Clinical Toxicology
University of Florida College of Pharmacy
Gainesville, FL01.2017
Master’s Degree - Business Administration (MBA) with concentration in Interdisciplinary Studies
Florida Gulf Coast University Lutgert College of Business
Fort Myers, FL01.2016
Bachelors of Science Degree - Biology (B.S.), Minoring in Chemistry
Florida Gulf Coast University
Fort Myers, FL01.2013
Skills
- Market strategy development
- Regulatory compliance
- Customer relationship management
- Strategic leadership
- Cross-functional collaboration
- Market analysis
- Leadership development
Certification
- ISO 9001/13485 Medical Device Focus Lead Auditor, ASQ
- ISO/IEC 17025 Lead Assessor, ANAB
- Clinical Toxicology, University of Florida
Quality Regulatory Focus
- Biocompatibility Project Management
- B-2-B development with critical suppliers/labs
- Medical device development risk analysis
- Biologics/VET, Shoulder Arthroscopy, Trauma, and Arthroplasty medical device design support
- GMP’s, ISO, FDA, International standards knowledge and requirement consolidation
- International & domestic supplier auditing
- ISO 10993/13485/17025 Compliance
Publications
- Christiano, N., Rollins, T., Turley , A., & Parker, C. (2025). ISO 10993-1 FDIS Updates: What the Risk-Based Approach, Particulates, and Contact Time Changes Mean for Medical Device Teams. https://www.nelsonlabs.com/iso-10993-1-fdis-updates-what-the-risk-based-approach-particulates-and-contact-time-changes-mean-for-medical-device-teams/
- Coleman, K. P., Grailer, T. P., Mcnamara, L. R., Rollins, B. L., Christiano, N. J., Kandárová, H., Jong, W. H., Preparation of irritant polymer samples for an in vitro round robin study., Toxicology in Vitro, 10.1016/j.tiv.2018.01.018, 2018
- Jong, W. H., Hoffmann, S., Lee, M., Kandárová, H., Pellevoisin, C., Christiano, N., Haishima, Y., Coleman, K. P., Round robin study to evaluate the reconstructed human epidermis (RhE) model as an in vitro skin irritation test for detection of irritant activity in medical device extracts., Toxicology in Vitro, 10.1016/j.tiv.2018.01.001, 2018
References
Available upon request
Organizations
- American Advancement for Medical Devices
- ASTM International
- Society of Toxicology (SOT)
- American Society for Cellular Biology
- Project Management Institute
Presentations
- ISO 10993-1 FDIS Updates: FAQ from the Panel Q&A, Live Webinar, Nelson Labs LLC, 10/3/25
- ISO 10993-1:2025: What to Expect. MDM West 2025, MedTech Theater, Anaheim, California, USA, 02/05/25
- Today’s Medical Device Regulatory Landscape: What you need to know., FMMC 2019 Annual Meeting, St. Petersburg, Florida, USA, 05/14/19
- ISO 10993 and MDR Changes: What you Need to Know., MDR Workshop, Warsaw, Indiana, USA, 02/19/19
- Biological Evaluation of Medical Devices: Solutions to Changes in Regulatory Environment, San Jose, Costa Rica, 01/24/18
- Medical Device Packaging and Sterilization Methods Proven to Withstand Regulatory Scrutiny, Society of Biomaterials, Minneapolis, USA, 03/16/17
- International Regulatory Submissions: Best Practices., World Biomaterials Congress, Montreal, CA, 05/20/16
- Medical Device Packaging and Shelf Life: China FDA Medical Device Reviewer Group, Shanghai, China, 03/23/15
- Evaluating Medical Device Biocompatibility: China FDA Medical Device Reviewer Group, Beijing, China, 03/25/15
Accomplishments
40 Under 40, Gulfshore Business Class of 2023
Affiliations
Franchise Advisory Council Co-Chair, Restore Hyper Wellness 2023-2025
Timeline
Co-Owner
Fast Lane Drive
04.2025 - Current
Global Segment Lead – Biological Safety
Nelson Laboratories, LLC
10.2023 - Current
Multi-Unit Owner Operator
Restore Hyper Wellness + Cryotherapy
07.2019 - Current
Senior Sales/Business Development Manager – E&L Medical Devices
Nelson Laboratories, LLC
08.2018 - 10.2023
Co-Founder, President and Principal Consultant
Intrinsic Medical Group, LLC
02.2017 - Current
Senior Biocompatibility Specialist – Sterilization Sciences and Biological Safety
Arthrex, Inc.
01.2014 - 08.2018
Medical Technician/Lab Associate
NeoGenomics Laboratories
06.2012 - 01.2014
Lead Research Associate
Florida Gulf Coast University
01.2009 - 09.2013
Master’s Degree (M.S) - Pharmacy, Pharmaceutical Sciences, Minoring in Clinical Toxicology
University of Florida College of Pharmacy
Graduate Certificate - Clinical Toxicology
University of Florida College of Pharmacy
Master’s Degree - Business Administration (MBA) with concentration in Interdisciplinary Studies
Florida Gulf Coast University Lutgert College of Business
Bachelors of Science Degree - Biology (B.S.), Minoring in Chemistry
Florida Gulf Coast University