Crystal has been in the MedTech industry for over 20 years, with 10 years focused on medical devices across all major therapeutic areas. She has done extensive risk assessment work on respiratory devices, permanent implants including orthopedics, drainage catheters, and neurotransmitters, along with a variety of absorbable medical devices including sutures and wound dressings.

Crystal started her career in the pharmaceutical research space working on grants for Pfizer and the US Department of Agriculture (USDA). This work was focused on analytical chemistry method development and study design.

Crystal has a Bachelor’s degree in Biomedical Engineering and a Master’s in Pharmacology/Toxicology. In 2021 she passed the American Board of Toxicology (ABT) exam to become a board-certified toxicologist and joined the Society of Toxicology (SOT) as a full member.

CORE COMPETENCIES

• Developing biological evaluation plans and reports for biological safety assessment of medical devices in compliance with the ISO guidance documents for regulatory submissions
• Developing toxicological risk assessments of extractables/leachables testing on medical devices in compliance with the ISO guidance documents for regulatory submissions
• Developing gap analysis documents to ensure previously performed biocompatibility studies comply with the most the recent regulatory requirements and provide biological significance of differences that may be observed
• Working knowledge of FDA and EU MDR regulation expectations along with other global medical device regulations
• Interacting with clients on technical issues related to biocompatibility and chemistry testing
• Serving as a project manager, including coordination of client expectations and associate workload for successful project completion
• Study Directing, including maintaining GLP compliance of routine preclinical biocompatibility studies (ISO-10993 series, MHLW, USP, EP), interpretation of testing results and observations, and assessment of impact of unexpected circumstances
• Analyzing and interpreting of non-volatile compounds by Ultra Performance Liquid Chromatography Ultra-Violet Mass Spectrometry (UPLC-UV-MS)
• Working knowledge on all other lab techniques including:
  • Gas Chromatography Mass Spectrometry (GC-MS)
  • Inductively Coupled Plasma Mass Spectroscopy (ICP-MS)
  • Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES)
  • Fourier Transform Infrared Spectroscopy (FTIR)
  • Ion Chromatography (IC)

RECENT PROJECTS

• Toxicological Risk Assessment (TRA) on a device intended to be implanted in the skull bone based on the newly released ISO 10993-17 guidance document
• Specially designed toxicological assessment of two different mask components of a CPAP machine to validate a new disinfection process
• Biological Evaluation Plan (BEP) for a new to market device intended to deliver interventional and diagnostic devices into the human vasculature

PUBLICATIONS

• Analysis of Soy Natural Products and Esterase Enzymes for Drug Development; Jurkiewicz C.; Master’s Thesis Presentation; 2011.
• Determination of Esmolol and Metabolite Enantiomers within Human Plasma using Chiral Column Chromatography; Lei Fang, Crystal Bykowski-Jurkiewicz, Jeffery G Sarver, Paul W Erhardt; J Chromatogr B Analyt Technol Biomed Life Sci.; 2010 Sep 15; 878(26):2449-52.
• Rapid and sensitive HPLC assay for simultaneous determination of procaine; Mugunthu R Dhananjeyan, Jill A Trendel, Crystal Bykowski, Jeffrey G Sarver, Howard Ando, Paul W Erhardt; J Chromatogr B Analyt Technol Biomed Life Sci.; 2008 May 15; 867(2):247-52.
• Catalytically Active Peptidylglycine α-Amidating Monooxygenase in the Media of Androgen-Independent Prostate Cancer; Jill A Trendel, Nicole Ellis, Jeffrey G Sarver, Wieslaw A Klis, Mugunthu Dhananjeyan, Crystal A Bykowski, Michael D Reese, Paul W Erhardt; J Biomol Screen; 2008 Sep;13(8):804-9.
• Simultaneous determination of procaine and para-aminobenzoic acid by LC-MS/MS method; Mugunthu R Dhananjeyan, Crystal Bykowski, Jill A Trendel, Jeffrey G Sarver, Howard Ando, Paul W Erhardt; J Chromatogr B Analyt Technol Biomed Life Sci.; 2007 Mar 1; 847(2):224-30.
• Rapid and simultaneous determination of capecitabine and its metabolites in mouse plasma, mouse serum and rabbit bile by high performance liquid chromatography; Mugunthu R Dananjeyan, Jidong Liu, Crystal Bykowski, Jill A Trendel, Jeffrey G Sarver, Howard Ando, Paul W Erhardt; J Chromatogr A; 2007 Jan 5; 1138(1-2):101-8.