Academic Credentials
  • Ph.D., Biophysics, Harvard University, 2002
  • M.S., Chemistry, Stanford University, 1997
  • B.S., Chemistry, Stanford University, 1996
Academic Appointments
  • Adjunct Associate Professor, Biomedical Engineering, Boston University, 2017-2018
  • Adjunct Research Assistant Professor, Biomedical Engineering, Boston University, 2009-2017
Professional Affiliations
  • Association for Diagnostics & Laboratory Medicine (ADLM)
  • Northeast Branch - American Society for Microbiology (ASM)

Alexis Sauer-Budge, Ph.D., is a principal scientist in Exponent's Biomedical Engineering & Sciences practice, focusing on in vitro diagnostics (IVDs), microbiology, biological contamination investigations, and contamination control for regulated products. Her expertise includes IVD technical due diligence, microbiological contamination consulting, cleaning and disinfection of reusable medical devices, microbial risk assessment, biological asset loss investigations, and expert support for litigation and insurance matters.

Dr. Sauer-Budge helps clients identify biological materials, determine their source and persistence, evaluate contamination and product quality risks, and address challenges involving pharmaceuticals, medical devices, biotechnology products, and consumer products. Her expertise is founded on interdisciplinary training in chemistry and biophysics and more than 25 years of experience applying microbiology, molecular biology, and analytical science to real-world product and manufacturing challenges.

Throughout her career, Dr. Sauer-Budge has led multidisciplinary teams of scientists and engineers in the development, evaluation, and investigation of diagnostic technologies, biomedical products, and manufacturing processes. She specializes in determining what biological materials are present, where they originated, how they behave in complex environments, and how they interact with products, surfaces, and materials. Her understanding of molecular structure-function relationships, microbial proliferation and persistence, contamination pathways, analytical characterization, and product design enables clients to address challenges involving diagnostics, contamination control, product quality, cleaning and disinfection, and biological risk.

Before joining Exponent, Dr. Sauer-Budge led the Biomedical and Biotechnology Group at the Fraunhofer Center for Manufacturing Innovation at Boston University, where she directed multidisciplinary teams of scientists and engineers developing diagnostic technologies, medical devices, laboratory automation systems, and biomedical instrumentation. She managed translational research programs spanning early-stage technology development through scale-up, manufacturing, and FDA readiness, helping clients bridge the gap between academic innovation and commercial products.

Earlier in her career, she worked at BioScale on the commercialization of a BioMEMS sensing platform for clinical diagnostics and food safety applications. Her doctoral research at Harvard University focused on single-molecule DNA sequencing technologies that later contributed to the development of nanopore sequencing platforms.

In Vitro Diagnostics Consulting

Dr. Sauer-Budge provides consulting support across the total product lifecycle for in vitro diagnostics (IVDs), from early-stage technology development through regulatory submission, commercialization, and postmarket investigations. Her experience encompasses molecular diagnostics, immunoassays, microbiology assays, sample preparation technologies, microfluidic systems, laboratory instrumentation, and bioanalytical methods.

Dr. Sauer-Budge assists clients with technical due diligence for acquisitions and investments, assay development and optimization, design and manufacturing investigations, regulatory strategy, and diagnostic test failure analysis. Drawing upon her background in chemistry, biophysics, and molecular biology, she evaluates the scientific principles underlying assay performance, including biomolecular interactions, surface chemistry, analytical sensitivity and specificity, and system-level design considerations. She works with medical device, biotechnology, and diagnostic companies to address technical, quality, regulatory, and litigation-related questions involving diagnostic technologies.

Microbiology, Biological Materials & Contamination Investigations

Dr. Sauer-Budge assists clients in investigating microbiological contamination events involving pharmaceuticals, medical devices, biotechnology products, consumer products, and laboratory environments. She helps organizations identify contaminating organisms and biological materials, determine contamination sources and transmission pathways, evaluate the extent and significance of contamination, and assess potential impacts on product quality, safety, and regulatory compliance.

Dr. Sauer-Budge's experience includes investigations involving bacteria, fungi, viruses, biofilms, mold, and human-derived biological materials, as well as environmental monitoring excursions, contamination control failures, and unexpected biological residues. Dr. Sauer-Budge applies microbiological, molecular biological, and analytical techniques to support source attribution, root-cause investigations, microbial risk assessments, and scientifically defensible decision-making in quality, regulatory, litigation, and insurance matters.

Cleaning, Disinfection & Contamination Control

Dr. Sauer-Budge helps clients evaluate strategies to prevent, control, and mitigate microbiological contamination in regulated products and manufacturing environments. Her work includes scientific assessment of cleaning and disinfection chemistries, contamination control programs, reusable and reprocessed medical device reprocessing, remediation approaches, and microbial risk assessments.

Drawing upon her expertise in microbiology, chemistry, and biological-material interactions, Dr. Sauer-Budge  evaluates factors that influence microbial survival, persistence, and removal, including biofilms, surface properties, disinfectant mechanisms, environmental conditions, and use-related factors. She helps clients assess whether cleaning and disinfection approaches are appropriate for their intended application, investigate contamination control failures, evaluate microbial risks, and develop scientifically supported contamination mitigation strategies for pharmaceuticals, medical devices, biotechnology products, and consumer products.

Microbial-Material Interactions & Antimicrobial Technologies

Dr. Sauer-Budge assists clients in understanding how microorganisms interact with materials, surfaces, products, and built environments. Her expertise draws on training in chemistry and biophysics, including the molecular and surface interactions that influence microbial adhesion, biofouling, persistence, survival, and removal. She evaluates factors affecting microbial behavior on materials, including surface chemistry, material composition, environmental conditions, and the presence of antimicrobial coatings or treatments.

Dr. Sauer-Budge supports the development, assessment, and investigation of antimicrobial technologies, contamination-resistant materials, and products intended to reduce microbial growth, persistence, or transmission. Her work integrates findings from laboratory studies, scientific literature, and real-world evidence to assess how experimental observations translate to practical use environments, recognizing that laboratory models cannot fully replicate the complexity and variability of real-world conditions. She helps clients understand the scientific basis for microbial persistence, evaluate the strengths and limitations of antimicrobial strategies, and address technical, regulatory, quality, and litigation-related questions involving medical devices, pharmaceuticals, consumer products, and biotechnology applications.

Technical Investigations, Insurance & Litigation Support

Dr. Sauer-Budge assists clients in investigating biological incidents, product quality issues, contamination events, and losses involving biological materials. She conducts root-cause investigations, evaluates scientific evidence, assesses causation, interprets laboratory findings, and helps organizations understand the implications of biological data for products, manufacturing operations, research activities, and commercial losses.

Dr. Sauer-Budge's experience includes investigations involving microbial contamination, biological materials, research laboratory incidents, freezer failures, and damage to biologics, drugs, vaccines, and other temperature-sensitive materials, as well as technical consulting in matters involving medical devices, diagnostics, and consumer products. Drawing upon her expertise in microbiology, molecular biology, chemistry, contamination investigations, and microbial risk assessment, she helps clients determine contamination sources, assess biological damage, evaluate competing technical explanations, and establish the most scientifically supported root cause of an event for regulatory, insurance, and litigation-related proceedings.