Medical Devices and Biomedical Engineering

Kimberly K. Cameron, Ph.D., P.E.
Senior Consultant
Phone: (949) 540-7000
kkcameron@engsys.com
 

View Capability Sheet

Rapid advancements in technology and medicine continue to redefine the healthcare industry. Medical device manufacturers, healthcare professionals, and the legal and regulatory communities strive to keep pace with these changes without compromising their ability to deliver and/or ensure product safety and performance. 

Specific Capabilities

ESI offers a range of Medical Device and Biomedical Engineering services to assist clients with medical device and biomaterials projects, including product and process design, regulatory compliance, product testing, safety assessments, failure analysis, and risk mitigation.  We have consultants with extensive experience in pharmaceutical and medical device manufacturing and testing standards, and can help clients ensure that products and facilities apply industry best practices, and comply with Food and Drug Administration (FDA) and other regulatory requirements. 

In addition, ESI can perform a number of critical mechanical and tribological (wear) tests for orthopedic devices.  Available testing equipment includes:

  • Instron-Stanmore 4-station knee simulators for testing of total knee prosthesis in accordance with ISO 14243-1
  • AMTI hip wear simulators with 12 testing stations
  • AMTI orthopod pin-on-disk wear testing machine for orthopedic joint couples
  • Linear reciprocating pin-on-disk wear testing machine for hard-on-hard orthopedic joint couples
  • MTS Bionix fatigue testing machine with fixation jigs for testing of knee and ankle prosthesis
  • MTS single axis Mini-Bionix fatigue testing machine
  • Instron Model 1000 8-axis fatigue testing machine with multiple fixation jigs for testing of multiple types of orthopedic implants

ESI's testing facility and onsite manufacturing and machining equipment enable our consultants to produce customizable fixation jigs for the testing of unique devices.  

This equipment allows ESI to test the performance of medical implant materials and complete medical device components for total hip, knee, and ankle prosthesis.  ESI also has the ability to provide its expertise to the medical device industry as a third party testing facility, with ISO accredited equipment, for failure analysis and FDA 510(k) compliance. 

Multidisciplinary Expertise

At ESI, our in-house teams are comprised of professionals with deep domain knowledge in many key areas, including biomaterials, biomechanical engineering, material and mechanical engineering, and electrical engineering.  These consultants collaborate across disciplines, combining decades of industry knowledge and technical know-how to resolve complex technical issues. In addition, our consultants have hands-on experience using state-of-the-art laboratory, testing, and analysis equipment, and can perform ASTM and ISO mechanical and corrosion tests for many medical devices and materials.

Standards and Compliance

  • Facilitate medical device design, regulatory strategy development, and preclinical testing plans according to government standards.
  • Interpret FDA regulatory guidelines to help manufacturers with product submission requirements (e.g. Premarket Notification - 510k).
  • Assist medical device manufacturers with validating that processes comply with FDA requirements.

Product Development and Support

  • Investigate product and process issues, assess quality control, and provide other manufacturing/operational consulting services.
  • Procure equipment and qualify installation, operation, and processes.
  • Conduct testing of medical device explants for durability, corrosion resistance, and adverse biological responses.
  • Perform comprehensive failure analysis.
  • Investigate medical devices and pharmaceutical manufacturing operations, and perform contamination control where applicable.
  • Provide medical device recall management solutions and product liability technical support.

Failure Analysis and Liability

  • Conduct testing of medical device explants for durability, corrosion resistance, and adverse biological responses.
  • Perform comprehensive failure analysis.
  • Investigate medical devices and pharmaceutical manufacturing operations, and perform contamination control where applicable.
  • Provide medical device recall management solutions and product liability technical support.

Professionals in This Area

Name

 

Title

 

Email

 

Location(s)

Ahearn, Jennifer D.   Senior Managing Consultant and Director of Regulatory & Compliance-Pharmaceutical & Medical Devices   jdahearn@engsys.com  

Georgia

Alexander, Dale E., Ph.D., P.E.   Principal & Director of Materials   dealexander@engsys.com  

Illinois

Bajzek, Thomas J., P.E., CFEI   Principal & Director of Electrical Engineering   tjbajzek@engsys.com  

Illinois

Baron, Richard P., Ph.D., P.E.   Senior Managing Consultant & Manager of Dallas Operations   rpbaron@engsys.com  

Texas (Dallas)

Bigelow, Clifford C., P.E., CFEI   Senior Consultant & Manager of Missouri Operations   cbigelow@engsys.com  

Missouri

Bilancia, Louis F., P.E.   Senior Staff Consultant   lfbilancia@engsys.com  

Oregon

Brickman, Dennis B., P.E.   Principal   dbbrickman@engsys.com  

Illinois

Cameron, Kimberly K., Ph.D., P.E.   Senior Managing Consultant   kkcameron@engsys.com  

California

Duvall, Donald E., Ph.D., P.E.   Senior Managing Consultant   deduvall@engsys.com  

Illinois

Edwards, Dale B., P.E.   Senior Managing Consultant   dbedwards@engsys.com  

Illinois

Fortenbaugh, Dave, Ph.D.   Staff Consultant   dmfortenbaugh@engsys.com  

Florida

Garber, Mitchell A., M.D., M.P.H., M.S.M.E.   Senior Managing Consultant   magarber@engsys.com  

Georgia

Hayes, Michael D., Ph.D., P.E.   Senior Consultant   mdhayes@engsys.com  

Georgia

Hineman, Mark A., P.E., C.W.I.   Senior Consultant   mahineman@engsys.com  

Illinois

Knox, Erick H., Ph.D., P.E.   Principal & Director of Biomechanical & Safety Engineering   ehknox@engsys.com  

Illinois

Novak, Gary J., Ph.D., P.E.   Senior Consultant   gjnovak@engsys.com  

Illinois

Parrington, Ronald J., P.E., FASM   Senior Managing Consultant & Director of Industrial Services   rjparrington@engsys.com  

Illinois

Pederson, David A.   Senior Consultant   dapederson@engsys.com  

Georgia

Schmidt, Frederick E., Ph.D., P.E., C.E.F.   Senior Managing Consultant   feschmidt@engsys.com  

Illinois

Shah, Anand R., M.S., M.B.A., P.E.   Senior Managing Consultant   arshah@engsys.com  

Illinois

Smith, Jr., Kenneth M., P.E.   Senior Managing Consultant   kmsmith@engsys.com  

California

Spankie, Daniel R.   Senior Consultant   dspankie@engsys.com  

North Carolina

Stern, Amber Rath, Ph.D., P.E.   Senior Consultant   arstern@engsys.com  

North Carolina

Stevenson, Michael E., Ph.D., P.E.   President, Principal & Chief Executive Officer   mestevenson@engsys.com  

Georgia

Van Bree, Michael P.   Senior Consultant   mpvanbree@engsys.com  

Illinois