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Medical Device Design and Infection Prevention: What Do Manufacturers Need to Know?

Previously Recorded On June 15, 2021

A growing concern for healthcare providers is the expanding universe of drug-resistant microbes and the hospital-acquired infections that can result in complications, mortality, and morbidity. Infection prevention is critical for medical device manufacturers, as medical devices have been known to harbor drug-resistant microbes and transmit device-related infections – even after the devices have been appropriately disinfected. FDA has addressed the infection rates associated with reprocessed devices like duodenoscopes by placing new and additional obligations on manufacturers to verify that new product designs reduce the contamination rate. In this installment of Medmarc’s webinar series, Dr. Howard Loree of Exponent will address:

  • Causes of Medical Device Infection
  • Design Strategies for Infection Prevention for Single Use and Reusable Devices
  • Device Use and Environment
  • Design Verification for Infection Prevention

 

Howard Loree. II, Ph.D. | Manager| Biomedical Engineering & Sciences | Exponent

Dr. Howard Loree has over 25 years of diverse R&D experience in the medical device industry and a hands-on aptitude across the complete product development life cycle in both startup and growth stage companies. He has developed highly innovative surgical and interventional products for mechanical circulatory support, vascular access, peripheral vascular, neurovascular, spine, and ophthalmology applications. Dr. Loree’s consulting activities have focused on cardiovascular devices and include technology assessment, product design optimization, design verification & validation (V&V) testing, medical device health risk assessment (HRA), post-market regulatory support, and assistance with post-market regulatory/compliance inquiries.

Dr. Loree is a recognized expert in the development of rotary blood pump systems for implantable and wearable cardiovascular applications. This includes his role as Senior Scientist / Manager of Research at Thermo Cardiosystems / Thoratec (now part of Abbott) in starting and leading the HeartMate III program which commercialized a highly successful ventricular assist device (VAD) product. As Principal Staff Scientist at ABIOMED, he contributed to the regulatory approval and ongoing innovation of the Impella VAD product line. Most recently, as Vice President of R&D at Flow Forward Medical (now part of Artio Medical), Dr. Loree led the development of a novel device that rapidly dilates peripheral veins for use in creating reliable and durable arteriovenous fistula (AVF) vascular access sites for hemodialysis.

Dr. Loree has direct experience in leading projects from initial concept through in vivo feasibility, intellectual property (IP) development, design requirements, human factors analysis, failure mode and effects analysis (FMEA), design freeze, technology transfer from product development contractors, design V&V testing, and preparation for first-in-human trials. His personal technical accomplishments include raising over $4.5M in NIH funding for medical device development; planning, executing, and reporting preclinical studies to rapidly establish in vitro and in vivo feasibility; and supporting successful FDA submissions including IND, IDE, HDE, 510(k), and PMA.

Dr. Loree’s education includes B.S. and M.S. degrees in Mechanical Engineering from MIT as well as a Ph.D. in Medical Engineering from the HarvardÔÇÉMIT Division of Health Sciences and Technology. At MIT, his coursework and research focused on design, biomaterials, fluid mechanics, and medical sciences. He also completed a postdoctoral research fellowship in cardiovascular biomechanics at the Brigham and Women's Hospital, Harvard Medical School.

 

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