4th International Conference on Neurology and Brain Disorders

September 09-11, 2021

September 09 -11, 2021 | Virtual Event
INBC 2017

Michael Luedtke

Speaker at International Conference on Neurology and Brain Disorders 2017 - Michael Luedtke
Johnson & Johnson, United States
Title : Importance of medical device usability studies and image analysis measurement techniques

Abstract:

I nternational medical device development and proper design control methods require formative and summative validation studies. In the past, some company usability studies were conducted with employees and submitted for Regulatory clearance for Medical Devices. Recently, FDA has released guidance documents that clarify such studies are no longer accepted. This is also apparent in similar international regulations and stresses the importance of these validation / usability studies.These studies when coupled with image analysis techniques these qualitative provide measurable quantitative data that can be used to improve medical devices with neurologist, neurosurgeon and health care professional input. Close collaboration with industry, clinicians and researchers is very important to evaluate devices for such use errors prior to launch to avoid product improvement via device recalls.

Audience take away:

The neurologists, surgeons and neuro health care professionals in the audience may not often get a view as to how industry validates their medical devices. They may not also be aware of the new International Regulatory requirementsand the methods usedby Industry. The audience will have a quick review of the regulatory requirements as well as see very tangible examples(use errors observed using medical devices as well as image analysis techniques). This will be a great tour into howneurosurgeons could partner with industry and how we needthis information to develop and improve medical devices prior to launch. As employees may no longer be used as representative populations (as clarified in latest FDA guidance document), this partnership is very critical.

By demonstrating how surgeons could better partner with industry, they can better understand how to help and ensure their feedback is captured in such medical device design studies (in early voice of customer phases) or by helping with summative usability studies (last step before launch) that will ultimately drive better or improve medical device design.

In summary, this talk would highlight the most important International Regulatory Impact to usability studies in device development, image analysis technique examples in combination with surgeon / health care professional usability study outcomes that helpedquantify use errors and help medical device designers to design such use errors away prior to launch.

Biography:

Michael Luedtke started his Johnson & Johnson career within J&J Consumer and Personal Products Worldwide (Skillman, NJ) as an intern in 1998. In 2001 he served as a Senior Scientist where he developed and used innovative methodologies to conduct clinical trials that substantiated consumer product safety and effectiveness for the New Technology, Models and Methods and Scientific Affairs departments. He then transitioned into a program manager role managing cross enterprise research teams for Ethicon-Endo Surgery, Ortho Dermatologics and OraPharma and led medical device, imaging and pharmaceutical research projects. In 2010, Michael transitioned to Codman Neuro where he served in various Clinical Research roles of increasing responsibility working on peripheral nerve stimulation (neuromodulation). He then transitioned to serving on product lifecycle and new product development project teams within the Codman Neuro neurosurgical and neurovascular divisions. In November of 2012, he transitioned to Medical Affairs where he served in increasing roles of responsibility and currently serves in the Medical Affairs Medical Operations Life Cycle Management (LCM) as Manager LCM. Michael achieved an MS in Biomedical Engineering (Materials – Tissue Optics) from Drexel University and a BS in Bioengineering (Instrumentation) from Syracuse University. His research and efforts have led to various poster and podium presentations at international meetings, peer reviewed journal publications and a book chapter.

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