Medical Device Summit’s Supplier Controls & Quality Management Conference left attendees shaking their head in awe with the quality and volume of critical content presented by industry speakers. When Kim Trautman speaks along side Medtronic, Abbot, J&J, Edwards Life Science, BD and others there is a lot to be learned. The take-aways for the attendees were huge. Sponsors capitalized on the in conference interaction between and among attendees and speakers to learn about specific pain points in supplier controls and conducted many one on one meetings.

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Medical Device Supplier Controls & Quality Management Conference 2012

In this 5-minute video, Kim Trautman, FDA’s Medical Device International Quality Systems Expert, speaks with Sangita Viswanathan, Editor-in-Chief, Medical Device Summit, on managing internal suppliers; benchmarking; and tackling global supply chain challenges. Trautman, who has been recently named FDA’s Acting Associate Director-International Affairs asks the device sector to: 1. Pay attention to internal suppliers; “a supplier is a supplier even if they are part of the same corporate structure, and you still need soundproof terms of agreement under QSR;” 2. Look at some best practices followed by automotive, telecommunications and aerospace sectors for risk management and supplier controls, and adapt these for consistent, better quality results; and 3. Work with FDA which has number of initiatives for managing global supply chain integrity and quality, and have the assurances in place to understand your supplier, manage risk and ensure a good quality product.

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Kim Trautman at Medical Device Summit’s Suppler Controls & Quality Management Conference

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Kim Trautman at Supplier Controls & Quality Management Conference

John Rogers and his team at the University of Illinois, Champaign-Urbana have come up with a way to monitor the body electronically that really sticks. They have developed a small, flexible circuit device that sticks comfortably to the skin and is artfully camouflaged as a temporary tattoo. It can read a patient’s brainwaves, heart rate and muscle activity while they are going about their normal activity, making it possible to cut back on visits to the doctor’s office. Rogers envisions one day an implantable circuit that diagnoses and perhaps treats seizures.

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Electronic Tattoo Monitors Brain, Heart and Muscles

Considerations when preparing and submitting a medical device 510(k) application to the US Food and Drug Administration (FDA).

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Overview of the 510(k) medical device clearance process in the USA