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In this episode of Medtech Snapshot we discuss strategic supply chain strategies with medical device supply chain and manufacturing executive Jeff Brown. Key points in this discussion include addressing situations similar to China and Taiwan, solutions to hedge yourself against such global challenges, including but not limited to supplier risk, back-up capacity and vertical integration. Need help sorting through your supply chain and or contract manufacturing challenges? Learn more about Square-1 Engineering's capabilities as it relates to all things manufacturing engineering: NPI, tech transfer, pilot manufacturing, process development and improvement, supply chain management, etc. Click HERE to learn more.
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EU MDR/ IVDR PROPOSED PUSH1/25/2023 DID YOU KNOW On January 6, 2023 the European Commission, a political and regulatory steering committee consisting of a group of 27 Commissioners, known as 'the College', adopted a proposal to give more time to device OEMs to certify medical devices under EU MDR to mitigate the risk of shortages. The proposal, which now needs to be adopted by the European Parliament, could push out MDR requirements several years. Higher risk devices such as pacemakers and joint implants would have a shorter transition period till December 2027, whereas lower risk devices, such as syringes or reusable surgical instruments wouldn't be until December 2028.
One of the biggest business challenges I run across today impacting both large and small companies alike is bandwidth issues – too much work, not enough ‘resources’ to get the job done.
A lack of resources in any business is a problem, indeed. Whether those resources are people, materials or relationships (supply chain), having the right number of resources to handle your needs while also being able to get a head requires both strategic forethought and action. |
About the AuthorTravis Smith is the founder and managing director of Square-1 Engineering, a medical device consulting firm, providing end to end engineering and compliance services. He successfully served the life sciences marketplace in SoCal for over 15 years and has been recognized as a ‘40 Under 40’ honoree by the Greater Irvine Chamber of Commerce as a top leader in Orange County, CA. |
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