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Over the past several years, medical device OEMs have shifted focus to their core competencies, becoming more dependent on contract manufacturers. When selecting a CMO, it’s important to look at organizational alignment, senior leadership engagement, program management, and processes in place to manage risk.
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DFM discussion must be concise and backed by both historical data and up-to-the-minute insights. It is critical that OEMs see and understand the benefits of taking time to build a mold or create automation more robustly because, although time is being lost up front, long-term savings and higher annual volume production can be realized.
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In a recent webinar, SMC experts discussed best practices and tips across a range of topics, including program management, automation, and secondary services. Meredith Canty, Senior Director of Drug Delivery; Charlotte Ward, Director of Program Management; and Ryan Moran, Director of Automation Engineering, answered audience questions after the webinar.
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Biologics and other targeted therapy techniques are creating opportunities for innovative device solutions that meet the needs of specific patient groups. As these therapies often require low annual volumes, the associated device manufacturing strategy must also fit commercial expectations, even at those volumes.
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Quality is often defined in manufacturing as a measure of excellence or a state of being free from defects. Complex products and supply chains present plenty of opportunities for failure, especially when new products are being developed. Discover key ingredients to robust and advanced quality planning that are essential to quality in contract manufacturing.
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Utilizing automated manufacturing is a common CMO strategy that can deliver quality, cost savings, and scalability to the manufacture of drug delivery devices. To exploit these advantages, it is vital to understand automated manufacturing’s strengths and limitations, as well as how to optimize collaboration with manufacturing partners.
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