Latest From CVRx Inc.
"All-hands-on-deck" has been the policy pursued by the US industry association AdvaMed in recent times, as it has sought to play its part in promoting user-friendly, responsive and transparent regulation and market access for medical and digital health care technology. AdvaMed chair Nadim Yared believes that, with one or two noteworthy exceptions, there is more to come in 2019 from a largely improving medtech ecosystem globally.
AdvaMed's next board chair will be Stryker CEO Kevin Lobo, who will fill the leadership role beginning next March, when current chair Nadim Yared's two-year tenure is over. Lobo pledged to to work to improve diversity in industry.
The AdvaMed chairman and CVRx CEO spoke to Medtech Insight from the floor of the Pennsylvania Convention Center at this year's MedTech Conference. The discussion focused on the industry's push for a breakthrough reimbursement pathway, the impact of US-China tariff wars and the industry's answer to challenges from grassroots patient groups on device safety, among other challenges and priorities.
Boston Scientific, Edwards Lifesciences, Baxter Used CMMI To Measure Their Manufacturing Capability. Here's What They Said About The Experience
Quality, compliance and regulatory officials at the three large device firms – along with their peers at Steris and CVRx – open up about appraisals conducted at their facilities under a voluntary US FDA pilot program that uses Capability Maturity Model Integration (CMMI) to measure the capability and maturity of their manufacturing sites. Along with providing a step-by-step walk-through of the assessments, the officials explain how a CMMI appraisal is nothing like a typical regulatory audit. They also talk about the types of benefits they're seeing (hint: cost-savings, and better manufacturing capability and quality), and how they network via monthly conference calls linked to the pilot. Also: Baxter Healthcare explains why it made its own maturity model, and how it plans to eventually replace the homemade tool with CMMI at all its facilities.
The third of a multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity, and what it means for the medical device industry.
- Implantable Devices
Surgical Equipment & Devices
- Minimally or Less Invasive
- Therapeutic Areas
- North America
- Parent & Subsidiaries
- CVRx Inc.
- Senior Management
Nadim Yared, Pres. & CEO
John Brintnall, CFO
Philippe Wanstok, Chief Commercial Officer
Joseph DuPay, VP, R&D & Operations
Tom Moore, VP, Market Dev.
- Contact Info
Phone: (763) 416-2840
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Minneapolis, MN 55445
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