Beep…Boop…Bop: Redesigning the Sounds of Medical Devices
Human Factors and Usability professionals have the unique understanding of how healthcare professionals can and do use medical products in a real-world setting. The art and science of developing medical devices that patients can properly interact with and...
read moreWorking with Laboratory Benefit Managers: Tips & Best Practices
Working with Laboratory Benefit Managers: Tips & Best Practices Mitchell I. Burken, M.D.Associate Medical DirectorGeneticseviCore Whether you’re in the early stages of working with Laboratory Benefit Managers or are have more experience, understanding how...
read moreFDA Innovative Clinical Trial Designs Launch
The U.S. Food and Drug Administration (FDA) is attempting to modernize the drug development process. A new phase of clinical trial designs was recently announced in an effort to help bring new therapies to patients as quickly as possible. The new pilot...
read moreThe Future of Ozone Sterilization
As medical technology continues to evolve, so do medical device sterilization methods. Alternatives to traditional sterilization processes, including ozone sterilization are beginning to change the landscape of the medical device sterilization industry. A recent...
read moreThe Importance of Labeling
Labeling issues continue to plague the medical device and pharmaceutical industry. The FDA recently released a statement regarding a medication recall as a result of a labeling error. CBS News reports, “Accord Healthcare Inc. is voluntarily recalling one lot of 12.5...
read moreGary Safsten – PACCAR Inc
Semi-Annual Medical Device Supplier Quality Conference: Speaker Interview
read moreYadwinder Sidhu – Inteva Products
6th Semi-Annual Medical Device Supplier Quality Conference: Speaker Interview
read moreMike Kijewski – Medcrypt
2nd Annual Medical Device Cybersecurity Risk Mitigation Conference: Speaker Interview
read moreIvan Cirino – Ethicon
2nd Annual Pharmaceutical Manufacturing Execution Systems Conference: Speaker Interview
read moreSusan Kelley – Spartan Race, Inc.
Executive Leadership Support Forum: Boston: Speaker Interview
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FDA opens door to multiarm, multicompany clinical trials
One of the best things that can happen to clinical trials is to make the process smoother. That is exactly what the FDA is trying to do. They have outlined how developers of drugs targeting rare pediatric diseases to streamline their clinical development programs and...
read moreBreakthrough Devices Program: Draft Guidance to Implement 21st Century Cures
On October 25 of this year, the FDA published a draft for guidelines that would help expedite access to medical devices intended for treatment or diagnosis of life-threatening or irreversibly debilitating disease conditions. Industry experts have 60 days to submit...
read more3D printing could expand medical device regulation: Here’s how
3D printing is changing and saving lives. The FDA is working on creating guidelines to better regulate submissions for 3D-printed medical devices. These guidelines gives the FDA regulators’ thinking on device design, testing of products for function and...
read moreCVS Health to buy Aetna for around $69 billion
CVS Health is set to acquire Aetna for roughly $69 billion in cash and stock. This deal is a first for the industry and is aimed at fending off challenges in retail and health care. This deal will create the first triple threat that includes CVS’s...
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