One of many crucial steps a single-use medical device takes on its journey from concept to commercial product is sterilization. Ethylene oxide gas sterilization, in particular, is one of the most efficient and effective ways of deactivating bacteria and other potentially dangerous living microbes from medical devices; however, manufacturers must take care to control and […]
3 Steps to Increase the Accuracy and Speed of Your Next Medical Device Recall
Recalls in the med-tech industry aren’t going away. In this white paper, you’ll find proven strategies to increase the efficiency of your recall strategy. These have been developed through our experience working with several of the largest med-tech companies in North America, who have told us that this method is “changing the way all recalls […]
The Case for Real-World Evidence (RWE) in Medical Device Development
Medical Devices are used in the real world every day, so shouldn’t they be tested in the real world? You would think so. But the FDA hasn’t necessarily been of that mindset — until now. Per FDA regulations, testing has to be conducted under supervised clinical trials, which have pre-designed protocols. When most think of […]
New Study Reveals How Medical Device Companies Can Earn Trust and Drive Revenue Growth
To meet the needs of the triple aim and help improve operational and cost efficiencies, hospital executives are looking for manufacturers to move beyond products to become problem solvers. With this in mind, medtech companies can deliver end-to-end solutions hospitals need, an opportunity worth $44 billion in the U.S., to help them transform the way […]
How to Write a Great Monitoring Report
Writing monitoring reports is an important responsibility. A well-written monitoring report tells the story of your clinical trial to the FDA and helps facilitate inspections. However, this important task doesn’t often get the attention it deserves. Between scheduling visits, traveling and conducting the visits, it can fall down on a monitor’s priority list. IMARC has […]
Micro Molding with Bioabsorbables: Not Your Average Thermoplastics
For micro medical components, there is a wide variety of materials to choose from and many new micro medical applications are relying on bioabsorbable materials because the materials dissolve or absorb into the body, eliminating the need for additional surgeries and minimizing concerns about adverse effects. Across the board with plastics, the rules are different […]
Keep Device Costs Low With Early Engineering Involvement
Engineering expertise plays a central role when working to meet the challenging needs of medical device and instrument companies. CSS (Connecticut Spring & Stamping) engineers engaged early with the team at Aragon Surgical. One focus was on streamlining the device production processes. The experience that CSS engineers brought to the table allowed for good collaboration, […]
Gain new perspective into the heightened scrutiny of medical device E&L
Recent feedback from several regulatory agencies has demonstrated increased scrutiny of medical devices for aflatoxins and other chemical species in the Cohort of Concern (CoC). At Jordi Labs, we’re offering new ideas on how to best manage this scrutiny of medical device E&L. The white paper and case study feature detailed information on: Aflatoxin detection […]
Surgical device development: New insights from the operating room
Successful surgical device development is dependent on teasing out, sometimes unknown, needs and is best achieved through direct contextual research. This is especially true for devices to be used within the acute environment of the operating room. With the emergence of robotic technologies, the dynamics within the operating room is changing. In robotic surgery, there […]
New Requirements for Medical EMC: IEC 60601-1-2 Edition 4
Plan now to ensure your medical devices comply with new EMC requirements by the December 2018 effective date. Since the development cycle can be 2-3 years, it is important to understand the new IEC 60601-1-2 EMC 4th Edition standard now when designing medical devices. To provide you guidance on these important changes and improve your […]
How to Ramp Up Bioabsorbable Production While Decreasing Piece Part Price
When OEMs prepare to increase production volume of a micromolded component, many focus on multi-cavitation tooling as a strategy to reduce piece part price. While increasing cavitation may be a cost-effective approach for higher volumes of simple thermoplastic parts, it is typically not the best approach for micromolded parts, especially those that are bioabsorbable, or […]
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