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 […]
From Zero to Six Million – Using a Component Management Process to Scale Up Manufacturing of Drug Delivery Devices
Drug delivery devices constitute one of the most rapidly growing segments of the medical device manufacturing market. Makers focus substantial R&D efforts on designing delivery mechanisms for new and existing drug formulations. However, even good initial designs can’t guarantee that all the parts for these devices can be manufactured correctly and assembled consistently, with few […]
Blueprint for Sales Certification: 7 Elements of a Successful Program
Establishing a sales certification program is not simple or cheap, and few companies do it well. This whitepaper dives into 7 elements of a successful sales certification program which include: Enabling sales reps a platform for perfecting their delivery Certification without the challenges of logistics or connectivity Sharing best practices & objection handling Leveraging this […]
The 6 Sciences of Medical Micro Molding
The medical micro molding industry is still fairly young, but is rapidly growing and evolving. Being aware of shifts in trends and changes in technology helps to see where and how the next major innovations and breakthroughs will occur. In the medical device world, it’s often the smallest parts that carry the greatest importance relative […]
The Design Differences of a “Medical-Grade” Foot Control
As medical device OEMs know, a product designed for the medical market is fundamentally different from one intended for industrial use. This is also true for a foot control. From the bottom pads to the mating connector, the design requirements for a medical-grade foot control are significantly different from those of an “industrial-grade” unit.
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