Dana Trousil

First-to-Market Vs. robust commercialization: trade-offs, tips, and tactics

First-to-Market Vs. robust commercialization
Bringing your medical device to market involves a lot of trade-offs. First-to-Market Vs. robust commercialization process. Do you launch quickly with a minimum viable product? There may be significant post-launch changes in order to be the first to market.
Possible negative feedback from rushing to market may destroy any device adoption. Perhaps going through an extra spin or two to resolve potential manufacturability or production issues is warranted. Below are some trade-offs, tips, and tactics from our manufacturing and supply chain team that are worth thinking about.

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Susan Bantroch

Consider these 3 areas carefully when testing medical devices in a Biolab

Testing Medical Devices in a BiolabKeep your project on time, within budget 

Testing medical devices in a Biolab often requires changing locations from an engineering lab to a Biosecurity Level 2 (BSL2) BioLab that can facilitate specialized tests involving potentially dangerous microorganisms, tissues and biological fluids. Careful pre-planning is required for timely experiments to take place in BSL2 BioLabs. Poorly designed devices or tests can delay obtaining critical results, and create unnecessarily large bills.

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Alexandra Reid

Bringing Consistency to the FDA’s Inspection Process

Leveling the Playing Field with recent Draft Guidance

 

FDA’s Inspection ProcessReview and Update of Device Establishment Inspection Processes and Standards, a draft guidance document from the FDA, establishes uniform processes and standards for FDA’s Inspection Process of both domestic and foreign medical device firms. The FDA’s plan is outlined in a short, six-page document released March 29, 2019. The goal is to bring more consistency to the inspection process.

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Virginia Anastassova

510(k) submission: 9 Tips for success

FDA 510(k)A 510(k) submission is required in the U.S.to receive clearance to market almost all class II medical devices.  While the 510(k) preparation process is not as onerous as preparing a Premarket Approval (PMA), it has its own challenges and pitfalls. We recently completed a 510(k) submission and I’d like to share some of the wisdom and lessons learned from this experience.

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Hannah Rusak-Gillrie

How to turn patient imaging data into functional 3D models

functional 3D modelsPatient imaging data is a powerful and robust source for developing anatomically accurate and functional 3D models. Having an accurate representation of anatomy available to engineers and designers during product brainstorming and design is an invaluable resource. This blog outlines the process of creating 3D models, and innovative methods to use them throughout medical device development.

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Luke Mills

Maximizing Efficiency in a Switch Mode Power Supply

Switch Mode Power SupplyWhy spend time maximizing efficiency in a switch mode power supply? Higher efficiency switching regulators get you more bang out of your buck. In a world of mobile devices, minimizing power consumption is a must. Don’t waste power in the power supply. This blog looks at the sources of inefficiency one would find in a typical buck or boost style DC-DC converter.

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Kenneth MacCallum

Temperature Measurement and the Application of NTC Thermistors 

NTC ThermistorsWhen I say temperature sensors, you’ll likely think thermocouples. But today I’d like to discuss NTC thermistors. Medical devices regularly need to measure  temperature. Often engineers overlook or under-estimate the inherent challenges. Whether designing in thermal measurement and control capability or just temporarily instrumenting up a test rig, it’s worth thinking about how the device measurement is going to work.

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Astero StarFish

5 tips for a productive EMC lab visit

EMC Lab Visit
EMC (Electromagnetic compatibility) compliance is an essential requirement for all electronic medical devices. Usually, designers partner with EMC labs (certified testing) facilities in order to assess device compliance. In this blog members of the StarFish Electrical Engineering team share tips for a productive and successful assessment during your EMC lab visit.

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