Posts categorized as“Western Region”

Lindsey

5 Tricks that reduce low volume supplier lead times

Negotiating low volume lead supplier times is not without challenges. Vendors can look at low volume quantities or lower dollar value orders as less priority or of importance to fulfill.  Adding to this challenge, Just In Time (JIT) delivery is often used to meet on demand client sales orders. The pre-planned anticipated lead time in […]

Vanessa Del Castillo Faria

How to extract good value from your medical device supply chain

Manufacturing low volume, high complex medical device products requires sourcing highly customized and expensive parts. This makes it hard to extract good value from your medical device supply chain. While high-volume production enables economies of scale, low volume custom-made production involves fewer parts to absorb product development, tooling and production equipment costs.

Dana Trousil

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

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 […]

Susan Bantroch

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

Keep 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 […]

Alexandra Reid

Bringing Consistency to the FDA’s Inspection Process

Leveling the Playing Field with recent Draft Guidance   Review and Update of Device Establishment Inspection Processes and Standards, a draft guidance document from the FDA, establishes uniform processes and standards for FDA’s Inspection Process of both domestic and foreign medical device firms.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 […]

Virginia Anastassova

510(k) submission: 9 Tips for success

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 […]

Hannah Rusak-Gillrie

How to turn patient imaging data into functional 3D models

Patient 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 […]

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