Posts categorized as“Manufacturing”

Vahid Faridsaleh

Applying PFMEA efficiently to Medtech manufacturing process

Process Failure Modes and Effects Analysis (PFMEA) can be a powerful tool to identify potential failures in the manufacturing process of medical device, and help prioritize which failures should be improved first. However, the effort required to complete a PFMEA can take many hours, which costs money. Applying PFMEA efficiently will be addressed in this […]

Christine Park

Selecting wearable medical device adhesives

Understanding the Basics of Adhesives Selecting wearable medical device adhesives requires a solid understanding of the basics of adhesive. Sticking a medical device to skin is not as simple as it sounds. Numerous variables come into play such as the patient’s age, gender, race, diet, activity, skin condition, and climate. Other variables include the stretchability […]

Astero StarFish

StarFish year in review: Most clicked newsletter items of 2016

Our content reflects topics that interest and engage StarFish employees.  We encourage everyone to write, participate in videos, make public presentations and help our clients (current and future) and colleagues (current and future) learn about us and our work. Every month we get together over a lunch to see what got read, clicked, liked and […]

Dana Trousil

Off the shelf components in medical devices

When developing a medical device, it’s easier both in time and effort not to reinvent the wheel. Sometimes, off-the-shelf (OTS, or COTS – commercial off the shelf) components don’t meet the device needs, and usually these deficiencies are obvious. The problem arises when we unconsciously ask for more than the original widget design requires.

Dana Trousil

Prototype vs Production tooling

“What’s the difference between production tooling vs prototype?” and “What quality can I expect?” are often questions that I get asked from development or clients. The best answer begins with other questions: “What quality do you really need?”, and “How many are you making?”

Laura Meyer

Supplier Quality Agreement or Supply Agreement?

In the early stages of medical device development, it is usually sufficient to secure pre- production quantities through a simplified procurement cycle. A specification, a quote, a purchase order and a certificate of conformance —what other paperwork is needed? Why clutter up a simple, well defined process with other documents and paperwork?

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