11 Lessons learned from medical device projects
June is the month of many university graduations. In the spirit of continuous education, we asked our writers to identify medical device project tips they’ve learned from on the job experience. Here...
View ArticleUnderstanding the effect of DC bias on capacitance
Multi-layer ceramic chip capacitors (MLCCs) are the most common capacitor found in modern electronics. MLCCs have many attractive features: low ESR, good capacitance-to-volume ratio, relatively low...
View ArticleTips for addressing DC bias effects in multi-layer ceramic chip capacitors
Last week my blog discussed a major drawback to multi-layer ceramic chip capacitors (MLCCs) that is poorly understood by even experienced engineers: DC bias effects on capacitance. So, now that we know...
View Article7 Tips for Balancing Cost and Feedback
Build an Input Pyramid to support your medical device development As a medical device designer, I see clients balancing cost and feedback in a daily struggle to decide when to get clinical feedback,...
View ArticleTips for using simulated fluids when testing medical devices
Designing equipment (medical or otherwise) is a complicated process. This complexity is increased when the equipment of choice must either come in contact with biological material, or function within a...
View ArticleUnderstanding the UOUP (User Interface of Unknown Providence) section of IEC...
From a regulatory standpoint the differences between IEC 62366:2007 and IEC 62366 -1:2015 are minimal, with all the same boxes needing to be ticked. However, it is clear from reading the documentation...
View Article3D-Printing Prototype Sheet Metal Parts
Prototype Sheet Metal Parts in 4 steps Sheet metal fabrication is an excellent method of making mechanical parts, especially support brackets. They tend to be cheap, light, strong, and easy to pack and...
View ArticleUnderstanding and preparing for MDSAP Medical Device Single Audit Program
Although initially they may be deemed to be more expensive and complicated, MDSAP audits will provide a more efficient way of ensuring compliance with QMS and at the same time, reduce the...
View Article5 Tips to effectively manage competence and training
The value of competence and training in developing and maintaining a quality workforce is well understood. Yet, many organizations struggle with providing, documenting, and evaluating the effectiveness...
View ArticleAreas to consider when preparing for MDR 2017/745
Start early to avoid surprises Europe’s medical device directive (MDD) is changing as a result of MDR 2017/745 published on May 5, 2017. The new regulations will come into full force in Q2 2020, after...
View ArticleHow to handle changes under the 21st Century Cures Act and device exemption list
The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them...
View Article3 Medical UX design differences compared to consumer UX design
It is up to the medical UX designer to thoroughly research their users, environment, and product to produce a user friendly medical device. This blog focuses on 3 Medical UX design differences between...
View ArticleHow procedural observations improve medical device design
I once observed simulated combat first responder training for military medics. I asked the leader (who was a retired army colonel and physician) if their students were making what seemed like basic...
View Article3 ways medical device sketching helps the design process
Sketching plays an important role as a tool or skill in the industrial design process. It’s an essential way to visualize ideas and draft basic layouts of the design for each direction chosen. It’s...
View ArticleDifferences between design in school and real world medical device design
When I finished my third year of Industrial Design studies at Carleton University, I felt like I had a good grasp of the whole thing. I had finished a good number of design projects, worked out my own...
View ArticleAvoid these 11 costly medical device development mistakes
There are lots of stories about FDA recalls where the FDA notes that if the vendor had followed the FDA’s approach, the recall could have been avoided. With that as our inspiration, our blogging team...
View ArticleComparing Consumer and Medical Design Control
If I was to describe design control for consumer vs medical design in sports terms, medical design would be cricket and consumer design would be ice hockey. That is to say medical devices use a slow,...
View Article3D Printed Medical Devices – Insight into the FDA Guidance on Additive...
3D printing – or Additive Manufacturing (AM) – offers new and exciting ways to integrate parts not only for prototypes, but for final products. It presents novel ways of thinking about design, as new...
View ArticleWhen should you use Open Source Software in Medical Devices?
Open Source Software (OSS) is software with a copyright license that includes the right to view and alter the source code and to distribute derivative works. Usually, OSS is available free of charge...
View ArticleManaging evolving requirements to improve medical device design
Very few first product realization versions meet the expectations of end users. That is normal and should be anticipated and addressed with “enterprise business agility.” Managing evolving requirements...
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