I just returned from Boston BIOMEDevice, where I gave a Learning Lab presentation on electro-medical device basic safety and achieving compliance with 60601. For those who couldn’t attend, here are highlights from Day 1 of the Learning Lab event.
Last week I discussed Intellectual Property, Consumables Strategy, Value Chain and Margin, and Reimbursement, as part of a Proven Process for Medical Device Success and thorough new technology commercialization readiness review. This week we cover: Regulatory, Human Factors and Workflow, Technology Assessment, and Design for Manufacture.
Over the years, StarFish Medical has worked with a lot of entrepreneurial individuals and their ideas for exciting new medical devices. Our experiences led to the Pathfinder process, which assists the entrepreneur in gauging their new technology commercialization readiness. Part 1 of this blog touches on four areas typically investigated as part of a thorough […]
Medical device development is a fast moving, innovative field. President Ronald Reagan said: ‘If it keeps moving, regulate it.’ I mentioned in an earlier post that the best way to avoid waste is to consider Medical Device Regulatory Requirements at the outset of the project, rather than try to meet regulatory obligations when the design is […]
The Medical Device Directive is currently under review, in part due to the French Breast Implant scandal, and there has been much critical feedback to the EU over the change from ALARP (or ‘As low as reasonably practicable’) to AFAP (“As Far As Possible’ (AFAP)). We will have to see how this and other feedback […]
The Medical Device Directive is currently under review, in part due to the French Breast Implant scandal, and there has been much critical feedback to the EU over the change from ALARP (or ‘As low as reasonably practicable’) to AFAP (“As Far As Possible’ (AFAP)). We will have to see how this and other feedback […]
Zig Ziglar said “Some of us learn from other people’s mistakes and the rest of us have to be other people.” The aim of this article and my previous blog on Documentation Planning, Input, and Architecture tips is to try and prevent readers from being “other people”. Below are three Risk Management, Verification & Validation […]
I sometimes find myself in discussion with Entrepreneurs who have developed a novel prototype Medical Device and are ready for market launch, but the device documentation available is an electronic schematic, source code and a Google Sketchup of the enclosure. As a Regulatory Advisor, I explain they must follow a documented medical device development process; […]
Some companies experience problems getting FDA Regulatory Clearance using the 510(k) Pre-market Notification process. As a Product Development company, StarFish Medical’s focus is more on regulatory compliance than strategy. We believe it is important to consider Regulatory all the way through the development process, and not try to ‘bolt on’ compliance at the end. Here […]
We have already discussed the differences between Proof of concepts and Products in another post. This entry covers the stages in-between proof of concept and units out the door – how many steps to a final product?
We have been doing quite a lot of work for clients submitting their electrical devices for IEC 60601 Edition 3 electrical safety testing. For those unfamiliar, most users of medical devices would agree that mandatory electrical safety testing is a good thing before devices are allowed on the market. Now, 60601 Edition 3 takes this […]
Around 10 years ago, I set up a company with the entrepreneurial Professor from my PhD. After recruiting an MBA as chief executive and performing very many pitches, we eventually secured seed funding then series A funding to develop a novel medical device technology. The development was a new application of an existing technology and […]