If you’re reading this, chances are you have a great idea for a medical device and you’re starting your design. You probably have an electrical element to your design. As tempting as it is to start ordering parts and tinkering, there are a few preliminary documents you can create to help you choose the right parts. Eventually you’ll need a design that must pass the requirements of IEC 60601-1.
The FDA Regulation of E-cigarettes aims to fill a technology regulation gap. Whether it’s the FAA and recreational drones or the USDA and the latest strain of genetically modified corn, widespread use of new technology is often followed by new regulation. And regulators have long struggled to keep pace with the seemingly endless stream of innovation that enters society. It’s not necessarily new technology itself that instigates regulation but rather the refinements that allow it to become widely available to the general public.
The past decade has seen vaporizers and e-cigarettes become widely available and while these products are capable of delivering nicotine in the form of smoke-like vapor, they technically have not met the definition of a “tobacco product” and therefore have been unregulated. Until now that is.
StarFish engineers Sal Sanci, Dean Addison, Mike Sanders and Nigel Syrotuck explore the pros and cons of popular Digital Health communication technologies over a series of blogs on the subject. This blog examines Digital Health communication technology cost and deployability for medical devices.
Is Device Generated Data part of your medical device plans?
We live in a digital era, and if you are in the medical device design and development business, it may be wise to think digital health. There is an undeniable shift from stand-alone technology to integrated systems even for devices with specialized functionality. Granted, devices with unique diagnostic or therapeutic functionality still have a place in the market place, but those capable of uploading data into a server, the cloud, or even directly into an electronic health record are more attractive to hospital and tertiary care buyers.
Sorting through the alphabet soup of the many standards that apply during medical device development can be daunting. This blog gives an overview of one of the more important ones: IEC 60601-1. The first installment covers Scope and Normative References. Part 2 covers detailed descriptions of the sixteen sections.
The point of a PMO (Project Management Officer) is to have somebody responsible for all of the actions a company does in project management. The PMO makes sure Project Manager (PM) practices are consistent and there is the right balance of relationship management and technical management. Are we cutting to the chase at the right times, digging deeper at the right times and having a consistent approach to client focus while getting the product right throughout the organization?
As a junior technical project manager, my job is to support senior project managers by monitoring and controlling longer-term projects with large teams. I also manage shorter-term projects with smaller teams. During my first year at StarFish Medical, I have worked on over ten projects with a wide variety of technical focuses and team compositions. I collect and maintain data on project budgets, schedules and tasks in order to help our teams predict and respond to challenges.
What’s the best way to motivate medical device teams?
As the medical device design and development landscape shifts quickly under our feet, so does our thinking surrounding work and how to get the best results. What used to be the best way to motivate your medical device team may not apply any more.
Wouldn’t it be nice if every time you tried something new it went perfectly on your first attempt? Since this is rarely the case, risk management is a key element to incorporate in your innovation process and an excellent skill for any project manager. Here are my five tips to managing innovation risk:
Project managers constantly strive to bring projects to a successful completion under challenging timelines and within a strict budget. We work with our clients to define what success is to them, not just for the project we are working on, but their program goals as well.