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.
The interview process was surprising to me when I applied to StarFish Medical for an administrative role six years ago. I was brought in for two rounds of interviews. In years past, I had only ever had a single interview with a company before being offered a position. Looking back on that now, I was naïve in believing that the company knew enough about me, and in turn, that I knew enough about them to accept a position.
The Conformité Européenne (CE) mark is a common sight on products in North America, and Europe. However the China Export mark and CE mark are easily confused, which is understandable because they look almost identical. This similarity is something which has been acknowledged by the EU parliament.
Designing a printed circuit board (PCB)? Is it for a prototype? I’m a Junior Electrical Engineer at StarFish Medical. This article summarizes some of the things that I’ve learned since I’ve been here. It is intended to serve as some words of advice to the novice PCB designer. The focus is on medical device PCB prototypes, but some of the information here is also applicable to more mature designs. For more PCB design best practices, check out these blogs from Kenneth MacCallum.