Well it’s here… IEC 60601-1-2 Ed 4:2014 is now in full force. The initial reaction to a change – significant or otherwise – to most regulatory requirements is … DARN IT… just when I finally got the hang of this thing someone goes and changes it, yet again. And so it is. IEC 60601-1-2 4th … Continue reading IEC 60601-1-2 4th Edition: What is it and Why Do I Need to Know
I always thought that everything I needed to learn I could learn from The Simpson’s but recently I have had to turn to comics and superheroes to learn about designing a battery powered medical device. In this case I’m referring to Ironman. Tony Stark had an electromagnet implanted in his chest to keep pieces of metal shrapnel that were lodged in his chest from entering his heart and killing him.
For the past 12 years I have worked in the medical device industry where I have developed new and exciting products which help to improve patient care, and in many cases, save lives. It’s the kind of thing that makes you want to get up and go to work each day.
By David Orenstein, Product Development Engineer (EG-GILERO) It can be difficult sometimes to see the value in usability testing. As devices are developed they seem so simple to the engineering team developing them; or the complexities are so justified it wouldn’t make sense to do it any other way. Often it is true that the … Continue reading The Importance of User Feedback – 3 Misuses of Pen Devices
Expanding our human factors team & offering onsite cleanroom manufacturing and assembly was an easy decision and natural extension to our core competencies. Press Release
By David Orenstein, Product Development Engineer (EG-GILERO) Nowadays it is becoming more and more apparent that the FDA wants validated data demonstrating that the intended user can use a medical device safely and effectively. The FDA has four expectations of Device Design regarding usability1: “Conduct a comprehensive risk assessment” “Identify and mitigate risk, including all … Continue reading The Importance of Formative Data; a Medical Device Engineer’s Perspective
I may be a new engineer to the medical device field, but the discussion I’ve observed in the industry over the past few years indicates the landscape is changing quickly. Some examples of recent changes that we’ve already seen include the emergence of digital medicine, robotically assisted surgeries, additive manufacturing for patient-specific implants, and consolidation … Continue reading A Case for Placing a Higher Priority on Human Factors in Your Medical Device Design Process
Today we have Kristin Benokraitis, Director of Quality and Operations with EG-GILERO sharing her thoughts on the five biggest pitfalls of medical device startups. In my day-to-day job at EG-GILERO, I have had the opportunity to work on hundreds of projects with a wide range of clients who are looking to develop the next big … Continue reading EG-GILERO Says: The Five Biggest Development Pitfalls for Medical Device Startups
Today we have John Donohoe, Senior Product Development Engineer with EG-GILERO with some thoughts on a recent pertinent industry article. Each company approaches their product development process differently. Variations in the type of industry and the product itself have a major effect on how a company structures their development process. However, most companies aim to … Continue reading EG-GILERO says: Getting the Most out of Your Product Development Process
Today we have Pete Smith, Principal Design Engineer with EG-GILERO with some thoughts on finding the problems to solve. I have spent most of my working life designing products, first at IBM, designing computers and more recently it has been medical devices & drug delivery devices with EG-GILERO. There has always been the typical product … Continue reading EG-GILERO says: Let’s identify what is needed to be done.
It’s great to see actual hard data supporting what the EG-GILERO Says blog was created for; “answering that illusive question of how our processes can help our customers help the people who must use medical devices”. A survey, conducted by marketing analytics company Vennli, compiled results from more than 9,000 healthcare professionals. Vennli issued the … Continue reading EG-GILERO says…Know Thy Customer
EG-GILERO says…A Different Perspective on using Six Sigma in the manufacturing of medical and drug delivery devices
We reached out to Wade Stauffer, Plant Supervisor at our Asheboro EG-GILERO manufacturing location once again, to hear firsthand how his plant is incorporating the techniques and tools of Six Sigma into their operating and manufacturing process. While they are still creating the foundation of this new way of working, they’ve clearly had some wins. … Continue reading EG-GILERO says…A Different Perspective on using Six Sigma in the manufacturing of medical and drug delivery devices
We recently reconnected with Dave Crispino, a Senior Engineer in the Rochester location of EG-GILERO. He and a few others have been heading up the Six Sen$e Initiative, and we wanted to hear more from him on how this initiative got started, what it is intended to do, and how it’s being rolled out within … Continue reading EG-GILERO says…A Different Perspective on The Six Sen$e Initiative
The company has grown from the dreams of its founders to a company with design and manufacturing locations around the globe. EG-GILERO has reached a milestone this October, celebrating 15 years of business. The company has grown from the dreams of its founders to a company with design and manufacturing locations around the globe. Co-founder, … Continue reading EG-GILERO Celebrates 15th Anniversary
EG-GILERO says…A Different Perspective on the Manufacturing and Assembly of Medical and Drug Delivery Devices
We have yet another entry from an EG-GILERO expert in our ongoing series. This time we’re hearing from Wade Stauffer, Plant Manager at our manufacturing facility located in Asheboro, NC. This plant is one of our FDA Registered facilities with Class 7 & 8 Cleanrooms where we have injection molding and highly specialized assembly and … Continue reading EG-GILERO says…A Different Perspective on the Manufacturing and Assembly of Medical and Drug Delivery Devices
We’ve got another entry for you from our ongoing series with EG-GILERO experts. Today, we’re hearing from two men who are leading tremendous change within tooling and injection molding at EG-GILERO. Dave Crispino, VP of Engineering and Kurt Charland, Tool Design Manager. We’ll be hearing from them both about the changes they have implemented individually … Continue reading EG-GILERO says…A Different Perspective on Tooling for Medical and Drug Delivery Devices
EG-GILERO says…A Different Perspective on the Design & Development of Medical and Drug Delivery Devices
We’re back with the second entry in our ongoing series with an EG-GILERO expert. Today, we’re hearing from Todd Macy, Director of Research and Development in our Design and Development office located in Columbus, OH. Todd opened the Columbus office 2 years ago, and has been focused on developing medical and drug delivery devices ranging … Continue reading EG-GILERO says…A Different Perspective on the Design & Development of Medical and Drug Delivery Devices
We had a great time and an even better turn-out at the EG-GILERO Open House in RTP. Despite the threatening skies and occasional shower, we enjoyed seeing our clients and our neighbors for an evening of drinks, mingling and delicious Mediterranean food. This event was born out of an opportunity to show our prospective and … Continue reading EG-GILERO says…A Different Perspective on an Open House
On a beautiful Saturday morning on May 20th in downtown Raleigh, EG-GILERO was in full effect at The Wake County Great Strides Walk for Cystic Fibrosis (CF). Representing Angelica’s Angels North Carolina team, $26,958 was raised in one day walking in the fight against CF. The donations are still coming in, but even without them, … Continue reading EG-GILERO says…A Different Perspective on The Wake County Great Strides Walk
EG-GILERO says…A Different Perspective on Growing a Successful Medical and Drug Delivery Device Contract Design and Manufacturing Company
We recently spoke with Ted Mosler, Chief Technical Officer at EG-GILERO, for another entry in our ongoing series with an EG-GILERO expert. Because the company has experienced considerable growth over the past few years, we wanted to ask Ted about the approach he has taken to manage this growth while ensuring they are staying on … Continue reading EG-GILERO says…A Different Perspective on Growing a Successful Medical and Drug Delivery Device Contract Design and Manufacturing Company
Last entry, we introduced our blog. We also introduced the concept of providing a different perspective on the topics you expect to hear from us. Today we’d like to focus on the trends and newest developments in Mobile Device Design.