Question
One of the themes I come across regularly with my medical product manufacturing clients is uneven skills in investigation and determining root cause through a rigorous and adequate Root Cause Analysis (RCA). In some cases, it is newer team members wh...
Paula Rutledge
Executive Medical Device Recruiter | 30 Years Medical Device | Executive Headhunter |
June 2018
Wow. The CDC says that 1 in 4 people will die of heart disease. 610,000 people in the U.S. alone. As someone who lost a friend very young to undiagnosed heart disease, this shocks and disturbs me. For a relatively low cost burden, the ECG is a simple...
In this value-based healthcare world, providers put you in a bucket. Is yours: • An innovation delivering high-value outcomes sufficient to justify a higher price and margin • A commodity product cutting cost without reducing performance? I hadn't th...
When UK-based EnXray, makers of the first low-energy X-ray sterilization tech, needed £400,000 to scale its manufacturing to hit 2018 sales projections, it turned to Crowdcube. "We're 72% to our target raise with 201 investors," states EnXray co-foun...
When UK-based EnXray, makers of the first low-energy X-ray sterilization tech, needed £400,000 to scale its manufacturing to hit 2018 sales projections, it turned to Crowdcube. And fantastic-looking carbon-fiber wheelchair manufacturer Carbon Black i...
We are prepping to manufacture Medical Sterilization Machines for surgical tools prep and post surgery sterilization, and would be interested in learning the standard that should be applied in the final design.source: https://www.linkedin.com/groups/...
If you do business in Europe, I heartily suggest you familiarize yourself – and quickly – with the changes in MDR 2017/745 and MDR 2017/746. See http://bit.ly/EU-MDR-Labelling-Compliance The EU Medical Device Regulation (MDR 2017/745 & MDR 2017/746) ...
In this corner, the Surviving Sepsis Campaign (SSC), a Society of Critical Care Medicine and European Society of Intensive Care Medicine collaboration "committed to reducing mortality and morbidity from sepsis and septic shock worldwide." See . And i...
"Engineers who design and develop new devices are always telling me they hate design controls," Greenlight Guru co-founder Jon Speer tells me. "They say, 'Why are you talking to me about design controls?' Because without tight design controls, how do...
It depends, my market access and reimbursement go-to person Elizabeth Brooks said in this video interview: https://medgroup.biz/evidence. She says, "Our clients tend to fall into one of three traps. 1 - "We don't need any data." We're a 510(k) and di...
