Why do some teams consistently meet their schedule, cost, and quality targets and others do not? There are libraries full of answers, but two will be discussed that are critical for effective teams: 1) make sure all team members know the company’s Product Development Process and 2) know which deliverables all team members must provide to each other.
As the cross-pollination of the molded electronic and medical components industries continues, the products in each industry are becoming much smaller and much more complex. Toolmakers, molders, suppliers and the OEMs of medical components that incorporate electronics must all have a firm understanding of the ideas, processes, expectations and standards of both industries in a collaborative effort to produce the highest quality component-level parts at the lowest viable cost.
With the help of a committed management team, a zealous company wide SDWT champion, dedicated team leaders/cheerleaders, and most importantly, participation of everyone on the shop floor, Farmington, CT-based Connecticut Spring & Stamping (CSS), is well on its way to meeting its ambitious goals, just two years after launching the initiative.
Requirements traceability is seen to yield a more predictable outcome at deployment, and responds to an increased demand for sound monitoring and management techniques during development, particularly between project phases. Appropriate automation can ensure that requirements are shown to be in compliance across the entire software development cycle, and demonstrates how a combination of tools and best practices can ease the implementation and maintenance of software development for medical devices.
Broncus Invests In Its Future: Innovative Medical Company Turns to the Cloud to Simplify the Document-Intensive Due Diligence ProcessJune 12, 2012 7:06 am | by Dave Fleming | Comments
For Broncus Chief Operating Officer Gary Kaplan, pursuing funding requires the management of a large number of documents which often need to be customized for each investor involved in due diligence. For example, the recent request from just one potential investor included 120 items, many of which were unique to that company’s needs. With requests coming in constantly, Kaplan found himself overwhelmed by the sheer volume of documents he needed to keep track of on a daily basis.
Ballbar analysis is a proven method for determining machine tool capability, and is the most practical, convenient and comprehensive tool for assessing the contouring accuracy of CNC machines. Ballbars have been commonplace at precision machining operations for more than 20 years, but a Midwest-based medical device manufacturer, is showing how the latest wireless ballbar technology makes a big difference in doing fast capability checks on small machines, as well as establishing a benchmark on machines' volumetric accuracy.
In medical imaging devices, large quantities of video imaging data need to be transferred from image sensor to image processor while maintaining high levels of electrical isolation so the sensor won’t shock the patient. The high-speed digital data transmission channels between the sensor and image processor require high-levels of isolation while transferring data at up to 100Mbaud for real-time displays.
There is a lot of talk about cloud computing today, and its exponentially growing presence among enterprise technology, particularly Product Lifecycle Management (PLM). While PLM “in the cloud” is available today, its adoption can be slow. Customers are having a difficult time deciphering when, how and even whether to use PLM in a cloud. With the type of sensitive information that is managed in PLM, there has been some apprehension about moving to the cloud. Adoption is slowly gaining momentum as more customers see the available options and advantages.
Portable automated external defibrillators (AEDs) are showing up regularly in places where large groups of people congregate, like airports and sports stadiums. This huge increase in the number of portable AEDs has not been driven by governmental regulation, but by the overwhelming evidence that they save lives.
Many modern medical devices are composed of high-tech materials such as metallic alloys or synthetic plastics. Their production may require the use of various agents to aid in the manufacturing process or produce contaminants that require later removal. These devices must be clean to ensure patient safety, and to ensure the device will continue to function as intended. Listed here is a five step process to help keep contaminants out and ensure cleanliness.
It was the scientist Lord Kelvin who said, "When you can measure what you are speaking about, and express it in numbers, you know something about it; but when you cannot measure it, when you cannot express it in numbers, your knowledge is of a meager and unsatisfactory kind.” So, if you are among those in the medical device industry who are struggling to keep DFM alive and well within your organization, or you plan to kick off a DFx initiative, this article is for you.
Rising product complexity, intense market pressures and compliance to industry standards present major challenges for medical device developers. In order to stay competitive, organizations must implement tight coordination between hardware and software engineers to optimize product quality. This is especially true when controlling costs and meeting tight time lines. IBM Rational offers a solution.
There’s good news available to patients who are in a hospital bed. Horizontal Computing System (HCS) has combined a standard hospital table with a patented laptop stand. This stand is unique in that it allows an ergonomically correct posture for the patient. The stand is adjustable to set desired angle. An adjustable locking plate secures 98% of laptops on the market. It offers laptop users an option they’ve never had before–comfort.
Question 1: How are innovative molding techniques enhancing the design capabilities of medical device manufacturers?