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Gene Sequencing Devices Are ‘Next Generation’

November 21, 2013 3:10 pm | by Jeffrey Shuren, M.D., Director, CDRH | Comments

Just for a moment, imagine a scenario in which you have an illness that has eluded diagnosis. The usual suspects have been ruled out and no one knows exactly what’s making you sick. Using medical devices that FDA has now cleared for marketing...

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EMC Testing in Medical Device Development

November 20, 2013 12:11 pm | by Bjarne Hansen, Electrical Engineer, StarFish Medical | Comments

Medical devices containing electronics require Electromagnetic Compatibility (EMC) testing to ensure they can be used in the intended environment without failing or causing other equipment to fail. My blog Electromagnetic Compatibility (EMC)...

Transparency and Open Communication Are Key to Contract Manufacturing Relationship

November 19, 2013 2:19 pm | by Joseph Lee, President, Xeridiem | Xeridiem | Comments

Transparency and open communication are keys to good customer relationships, particularly for OEMs that have been “burned” by another contract manufacturer. Xeridiem informs the customer upfront of expected tasks, milestones, challenges...

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Standing Out from the Crowd with Your Reputation

November 18, 2013 2:10 pm | by Mike Nowaczyk, Vice President of Operations, SMC Ltd. | SMC, Ltd. | Comments

Companies stand out in this industry by providing outstanding service levels, having a good value proposition, offering low cost alternatives within and outside U.S., providing quick time-to-market solutions, having superior supply chain management...

Purple and Red: Gram Stain Test Contributes Important Information to the Sterilization Process

November 15, 2013 12:12 pm | by April Wanstrom, Microbial Identifications Study Director, Nelson Laboratories | Nelson Laboratories, Inc. | Comments

According to AAMI/ISO 11137, medical device manufacturers need to know the “number and types of microorganisms” found on their devices before sterilization. The bioburden test provides the number of microorganisms, and the Gram stain test...

Personalized Medicine: The Future Is Now

November 14, 2013 3:47 pm | by Margaret A. Hamburg, M.D., Commissioner, FDA | Comments

The difference between science and science fiction is a line that seems ever harder to distinguish, thanks in part to a host of astonishing advances in medical science that are helping to create a new age of promise and possibility for patients...

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7 Tips for Painless FDA 510(k) Regulatory Submissions

November 13, 2013 3:30 pm | by Vincent Crabtree, Ph.D., Regulatory Advisor and Project Manager, StarFish Medical | Comments

FDA Regulatory Clearance using the 510(k) Pre-market Notification process can be a painful experience to unprepared companies. My focus at StarFish Medical is regulatory compliance. I believe it is important to consider Regulatory all the way...

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Healthcare Reform Driving Out Cost at All Levels

November 12, 2013 3:24 pm | by Tim Taylor, Director of Sales-Medical, XP Power | Xp Power | Comments

The reform of healthcare provision and the way it is funded has become a very emotive issue. Whatever your thoughts and viewpoints on the topic of the Affordable Care Act, one of the underlying priorities of this reform is to drive cost out...

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Getting the Most Out of Your Contract Manufacturer Relationship

November 1, 2013 3:41 pm | by Brian Higgins, VP of Sales and Marketing, Sil-Pro | Sil-Pro, LLC | Comments

Most OEMs have much higher overhead costs due to facility occupancy rates. Their variable costs can also be higher; trying to forecast volumes and balance the level of staffing required to meet demand. There are also contingency advantages...

Price Wins the Day for Today’s Contract Manufacturer

November 1, 2013 3:30 pm | by Steve Heckman, Senior R&D Engineer, Plastics One | Plastics One, Inc. | Comments

Despite the talk of partnerships, most customers are mostly interested in low prices. In recent years, long-standing relationships have been broken by young, aggressive purchasing managers seeking to make a name for themselves by squeezing...

Trust in Manufacturing Has to be Earned

November 1, 2013 2:52 pm | by Treasa Springett, President, Donatelle | Donatelle Plastics Inc. | Comments

Trust is something that can only come over time, through building a relationship. Initially, it begins with the basics of understanding and meeting the needs of the OEM and providing strong customer service. Ultimately, it becomes a commitment...

A Good Contract Manufacturer Is a Partner

November 1, 2013 2:44 pm | by Faina Zaslavsky, Director of Microelectronics Solutions, Crane Electronics | Crane Aerospace & Electronics | Comments

Some OEMs may see the contract manufacturer as a simple service-for-fee vendor. In reality, a good contract manufacturer is a partner who co-develops the assembly with the OEM and works closely with the OEM to create a qualification and...

Innovation Today Isn’t Only About Building a Better Product

November 1, 2013 2:35 pm | by Kevin Walsh, VP and GM, Celestica HealthTech and Automated Manufacturing Services | Celestica, Inc. | Comments

For medical device companies, innovation no longer means simply creating a better product than your competitors. It’s about building a comprehensive business model that covers every aspect of a product’s life cycle. That means being innovative in...

Bright Future Ahead for Medical Molding

November 1, 2013 12:25 pm | by Stephen Lee, Business Development Manager, Pelham Plastics Corp. | Comments

We see no sign of medical molding slowing down. If fact, we see the increasing need and benefit for more comprehensive collaboration with our customers. Demand for greater product performance, such as burst pressure in a catheter device, with...

Overmolding Increased Benefits onto Medical Devices

October 31, 2013 4:39 pm | by Lee Fox, Regulatory Compliance Manager; Randy Pell, Senior Staff Design Engineer; Michael Hansen, Ph.D., Senior Technical Development Engineer; and Joan Magrath, VP, Sales & Engineering | Mackmedical/Mack Molding | Comments

Surgeons are becoming increasingly enamored with soft-touch handles on surgical instruments, which improve grip and minimize slipperiness. Handles can be overmolded in an ergonomic shape that fits the surgeon’s hand, but can still interact...

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