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Reassessing Risk in the Design Process

March 11, 2014 3:09 pm | by Brian Gough, Projects Director, IDC | Blogs | Comments

The recent change in ISO 14971:2012 Application of risk management to medical devices, requires a change to the way risk is assessed during the design process. Where user risk was once mitigated by the Instructions for Use (IFU), the IFU...

Know Your Material Debris for Implantables

February 7, 2014 12:42 pm | by Elaine F. Schumacher, Senior Research Scientist, McCrone Associates Inc. | Blogs | Comments

McCrone Associates is a consulting laboratory with extensive experience in materials analysis,...

New Developments in 2014 Bring Challenges for Designers

January 31, 2014 1:53 pm | by Mike Brousseasu, Manager — Safety Group, and Joe Langton, Business Service Line Leader — Chemical, Intertek | Blogs | Comments

In the coming year, medical device manufacturers will need to focus on getting their products...

Thermal Management Solutions for MedTech

January 27, 2014 12:21 pm | by Matt Connors, Engineering Group Leader, Thermacore, Inc. | Blogs | Comments

Regardless of whether the 2.3% medical device tax is here to stay or not in 2014, regulatory and...

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Securing Patient Information Is the Top Priority

January 22, 2014 12:46 pm | by Steve Spatig, General Manager, Electronic Access Solutions, Southco | Southco | Blogs | Comments

With HIPAA audits scheduled to begin in 2014, many healthcare providers are concentrating their efforts on their approach to how patient information is secured. With audits focusing on breach notification, it is essential that healthcare...

Looking Ahead at Imaging Technology

January 20, 2014 1:52 pm | by Adrian Wilson, Head of Technologies, Element Six | Blogs | Comments

Today’s magnetic resonance imaging (MRI) technologies, aiding the measurement of illness diagnose and treatment, even when stretched to their limits, have not allowed for resolution beyond a few micrometers and traditionally require expensive...

MedTech Strategic Convergence Set for 2014

January 17, 2014 12:28 pm | by Deb Kacera, Regulatory & Industry Strategist, Pilgrim Software Inc. | Pilgrim Software, Inc. | Blogs | Comments

In 2014, we will see the next evolution of the most effective utilization of resources across the medical device industry, based on “smart” information that will touch almost every healthcare stakeholder, where key data will have a tighter...

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Direct Part Marking for UDI Needs

January 16, 2014 3:01 pm | by Gerry Gunderson, CPP, VP of Engineering, Quality Tech Services | Quality Tech Services, Inc. | Blogs | Comments

The Final Rule for FDA’s Unique Device Identification (UDI) mandate is now released and will be in focus in 2014. Class III device manufacturers will need to comply by September 2014, unless granted an exception (and excluding grandfathered...

Developing Medical Devices at a ‘Sprint’ Pace

January 15, 2014 2:04 pm | by Eric Sugalski, Founder and CEO, Boston Device Development | Boston Device Development | Blogs | Comments

In 2014, the medical device industry will see increasing interest in “agile development,” a process of iteration that has become a mainstay in software development. Rather than following the standard waterfall process, teams will rely on...

Newly Insured Bring New Opportunities and Challenges

December 19, 2013 4:12 pm | by Michael Frank, Healthcare Industry Expert, PA Consulting Group | Blogs | Comments

The medical device sector has emerged from the winter of the great recession into a much more price sensitive market. Pressure is mounting to reduce cost of devices where there are cheaper alternatives. While the 2.3% medical device excise...

Wireless, Disposable Sensors for Patient Monitoring on the Way

December 18, 2013 4:11 pm | by Jonathan Sbert, Product Line Manager for Healthtech, Texas Instruments | Texas Instruments Inc. | Blogs | Comments

Technology that enables wireless and disposable human diagnostic sensors for ECG, pulse oximetry, heart monitoring, temperature, and other measurements will be prevalent in 2014. Imagine the day when a patient lies in a hospital bed completely...

Reducing Costs by Extending Product Life

December 17, 2013 2:25 pm | by Tim Taylor, Director of Sales, Medical, XP Power | Xp Power | Blogs | Comments

As a manufacturer of medical grade power supplies, we see many changes in the coming year. The U.S. healthcare industry is going through a transformation that will have a different landscape. The medical device manufacturers that are leading...

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A MedTech Accelerator Model

December 16, 2013 3:13 pm | by Laura Faulconer, Business Development Manager, STC | Blogs | Comments

With the dramatic growth of the IT sector over the last decade, novel commercialization models like the start-up accelerator have emerged. A typical IT accelerator provides a small investment (usually $10,000 to $50,000) alongside rigorous...

Test Equipment Critical for Successful Kidney Dialysis Devices

October 16, 2013 4:47 pm | by Gene Grilli, Director of Global Sales, Uson | Uson, L.P. | Blogs | Comments

Most people know that a major function of the kidneys is to remove waste products and excess fluid from the body. These waste products and excess fluid are removed through the urine. When the kidneys become damaged or diseased, it becomes...

Antimicrobial Materials Can Aid with Patient Safety

October 16, 2013 4:39 pm | by Lawrence Gabriel, Business Development Manager, Molding Compounds/Performance Polymers, Evonik Corporation | Evonik Cyro, LLC | Blogs | Comments

As a leading supplier of acrylic-based thermoplastic products, Evonik Cyro is continually working with its end-users on the identification of current and future product needs. Citing the demand for products that have antimicrobial capabilities...

Enhancing Safety with Human Factors Design

October 16, 2013 4:34 pm | by Zach Marks, Director of Strategic Marketing, Pharmaceutical Delivery Systems, West Pharmaceutical Services | West Pharmaceutical Services, Inc. | Blogs | Comments

Human factors design and testing, combined with improved instructions for use, can greatly enhance patient compliance and health outcomes. Many well-intentioned devices are underutilized because the patient cannot understand the proper way...

Driving Patient Safety Throughout the Development Process

October 16, 2013 4:02 pm | by Jonathan Martha, Medical Segment Manager, Portescap | Portescap | Blogs | Comments

At Portescap, we supply motors and gearing that go into critical care home medical devices. To ensure patient safety, we use prevention, containment, and OEM feedback. During product design, we use a stage-gate system that incorporates multiple...

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Compliance Conscious Suppliers Enhance Patient Safety

October 9, 2013 5:10 pm | by Seth Stewart, PASE System Designer, Watlow | Watlow Electric Manufacturing Company | Blogs | Comments

As a strategic supplier to medical OEMs, it is vital that Watlow remains knowledgeable of changes in market needs and regulations. This allows us to design and develop products in a rapid fashion that meet the unique requirements of the medical equipment market.

Is Tape Encryption the Answer for Data Security?

September 27, 2013 4:22 pm | by Laura Loredo, Product Marketing Manager, Nearline Storage, Hewlett Packard; Craig Butler, Senior Program Manager, Data Protection and Retention Systems, IBM; and Yan Yan Liang, Segment Marketing Manager, Quantum Corporation | Blogs | Comments

Medical professionals can agree that protecting patient information is one of their top priorities. Patients put a lot of trust into their healthcare providers to maintain that their information is never lost or stolen, and providers are subject to rigorous standards, such as the Health Insurance Portability and Accountability Act (HIPAA).

Device Makers: Custodians of Patient Data

September 25, 2013 3:04 pm | by Charles Murphy, Vice President, Cloud Operations, Pilgrim Software | Pilgrim Software, Inc. | Blogs | Comments

The key to protecting PHI data is education, execution, and continuous verification. The first thing is to understand your obligation as a custodian of this sensitive data. This is best done through formal HIPAA/HIPAA-HITECH training to understand the regulation.

Determining Marginal Improvement in Innovation

September 25, 2013 10:23 am | by Keith Calvert, Director, CMNA Engineering Administration, The Tech Group | The Tech Group, Inc. | Blogs | Comments

Research and development is the cornerstone of growth in the medical device industry. R&D funding is available; however, the issue isn’t availability as much as availability for marginal improvement. The question to ask is, “Will a marginal improvement reduce costs for the patient and caregiver?”

Innovation Will Come via Investment

September 20, 2013 1:59 pm | by James H. Bleck, President/CEO, Bleck Design Group | Bleck Design Group | Blogs | Comments

We see funding for new medical devices driven by private investment from individuals or private companies. These bold investors are capable of quick decisions as they meter the funding to match progress and discover the real market opportunity.  

Partnerships Can Keep Medical Innovation Alive

September 18, 2013 12:21 pm | by Greg Thompson, VP of Engineering, Sanmina Medical Division | Blogs | Comments

The financial pressures medical device OEMs are facing are very real. They’re experiencing reduced reimbursements from the government and insurance companies, increased taxes, and global competition. As a result, new business models are evolving to ensure new product innovation is not stifled and, most importantly, patient safety is not compromised.

Innovation Impacted for Start-Ups

September 17, 2013 4:02 pm | by Randolph J Sablich, President and CEO, Metrigraphics, LLC | Metrigraphics, LLC | Blogs | Comments

While Metrigraphics LLC certainly does not speak for the medical device OEM industry, as a custom contract manufacturer of leading edge micro components, we certainly feel the impacts of various external elements on the ebb and flow of R&D and innovation activities of the OEMs.

Addressing Financial Pressures in Device Development

September 16, 2013 3:10 pm | by James Schultz, Research and Development Engineer, Plastics One | Plastics One, Inc. | Blogs | Comments

As OEM’s streamline to meet financial pressures, top level designs will be emphasized but second and third level particulars will adhere more closely to a suppliers understanding of their present capability. The particulars are under a fine balancing act and vision outside will require a thorough knowledge, down to the step-by-step production process to lean out waste.

Packaging Provides Initial Dataset Necessary for Patient Confidentiality

August 28, 2013 3:49 pm | by Tom Egan, Vice President, Industry Services, PMMI | Blogs | Comments

Making sure patient information is secure begins with coding on the package. No matter to whom the medical device is targeted—for a specific patient, hospital, or doctor—the coding placed on the package is the first part of the data set used to track the device.

Security for EHRs

August 28, 2013 3:32 pm | by Steve Spatig, General Manager, Electronic Access Solutions, Southco | Southco | Blogs | Comments

While the adoption of electronic health records helps healthcare facilities streamline data collection and retention, it also presents challenges when it comes to security. Traditional paper file storage in healthcare facilities is being replaced by computers and portable electronic devices that are often more exposed to threats.

Your Data Is Only as Secure as Your Device

August 28, 2013 3:24 pm | by Alan Grau, CEO, Icon Labs | Blogs | Comments

The inherent insecurity of many medical devices was highlighted in a recent FDA and Homeland Security alert. Over 300 devices have been identified that utilize a hard code password, creating a huge security loophole. With so many medical devices now collecting and storing patient data, this raises the question of how secure is the data stored on these devices?

Material Suppliers Assist in Fight Against HAIs

August 12, 2013 4:02 pm | by Kathy S. Tucker, North America Application Development Leader, Styron LLC | Blogs | Comments

When it comes to HAIs, material suppliers are assisting device makers in a several ways. First, we’re developing materials with properties to withstand the aggressive cleaners needed to reduce bacteria and fight the spread of infectious diseases. 

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