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Automating the Manufacturing Process in 2015

January 29, 2015 9:00 am | Beahm Designs, Inc. | Blogs | Comments

As the medical device industry continues to face complex challenges in new product development and launch, the trend in 2015 will increasingly migrate toward automation at every level of the medical device manufacturing supply chain. When we...

Speeding Up Diagnosis and Embracing Telehealth in 2015

January 29, 2015 8:30 am | Blogs | Comments

Technology implemented well is greatly increasing our ability to understand the human body...

2015 Will Require Implementation of Thorough Security Programs

January 28, 2015 8:30 am | Blogs | Comments

In April of 2014, Wired Magazine made the rattling...

Next-Gen Home-Use Products Require Small, High-Performing Sensors

January 27, 2015 8:47 am | Blogs | Comments

Medical equipment, driven by patient convenience and cost reduction, is moving from the...

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Finding Some "Sense" in 2015

January 27, 2015 8:30 am | Blogs | Comments

During 2015, sensors will continue to be a driving force for innovative medical devices. We will see advances in chemical sensors, especially "lab on a chip," and paper-based sensors. Driven by faster analysis time and extremely small fluid...

Exploit Opportunities Offered by UDI Initiative

December 8, 2014 7:30 am | Blogs | Comments

Sep. 24 saw the first UDI compliance deadline which means that organizations should now be focusing on the implementation phase, following a thorough preparation phase reviewing all current processes and systems in place. The implementation...

Trust, But Verify In Order to Comply with UDI

December 5, 2014 7:30 am | Blogs | Comments

“Trust, but verify” is my advice to manufacturers seeking to comply with the UDI rule. As a third party submitter that has successfully loaded data into the Global UDI Database (GUDID), I can confidently tell manufacturers, "trust that it...

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Develop an Internal Team for UDI

December 4, 2014 7:30 am | Blogs | Comments

Working with industry, we still see a need for more internal conversations among various stakeholders within organizations for an effective rollout of UDI. This is because the regulation has “amended” many existing regulations that will impact...

Roll-Out UDI to the Device Manufacturer and Supply-Chain Partners

December 3, 2014 7:30 am | Blogs | Comments

The Food and Drug Administration (FDA) has released a final rule requiring that most medical devices distributed in the United States carry a unique device identifier, or UDI. A UDI system has the potential to improve the quality of...

Have A Solid Team in Place for UDI Compliance

December 2, 2014 7:30 am | Blogs | Comments

Preparing for UDI requires a well-thought through project plan. Someone in the organization needs to own the project and manage it carefully, or bring in outside resources to help. The key to success lies in examining current labeling processes...

Search History for 'Lessons Learned'

November 18, 2014 7:30 am | Pilgrim Quality Solutions | Blogs | Comments

Increased quality and regulatory oversight, increased demand from an aging population and reduced reimbursements are realities for medical device companies. The Medical Device industry will have to focus on reducing costs in the product...

3 Factors to Consider When Cutting Development Costs

November 17, 2014 9:26 am | Blogs | Comments

It’s hard for a single company to do everything well; every company has its core competencies. So partnering with the right vendor in ways that supplement a medical device manufacturer’s core competencies is a key strategy many OEMs use to cut...

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Don't Skip the Necessary Steps

November 7, 2014 7:30 am | Blogs | Comments

In the fast-paced world of medical technology, a lot of the ideas companies have to cut costs end up costing more in the long run. Product development firms are moving more work overseas for cheaper rates. While that works for some aspects...

Uninsulated Single Contact Connectors Save on Costs

November 6, 2014 7:30 am | AVX | Blogs | Comments

When specifying connectors for new medical devices, consider uninsulated single contact solutions. These UL-certified contacts match the performance, robustness, and reliability of full connector solutions without the additional component and...

Discipline and Project Management Skills for Cutting Costs

November 5, 2014 7:30 am | D&K Engineering | Blogs | Comments

For those of us who've had the experience of looking back on a development project that ran late and over budget, we probably had to endure some Monday morning quarterbacking about "doing it right the first time". Easier said than done. But...

Have a Clear Cost Benefit

November 4, 2014 8:30 am | Boston Device Development | Blogs | Comments

The new reality of medical devices is that improved outcomes can no longer justify increased healthcare costs. In the changing healthcare landscape, new medical devices must offer a cost benefit, meaning that the economic value derived from adoption...

Integrate Validated Off-the-Shelf Components

November 3, 2014 8:30 am | Blogs | Comments

In a rapidly consolidating medical device market, the need to quickly release cost effective designs is greater than ever. When considering design options, keeping a focus on the total cost of each design option is essential. Choices between...

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Don't Do It Quickly, Do It Right

October 31, 2014 8:30 am | RTEmd | Blogs | Comments

Regulatory requirements, business pressures (to get products to market faster), and cost implications often cause good teams to take short cuts. Even highly compliant organizations, when rushed, can lose discipline, causing developers to stray...

Establish Communication Up Front

October 30, 2014 8:30 am | Portescap | Blogs | Comments

For the motion control of any medical device, cost pressures always exist to keep them as low as feasible while still providing the performance required. The key is early engagement with the motion control manufacturer to ensure the development...

Cold Deck to Reduce Volume of Material

October 29, 2014 8:30 am | Blogs | Comments

To reduce costs and increase productivity, we have added a cold deck to our vertical liquid silicone rubber (LSR) molding machine. The cold deck reduces the volume of LSR material we use during molding by eliminating the sprue and runner...

Savings Comes from Unexpected Places

October 28, 2014 8:30 am | Blogs | Comments

Cost savings often come from unexpected places. Two examples that come to mind involved the design and processes used to achieve high precision holes in cannulated parts. Tube Hollows International can drill extremely precise holes (as low...

Decide Where and How it is Best to Reduce Costs

October 27, 2014 8:30 am | Honeywell Sensing And Control | Blogs | Comments

In today’s medical equipment market, one path towards increased competitiveness is to reduce component costs. However, OEMs must be thoughtful and think holistically about where and how to cut costs. For example, sensors are often critical...

Don't Leave It Until the Last Minute

October 24, 2014 8:30 am | Blogs | Comments

The “Just-in-Time” mentality that has become more pervasive within the medical device industry has also resulted in many more package validation testing projects being rushed and left to the last minute. This situation can pose a significant...

Make Cooperative Decisions and Provide Incentives

October 23, 2014 8:30 am | Molex | Blogs | Comments

Healthcare reforms are driving Medtech companies to re-evaluate how they go to market and, at the same time, protect their heavy investment in current architecture. In the regulated Medtech industry, manufacturers must ensure products are...

CLM Machine for Conservation and Maximization of Resources

October 22, 2014 8:30 am | EDM Department | Blogs | Comments

I believe the solution to cutting costs in the development of medical devices lies within the technology of CLM (closed loop manufacturing). Traditional measurement procedures can be both elaborate and error-prone as they necessitate constant...

Establish Cost Based on Time and Materials

October 21, 2014 8:30 am | Rose Technologies | Blogs | Comments

As a contract manufacturer, when we quote development projects to our customer, we prefer to use a time and materials basis instead of a flat rate. This method gives the developer the flexibility to keep the project moving when the scope...

Leverage a Quality Function Deployment Tool

October 20, 2014 8:30 am | Blogs | Comments

I personally subscribe to the concept that 80% of the cost optimization opportunity of any product is frozen at the point of the design freeze, leaving only 20% of the opportunity to be addressed through conventional cost reduction efforts...

An ERP Software Solution for Managing Costs

October 17, 2014 8:30 am | Blogs | Comments

Employ Enterprise Resource Planning (ERP) software to facilitate timely and accurate decision-making via access to real-time, integrated data. Predict demand to optimize inventory levels. Streamline supply chains to maximize efficiencies...

Simplify to Cut Costs

October 16, 2014 8:30 am | Blogs | Comments

The key word characterizing today's medical device development environment is confusion. In addition to doing their jobs, people are being asked to implement confusing, complex, and at times misleading procedures. Pushed by the FDA to move...

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