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Trust, But Verify In Order to Comply with UDI

December 5, 2014 7:30 am | by Steve Cochran, Chief Technology Officer, GHX | 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...

Develop an Internal Team for UDI

December 4, 2014 7:30 am | by Deborah Kacera, Regulatory & Industry Strategist, Pilgrim Quality Solutions | 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 | by Matt Kelly, Key Account Manager, Medical, Watlow | 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...

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Have A Solid Team in Place for UDI Compliance

December 2, 2014 7:30 am | by Linda Chatwin, Esq, RAC Manager, Medical Regulatory Advisory Services North America, Life and Health, UL LLC | 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 | by Deborah Kacera, Regulatory & Industry Strategist, Pilgrim Quality Solutions | 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 | by Richard Whipple, Marketing Communications Manager, Parker Hannifin Corporation, Precision Fluidics Division; Ben Furnish, Marketing Manager, Parker Hannifin, Electromechanical Division | 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...

Don't Skip the Necessary Steps

November 7, 2014 7:30 am | by Don Biszek, Director of Program Management, Stratos | 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 | by Tom Anderson, Connector Product Manager, AVX | 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...

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Discipline and Project Management Skills for Cutting Costs

November 5, 2014 7:30 am | by Brian Weller, VP of Quality/Regulatory Affairs, D&K Engineering | 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 | by Eric Sugalski, Founder, Boston Device Development | 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 | by Jim Ford, Manager of Corporate Product Management, Southco, Inc. | 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...

Don't Do It Quickly, Do It Right

October 31, 2014 8:30 am | by Jim Janicki, Executive Vice President of Engineering & Quality, RTEmd | 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 | by Dave Beckstoffer, Commercial Program Manager, Portescap | 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...

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Cold Deck to Reduce Volume of Material

October 29, 2014 8:30 am | by Jim Ritzema, Director of Operations, Rogan Corporation | 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 | by David Morse, General Manager, Tube Hollows International | 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 | by Robert Kim, Strategic Marketing Director, Honeywell Sensing and Control | 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 | by Scott Levy, Senior Packaging Editor, DDL Inc. | 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 | by Anthony Kalaijakis, Strategic Medical Marketing Manager, Molex | 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 | by Walter Zic, Chief Operating Officer, EDM Department Inc. | 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 | by Chris Zandstra, Engineering Manager, Rose Technologies | Rose Medical | 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 | by Brian Handerhan, Business Development Manager, Parker Hannifin | 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 | by Joey Benadretti, President, SYSPRO USA | 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 | by Mark Shal, Ph. D., Founder, Insight Technology | 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...

Test with a Prototype

September 19, 2014 8:30 am | by Anthony Appling, Senior Director of Research & Development, MedVenture Technology, A Helix Medical Company | Blogs | Comments

There are a few crucial steps that should be taken before significant investment is made or development efforts are put forth. First of all, one should develop a problem statement. You need to determine what specific problem is being addressed...

Don't Go It Alone

September 18, 2014 8:30 am | by David Perry, Engineer, Boston Device Department | Blogs | Comments

Focus your efforts on identifying the key assumptions or biggest lingering questions around your new medical device, then build something small and focused to test them. Intuition and math can tell you something should work, but you don't...

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