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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...

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...

Uninsulated Single Contact Connectors Save on Costs

November 6, 2014 7:30 am | by Tom Anderson, Connector Product Manager, AVX | Blogs | Comments

When specifying connectors for new medical devices, consider uninsulated single contact...

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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...

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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...

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...

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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 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 | 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...

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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...

Ask the Right Questions at the Right Time

September 17, 2014 8:30 am | by Bill Betten, VP Business Solutions, Medical/Life Sciences, Logic PD | Logic PD, Inc. | Blogs | Comments

I’m going to focus on the initial early stages of the idea generation and concept development. A key aspect of any idea is to understand the problem that is trying to be solved. Is there a real issue that is being addressed or is it a solution...

The Productization Plan

September 16, 2014 8:30 am | by Dana Demeo, Chief Technical Officer, Intelligent Product Solutions | Intelligent Product Solutions | Blogs | Comments

Successfully bringing an idea from concept to completion requires coordination, planning, and vision even before you get to square one; we call this the Productization Plan. More often than not, if you were to look back at ideas that seemed...

Don't Patent Too Soon: Look at the Market

September 15, 2014 8:30 am | by Stephen Knowles, Managing Director, Industrial Design Consultancy (IDC) | Blogs | Comments

The first step in new product development is to qualify the market for the idea, before doing anything else. Potential developers need to ask the questions: Does the device solve a clinical need? How will it enhance outcomes and save...

Strategize for Regulatory and Market Approval

September 12, 2014 8:30 am | by Brian Weller, VP of Quality/Regulatory Affairs, D&K Engineering | D&K Engineering | Blogs | Comments

Clearly define your value proposition. The first critical step in a serious development effort is to show a compelling need in the marketplace for your device. It may seem obvious, but history shows that often the biggest barrier to overcome...

For a Better Mousetrap, Look to the Mice

September 11, 2014 8:30 am | by Amy Munice, President, ALM Communications | Blogs | Comments

First step? Backtrack! I’ve seen many engineering-based companies sink considerable time and R&D into products that that they think are nifty and neat. The problem is that the market might not agree. Before you invest significant R&D...

Plan and Assess

September 10, 2014 8:30 am | by Aidan Petrie, Chief Innovation Officer, Ximedica | Ximedica | Blogs | Comments

Sit down and take a deep breath. Most ideas for medical devices that we see are driven by a technological breakthrough or a clinical need, but, increasingly, the driver for successful new entries is their ability to deliver a clear economic...

Reducing Risk in New Medical Equipment Development

September 9, 2014 8:30 am | by Robert Kim, Strategic Marketing Director, Honeywell Sensing and Control | Honeywell Sensing And Control | Blogs | Comments

The idea is the start, but there is a lot of work ahead to make that idea a reality. One key to success is to leverage the expertise of others as much as possible and thereby reduce risk. When equipment requires the use of sensors, far too...

Component Manufacturers in the Design Process from the Start

September 8, 2014 8:30 am | by Steven Twork, Global Market Manager, Medical Device, Bal Seal Engineering Inc. | Bal Seal Engineering, Inc. | Blogs | Comments

So many elements must be in place — the right team, funding, a distribution strategy, a regulatory strategy, and much more — but it is equally important to identify the underlying technologies necessary for design and development and to...

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