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The Lead

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 f...

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...

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...

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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...

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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...

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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...

Quality Products/Services to our Aging, Technologically Astute Population

September 5, 2014 8:30 am | by Deborah Kacera, Regulatory & Industry Strategist, Pilgrim Software | Blogs | Comments

As the world population’s average age is increasingly rising, the home health industry is continuing to grow and mobile healthcare-related technology is evolving. As a result, more digital health companies and mobile devices will emerge...

Keeping Pace: A Continuous Improvement Process

September 4, 2014 8:30 am | by Bill Betten, VP of Business Solutions, Medical/Life Sciences, Logic PD | Blogs | Comments

I believe it is important that the FDA continuously revisit their decision regarding medical device apps. As of 2013, the FDA had cleared and registered just over 100 medical apps, nowhere near the current pace of app development, which...

Higher Risk and Longer Investment Window

September 3, 2014 8:30 am | by Marc Dubreuil, Vice President of Business Development, Farm Design | Farm | Blogs | Comments

In some ways, venture capitalists and high net worth individuals are already doing this by funding syndicates that number anywhere from six to 20 investors. However, these are seasoned investors who possess a vast knowledge of the competitive...

Necessary to Understand Market Demand

September 2, 2014 8:30 am | by David Bratvold, Founder, Daily Crowdsource | Blogs | Comments

I believe crowdfunding for medical device development is not only viable, but it's an absolute necessity. However, the biggest benefit of crowdfunding is not the money you receive to develop your device, but rather a concrete understanding...

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Voting with Their Dollars

August 28, 2014 8:30 am | by Jonathon Kemnitzer, Principal, KEM STUDIO | Blogs | Comments

At KEM STUDIO, we’ve successfully funded an industrial design project, called “Skate Bench No. 1,” through Kickstarter in 2011. This skateboard-inspired bench was noticed by professional skateboarders Mike V (Vallely) and Tony Hawk who used...

Opportunities for Attraction

August 28, 2014 8:30 am | by Alex Fair, Chief Crowdologist, MedStartr.com | Blogs | Comments

I run the leading crowdfunding site for medical innovations and about a third of our clients have some sort of medical device. So far, we have helped about a dozen medical device companies get found and funded just with rewards and donations...

Solving a Customer's Problem

August 27, 2014 8:30 am | by Walter Hock, Director, Product Management, Portescap | Portescap | Blogs | Comments

In today’s rapidly changing market, clinicians and aspiring entrepreneurs with an idea for a medical device should first be very clear in understanding the problem they are solving for the customer. Often, clinicians and entrepreneurs are...

Risky Device MMAs Should Be Regulated

August 25, 2014 2:31 pm | by Steven G. Richter, Ph.D., President and Chief Scientific Officer, Microtest Laboratories Inc. | Microtest Laboratories, Inc. | Blogs | Comments

I agree that the FDA should regulate mobile medical apps (MMA) because there is a potential that certain apps used to treat and diagnosis disease states can be harmful to patients when not working properly. When the FDA published the current...

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. | McCrone Associates, Inc. | Blogs | Comments

McCrone Associates is a consulting laboratory with extensive experience in materials analysis, much of it in the area of medical device development. Growing use of joint prostheses, combined with introduction of novel materials and coatings...

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 compliant, available, and possibly re-designed to keep up with the ever-changing standards associated with the medical device industry. The Affordable...

Thermal Management Solutions for MedTech

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

Regardless of whether the 2.3% medical device tax is here to stay or not in 2014, regulatory and competitive pressures are forcing medical OEMs to consider new technologies to reduce costs. Active thermal management technologies, such as...

Securing Patient Information Is the Top Priority

January 22, 2014 12:46 pm | by Steve Spatig, General Manager, Electronic Access Solutions, 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 Quality Solutions | 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...

Direct Part Marking for UDI Needs

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

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