Advertisement
Blogs
Subscribe to MDT Magazine Blogs

From Concept to Company: 5 Steps in the Journey of a Medical Device Startup

November 10, 2014 7:30 am | by Nate Rhodes, Chief Executive Officer, Veritas Medical LLC | Comments

Innovation is the life force of the medical device industry. Without a large budget for in-house R&D, licensing or acquiring a new technology, many companies are losing market share to those with deep pockets. To avoid the bureaucracy of...

TOPICS:

Examining the Physician Office Lab Market: Japan and Global Overview

November 7, 2014 3:07 pm | by Richard Park, Contributing Editor | Comments

Japan’s highly centralized healthcare system has not left much room for physician office testing, outside of a sizeable physician office laboratory (POL) flu testing market. Epidemic and pandemic influenza strains in Asia significantly increased the need...

TOPICS:

Don't Skip the Necessary Steps

November 7, 2014 7:30 am | by Don Biszek, Director of Program Management, Stratos | 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...

TOPICS:
Advertisement

Will ‘Outsiders’ Overtake the Medical Device Industry?

November 6, 2014 4:37 pm | by Sean Fenske, Editor-in-Chief | Comments

The real variable that makes companies like Google and Apple a threat to the more established medical device players (well, besides a big bankroll) is the experience and mindset they have. These are consumer companies who have been extremely...

TOPICS:

Uninsulated Single Contact Connectors Save on Costs

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

TOPICS:

Sudden Impact – The Wearable Design Challenge

November 5, 2014 9:25 am | by Christian DeFeo, eSupplier and Innovation Manager, Newark element14 | Comments

The wearable health market is at a turning point. An IHS report estimates more than 250 million related devices will ship over the next five years alone. For engineering firms and technology companies, the time is now to not only participate in this...

TOPICS:

5 Indicators the Medical Device Industry Is Hitting Its Midlife Crisis

November 5, 2014 8:09 am | by Dave Powell, Partner A.T. Kearney | Comments

The medical device industry, which has enjoyed the enviable position of gaining five percent average annual growth and operating margins between 23 and 25 percent, is next in line to get turned on its head by industry disruptors. The future of...

TOPICS:

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 | 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...

TOPICS:
Advertisement

Be Thankful Marketing Isn't Running the R&D Lab

November 4, 2014 3:53 pm | by Sean Fenske, Editor-in-Chief | Comments

In such a highly regulated marketplace that so strongly depends on relationships, is your absence at an industry trade event going to significantly impact the perception your customers or manufacturing partners have? If it does, perhaps you haven’t…

TOPICS:

Developing Devices for Disabled Patients with FDA Encouragement

November 4, 2014 2:15 pm | by William Maisel, M.D., M.P.H., Deputy Center Director for Science, FDA, and Chief Scientist CDRH | Comments

For people with disabilities, medical devices can offer a vital and potentially life-changing option. Take, for example, a patient who has had his arms amputated. Medications can treat phantom pain, but they can’t help that patient pick up a glass...

TOPICS:

Have a Clear Cost Benefit

November 4, 2014 8:30 am | by Eric Sugalski, Founder, Boston Device Development | Boston Device Development | 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...

TOPICS:

Congress Tackles LDT Regulation: The Roles of FDA v. CMS

November 3, 2014 2:03 pm | by Richard Park, Contributing Editor | Comments

FDA recently released its two draft guidances on the regulation of laboratory-developed tests (LDT): Framework for Regulatory Oversight of LDTs and FDA Notification and Medical Device Reporting for LDTs. With the release of these guidances...

TOPICS:

Integrate Validated Off-the-Shelf Components

November 3, 2014 8:30 am | by Jim Ford, Manager of Corporate Product Management, Southco, Inc. | 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...

TOPICS:

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 | 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...

TOPICS:

Establish Communication Up Front

October 30, 2014 8:30 am | by Dave Beckstoffer, Commercial Program Manager, Portescap | Portescap | 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...

TOPICS:

Pages

X
You may login with either your assigned username or your e-mail address.
The password field is case sensitive.
Loading