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Posted by John Lehmann on Wed, Mar 04, 2015

3 Costly Traps on the Road to Device Innovation

No matter the therapeutic area, device companies agree: Creating cutting-edge products is expensive. From the R&D costs to the pricy FDA fees, the expense for innovation adds up quickly. As products become more technologically advanced, the cost for designing new devices has increased. At the same time, device companies are being hit with fees that are wiping out their R&D budgets, such as the 2.3% medical device tax, which reportedly requires companies to collectively pay an estimated $194 million per month.

Topics: Medical Devices, Innovation, FDA Fees, MD+DI

Posted by John Lehmann on Wed, Mar 04, 2015

Will Outcomes Research Make or Break Device Companies?

Outcomes research can be defined as “the study of the end results of health services that takes patients' experiences, preferences, and values into account—is intended to provide scientific evidence relating to decisions made by all who participate in health care.” Recently, the push has been for greater emphasis on outcomes and a new joint effort is a giant boost in this direction.

Topics: Medical Devices, Outcomes Research, SharedClarity, MD+DI

Posted by John Lehmann on Mon, Jul 09, 2018

New EU Medical Device Regulations Expected

In an article written by Jamie Hartford and published in MDDI, indicates that new EU medical regulations are expected to be finalized this year or next.  In an earlier blog, we wrote on the pending regulations and the impact it might have on the medical device industry.

Topics: European Union, PIP Scandal, Regulations, MD+DI

Posted by John Lehmann on Wed, Mar 04, 2015

Obstacles for Bionic Medical Devices

Chances are you may have seen an amputee or person with a disability with a sophisticated and complex medical device before.  What you probably didn’t stop to consider is where they got it and who created it?   Bionic medical devices are devices that have an electrical component which allows them to sense muscle contractions in the human body, then send electrical signals to nerves allowing a response.  Since bionic medical devices are devices by definition, they must also seek a pathway to FDA approval before they can be marketed in the U.S.  Given the small population of individuals, relatively speaking, who need these devices the most common pathway to approval is through a Humanitarian Device Exemption (HDE).  Like any pathway to marketing approval (510(k), Investigational Device Exemption, Investigational New Drug) there is a consider amount of research and development, and capital needed to achieve it.  Jamie Hartford, the managing editor of Medical Device and Diagnostic Industry (MD+DI) News Products and Suppliers recently published an online article outlining some of the common obstacles faced when working to achieve approval for these bionic medical devices.

Topics: MD+DI, Humanitarian Device Exemption, Bionic Medical Devices

Posted by Jacqui Lingler on Wed, Mar 04, 2015

5 BIG Challenges Concerning Combination Products

The area of combination products is an exciting expanse of potential innovation and discovery for both the medical device and drug industries. However, there are many unique aspects that must be considered when dealing with combination products.

Topics: Office of Combination Products, Combination Products, MD+DI

Posted by Brandy Chittester on Wed, Mar 04, 2015

Will Outcomes Research Make or Break Device Companies?

Outcomes research can be defined as “the study of the end results of health services that takes patients' experiences, preferences, and values into account—is intended to provide scientific evidence relating to decisions made by all who participate in health care.” Recently, the push has been for greater emphasis on outcomes and a new joint effort is a giant boost in this direction.

Topics: Outcomes Research, SharedClarity, Medical Device Companies, MD+DI

Posted by John Lehmann on Wed, Mar 04, 2015

Will the Medical Device Industry be Forced to Consolidate?

A headline recently caught our attention, “What Will the Device Industry Look Like in Two Years or Less?” The article was posted on MD+DI and sheds light on what the industry may look like in 2015 after taking into account historical patterns, analyst view points, and current trends across the device world.

Topics: Consolidate, Glenn Novarro, Medical Device Industry, MD+DI

Posted by John Lehmann on Mon, Nov 06, 2017

Medtech Views Outsourcing as a Necessity

Recently released by MD+DI and ITG Market Research, the "Medical Device Outsourcing Landscape Study" found that 41% of the 853 medical device professionals that responded expect their companies will “increase use of contract services” over the next five years. Another MD+DI article referenced that many believe the industry is headed for change and uncertainty.  Medical device companies are facing increasing pressure in cost, time to market, and a tougher regulatory environment.

Topics: Outsourcing, Medtech Industry, ITG Market Research, MD+DI

Posted by John Lehmann on Wed, Mar 04, 2015

Is the Medical Device Review Process Improving?

For quite some time we’ve watched the blame for slow review times pass between industry and FDA. One side claims the pathway to approval lacks transparency and predictability, the other claims the submissions are of poor quality. But could this coming year be the start of a new relationship between FDA and industry?

Topics: Medical Device Review Process, FDA, CDRH, MD+DI

Posted by John Lehmann on Fri, Jun 03, 2016

Running a Clinical Trial Outside the US? Be Prepared.

Half the battle when facing obstacles or challenges is proper preparation. Knowing what types of challenges you may face is one way to ensure you have a well-thought out plan for the situation. So much opportunity exists around the world and as of late it has been an industry trend to operate studies outside the US.

Topics: Overseas Clinical Trials, Clinical Research, MD+DI

Posted by John Lehmann on Wed, Mar 04, 2015

Do You Need a Regulatory Strategy-- or Plan?

An article in MD+DI dissects the difference between a regulatory strategy and a regulatory plan by simply asking five questions to regulatory affairs expert, Michael Santalucia. We found this article to be very interesting, considering many may not have examined these differences before, which may lead to better regulatory understanding and success. The five questions, and summarized comments from the article, are listed below:

Topics: Regulatory Strategy, Michael Santalucia, FDA, MD+DI

Posted by John Lehmann on Wed, Mar 04, 2015

Friday Fun: Nick-names for Medical Devices

A recent DeviceTalk blog on MD+DI caught my attention. The article’s title, “What’s in a Medical Device’s Name? For Patients, a Lot” speaks to the fact that for some patients a lifetime is spent with their medical device. This is especially true for those with chronic conditions, like Type I diabetes.

Topics: Medical Devices, medical device patients, MD+DI

Posted by John Lehmann on Wed, Mar 04, 2015

A Call for Change at the FDA

The drumbeat for change at the FDA continues.  According to an article in MD+DI, leaders of Minnesota companies and venture capitalists believe the industry faces a dire future unless the FDA changes its policies and procedures.

Topics: A Call for Change, Medtech Industry, FDA, MD+DI

Posted by John Lehmann on Wed, Mar 04, 2015

What Threatens the Medical Device Industry?

Recently MD+DI published an article, “The U.S. Medical Device Industry in 2012: Challenges at Home and Abroad.” The article speaks to the Industry being a source of jobs, innovation and revenue for Americans. In addition, U.S. has been the longtime world leader for the medical device industry.

Topics: Threats to Medical Device Industry, FDA, Medical Device Industry, MD+DI

Posted by John Lehmann on Wed, Mar 04, 2015

What Exactly Are Device-Drug Combination Products?

The area of combination products is an exciting expanse of potential innovation and discovery for both the medical device and drug industries. But what exactly are combination products? According to 21 CFR 3.2(e), they are defined as:

Topics: Office of Combination Products, Combination Products, FDA, MD+DI

Posted by John Lehmann on Fri, Jun 03, 2016

Will 2.3% Sales Tax Push Med-tech Companies Overseas?

There has been much talk recently about the proposed changes to the regulatory and healthcare systems in the U.S. for the medical device industry. A recent MD+DI article by Nick Woods, director of Woods Medical Media, describes these proposed changes and how they might impact our industry. Woods points out that while President Obama’s PPACA document contains 2074 pages filled with words, for most, one number holds the most weight. The 2.3% sales tax on medical devices expected to come into effect a year from now. The industry seems to be united against this new tax. Our blog last October highlighted Senator Scott Brown’s plight for a repeal, and there have been numerous other calls to have it eliminated.

Topics: Medical Devices, technology solutions, nick woods, MD+DI

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