Mark Kramer answers 5 questions on combination products and the regulatory hurdles manufacturers can face.

Mark Kramer Regulatory Strategies Inc1. What is a combination product?

A combination product is a combination of different types of regulated products, i.e., a drug and a device, a drug and a biologic, a device and a biologic, or a combination of a drug, device and biologic. FDA recognizes 3 types of combination products, where the components are (1) physically/chemically combined into a single entity (like a drug-coated catheter), (2) packaged together, or (3) separate products brought together through their labeling (“cross labeling”). The US is unique in recognizing cross labeled components as combination products, and these sometimes raise challenging regulatory issues.

2. How does FDA...

February 3rd, 2012
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On the heels of a scientific study on faulty breast implants manufactured by French company Poly Implant Prothèse (Pip), the European Commission (EC) has called for a "series of immediate measures to strengthen the existing surveillance and safety controls on medical devices already on the market," according to Health and Consumers Commissioner John Dalli. In a press release issued on 2 February by the EC, Dalli also noted  that a "stress test of legislation on medical devices is underway in order to identify how best the questions raised by this issue can be addressed in the revision of [the medical device directives]."

For more about this study and its potential impact on the medical technology industry, see my blog post on emdt.co.uk...

February 3rd, 2012
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A letter to to the New York Times was published yesterday, from AdvaMed Spokesperson, Christopher L. White. In it, White establishes support for the Physician Payment Sunshine Act, saying it "complements our code of ethics."

The editorial comes in response to several opinion pieces published over the last few weeks, since CMS issued its draft guidance: 

  • One was from Thomas P. Stossel in the Wall Street Journal, in which Stossel concludes that patients, physicians, and manufacturers lose ground, while "accountants, compliance bureaucrats, and the legions of lawyers" rake in profits and troll the "Sunshine" database to further find evidence of wrongdoing. He also says that critics of such payments have failed to find evidence that...
February 1st, 2012
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Ralph Hugeneck

Asia has a different meaning for many medical device companies than it did just a few years ago. China in particular was once largely viewed as an inexpensive manufacturing destination for products for the Western market. But, with the ascendancy of China and India, now the continent is coming into its own as a market unto itself. “We are seeing a lot of medical device companies that are looking to serve the local market in Asia—especially the Chinese market,” says Ralph Hugeneck, the director for medical technology for Jabil Healthcare & Life Sciences.

As a result of this, many medical device companies are looking for help...

January 31st, 2012
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Hospitals spend around $17 billion annuallly on physican preference items such as pacemakers, artificial knees, and spinal discs.

 

 

Numbers, Infographic, Cardiac Valve Replacement, Spinal Fusion, Hip Replacement, Knee Replacement, Implants, Pacemakers, Stents, Hospitals, Physicians

January 30th, 2012
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Impending new medical device regulations in Russia are expected to make the regulatory system more streamlined. The regulations are expected to be released in the next few weeks. A blog post on medtechinsider details the expected changes in more detail.

One of the reasons Russia is changing its regulatory system is to make it easier for medtech manufacturers to export their products, said Sergey Tsyb, head of Department of Chemical Industries and Bioengineering Technologies within Russia’s Ministry of Industry and Trade, in an interview with EMDT Editor in Chief Norbert Sparrow last November. Medical device registration in Russia is challenging, especially for foreign companies, and you can't easily get answers by picking up the phone. According to the...

January 27th, 2012
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light bulb
Image from Flickr user Matthew Wynn

Co-founder of Sun Microsystems Bill Joy famously said: “No matter who you are, most of the smartest people work for someone else.” That statement has since gone on to be dubbed “Joy’s Law.”

So, assuming that declaration is true, it makes sense to look elsewhere to find genius—not matter where that else may be. There are many proponents backing this notion in, for...

January 27th, 2012
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NIck Woods, Hill Woods Medical Media
Nick Woods was a founding partner of Atlantech Medical Devices Ltd, until recently CEO of Tissuemed Ltd and now director of Hill Woods Medical Media Ltd and Editor of European Medical Device News Site, medlatest.com.

I’ve admired the U.S. medical device industry for 26 years now, from the perspective of being part of it and being an observer of it. I’ve attended congresses and marvelled at the sheer scale of the thing. I mean look at it... AAOS next month will again be a gigantic showcase of everything orthopaedic and goodness knows how many thousands of orthopods...

January 27th, 2012
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Image courtesy of Flickr user ultramega.

It’s a noisy world, and that is one of many reasons why in leak testing and other non-destructive testing, “accuracy” is not “accuracy” in the way that a rose is always a rose.

This is what I mean: if someone tells you that their leak tester can deliver 0.05% accuracy full scale for pressure decay leak testing, and let’s suppose...

January 26th, 2012
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