UDI

A Quick Note About The UDI Conference September 18 & 19, 2012

August 17, 2012 Dirk Rodgers 2 Comments

The FDA is co-sponsoring an important two-day conference in Orlando on September 18th and 19th, 2012 that will cover their plans for medical device Unique Device Identification (UDI). Today is the last day to get their early-bird registration rate of $695 so act fast.

But I know a way to get another $100 off of the early, the advance and the standard registration fees. When you register, simply put the letters “RX” in the “Promotional Code” field of the registration form. That lets them know that you are a special RxTrace reader and deserve to pay less. Remember, it works on all registration levels.

I’m going to have a lot more to say about the FDA’s UDI proposed rule in the coming weeks but Continue reading A Quick Note About The UDI Conference September 18 & 19, 2012 →

Pelotonia

Pelotonia 2012…180 Miles!

August 15, 2012 Dirk Rodgers

I missed my self-imposed Monday deadline for an RxTrace essay this week because I am still recovering from the Pelotonia cancer research fundraiser bike ride that I participated in over the weekend. This year I roused the necessary donations, plus my own contributions, to be able to ride the full 180 miles over the two day event.

I have ridden in the Pelotonia since its inception four years ago and I can say beyond a doubt that Continue reading Pelotonia 2012…180 Miles! →

HDMA

Standards and Guidance For U.S. Pharma Supply Chain Technology

August 6, 2012 Dirk Rodgers 1 Comment

[This essay is one of two long lost essays that have now been restored on RxTrace. It was originally published on November 22, 2010. See “Return Of Two Classics” for an explanation.]

In my last essay, “Who Will Decide Which Pedigree Model You Will Invest In?” I pointed out how easy it is to get confused about pedigree technology because of varying claims made by certain companies who have interests that don’t align well with yours. So where can you get better information? I can provide you with a few good sources, and I will also tell you about a missing ingredient that I see in the current guidance landscape that will need to be addressed in the next couple of years. Continue reading Standards and Guidance For U.S. Pharma Supply Chain Technology →

serialization

InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2012

August 1, 2012 Dirk Rodgers 1 Comment

In August 2010 I started an annual estimate of the rise in the percentage of drugs in the U.S. supply chain that will have serial numbers attached. Click here to read my first essay on the topic which explains the concept. Click here to read my 2011 essay. These are not estimates of the actual percentage today. Rather, it is a prediction of the rise from an immeasurably small percentage in early 2010 to 100% at some time in the future. My plan is to Continue reading InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2012 →

RxTrace

Return Of Two Classics

July 30, 2012 Dirk Rodgers 1 Comment

Today I am republishing one of my long lost classic essays, “Who Will Decide Which Pedigree Model You Will Invest In?“. This essay was first published on November 15, 2010 but was removed from public view in December of that year. Next week I will republish the second long lost essay, “Standards and Guidance For U.S. Pharma Supply Chain Technology“, originally published on November 22, 2010. Both of these essay contain my thoughts on how the industry will eventually resolve the current confusion over which approach to ePedigree everyone in the U.S. supply chain should take. Check them out and see if Continue reading Return Of Two Classics →

California Pedigree Law

Who Will Decide Which Pedigree Model You Will Invest In?

July 30, 2012 Dirk Rodgers 5 Comments

[This essay is one of two long lost essays that have now been restored on RxTrace. It was originally published on November 15, 2010. See “Return Of Two Classics” for an explanation.]

In one of my most widely read essays, “RFID is DEAD…At Unit-Level in Pharma”, I pointed out that the choice of serial number carrier technology to be used for compliance with the California Pedigree Law would be decided solely by the pharmaceutical manufacturers. I pointed out that most of them would end up choosing 2D barcodes because their ongoing costs for Radio Frequency IDentification (RFID) would be too high.

Since the law doesn’t specify a carrier technology, and because the manufacturers will foot the bill for whatever technology is used, naturally, they get to lead the supply chain in that choice. If you don’t like what they are choosing, then please, step up and pay them to put your preferred carrier technology on their packages. I’m sure the manufacturer’s would put whatever you want to pay for on their packages as long as it would comply with the law.

But what about the pedigree model that the supply chain will use for compliance? Can we apply similar logic to determine who will get to choose the technology that defines what a compliant pedigree is? Yes we can! And here it is. Continue reading Who Will Decide Which Pedigree Model You Will Invest In? →

Pelotonia

The Good News About Cancer Treatments

July 23, 2012 Dirk Rodgers

Dirk Rodgers.Pelotonia.2010.142x200 — Photo by Tony Basa

I haven’t had cancer yet, but according to the American Cancer Society there is a 45% chance that I will contract some form of it before the end of my life. The same goes for you if you are a male. For women, the statistics aren’t quite so bad. You have “only” a 38% chance of contracting cancer before the end of your life.

On the other hand, the Mayo Clinic encourages us to view these statistics very carefully.

“Just because studies have found that men have a nearly 50 percent chance of developing cancer in their lifetimes doesn’t mean that your risk, if you’re a man, is 50 percent. Your individual risk is based on many different factors, such as your age and habits, your family history of cancer, and the environment in which you live.”

Well said. I would add that it also greatly depends on if you, or someone close to you, uses tobacco or not. The point is, some of us have a much lower risk of developing cancer and others have a much higher risk than these averages indicate.

For many people, looking at their family history regarding cancer can be scary, but it is the first step Continue reading The Good News About Cancer Treatments →

Dirk Rodgers Consulting LLC

Announcing, Dirk Rodgers Consulting, LLC

July 16, 2012 Dirk Rodgers 11 Comments

After a month of intensive preparations I can now finally announce that I will leave my current employer on July 27, 2012, and on the following Monday I will open the books on Dirk Rodgers Consulting, LLC. As many of you know, I have filled the role of Sr. Consultant in an full-time internal position at my employer for the last 3 1/2 years. I will now be able to help clients navigate the same intersection between the pharmaceutical supply chain, track and trace technology, standards and regulatory compliance that I have written about for the last three years.

Over those three years I have been approached by a number of companies who were looking for quality help with their special problems in this realm but I was forced to turn them down or refer them to other consultants because I already had a full time job. From now on I will be able to offer my own expertise instead.

I have pulled together a new website to market my services at www.DirkRodgers.com. So far it is pretty minimal but through the fall I intend to expand the information it contains and establish more formal offerings. If you know of someone in need of help with knowledge and strategy in the areas I write about, please refer them to either RxTrace.com or DirkRodgers.com.

SO NOW WHAT BECOMES OF RxTRACE?

The creation of Continue reading Announcing, Dirk Rodgers Consulting, LLC →

…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance