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“We are not to avoid the Holiday rush. We are to avoid rushing the Holiday.” Rev. Bill Pfohl.

It’s official. The world can be divided yet one more way: those who doorbust and those who don’t.

Surely you’ve heard the term by now. It refers to folks who get up pre-dawn— most notably on “Black Friday”—an

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

d literally bust through stores’ doors as they open in the morning for business. This lovely little ritual is just a few years old...and it appears that it’s starting earlier in the day and attracting more and more devotees each year.

As several of my friends engage in this practice, I can’t put it dow

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

. My understanding is that those folks who doorbust think it’s the most normal thing in the world; those of us who wouldn’t be caught dead doing so think they are absolutely nuts.

Talk radio on Friday morning was loaded up with discussion on this phenomenon. Shockingly, the calling audience overwhelmin

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

gly felt that doorbusting is actually a rather virtuous practice. That is helps teach kids the value of a hard-earned buck. That those who engage in it exhibit perserverance. Work diligently for what they want. Are willing to sacrifice sleep and comfort in order to get it. Are smart spenders. Exercise g

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

od stewardship.

Me? It was a mute point, as I needed to get Nick to the doctor for his weekly check-up (for leukemia). Couldn’t have doorbusted even if I wanted to. And I cannot imagine—even in my wildest dreams—the mere thought. Hate crowds. Hate standing in lines. Hate standing in lines in the cold.

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ate giving up my morning coffee ritual. Wouldn’t dream of leaving my warm bed in the pre-dawn cold and dark.

I admit, however, to once again feeling overwhelmed by my long shopping list for Christmas and would love—as my doorbusting friends can now boast about—having it nearly finished. Gifts bought, w

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

rapped and ready to ship. I face frustration once again as I contemplate how to most graciously allow the true spirit of Christmas to enter my family’s reality while meeting all of the season’s demands. Of heeding my pastor’s advice in this week’s sermon: “We are not to avoid the Holiday rush. We are t

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

avoid rushing the Holiday.”

Every year, at about this time, I make my gift list, review those of the past few years, and resolve to be more clever, more thoughtful and more efficient. Every year, at about this time, I under-budget the three most important factors—time, money and energy—for getting my

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

act together. And every year, at about this time. I submit to some of the inevitable: mall-shopping, post-office waiting and last-minute ordering. I resolve—year after year after year—to “be better.” And yet, to keep my eye on the ball. To remember that this season of Advent is to help us move closer to

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

the Christ child. To deepen our relationship with Him.

So where does that fit in? Where, amongst the parties and the pageants, the cookies and the cards, does the message of Christmas weave itself into the fabric of these next four weeks? How does one remain true to the message and yet live in consiste

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

cy with cultural expectations? Gift-giving is one of the mainstays of the Holidays. And yet it exacts an emotional, financial and physical toll. Whether we like it or not.

For whatever they’re worth, these are my guideposts for preparing for and celebrating the Holidays with vigor and verve:

Think nat

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ural. There’s just something about natural beauty. In faces, fashion and home decorating. Friends this year will get gifts from the outdoors or from my local garden center: flowers, bulbs, topiaries. Clay pots, sphagnum moss and all. No gloss. No shine. Simple.

Think small. It never fails: just wh

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

n I think I’ve outsmarted the system and have figured out perfectly well the exact postage for my smaller packages, I wind up making three or four long trips to the post office with a half a dozen boxes in my arms each and every time. This year, I’m thinking small and lightweight. Gifts that can be eas

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ily stuffed into small padded envelopes. With pre-determined, pre-affixed stamps. Stationery, note cards, writing tablets. Jewelry. Smart.

Think homebaked. I adore receiving homemade cookies, as I almost never bake in my own home. (Not my thing.) And so I assume that others love receiving them as muc

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

as I do. I never forget our family’s time-honored hands-down best Christmas cookie: Ritz-cracker-peanut-butter-sandwiches-dipped-in-dark-or-white-chocolate. Packaged in pretty tins or boxes, they remain a perennial favorite, and will find their way onto my kitchen counter as well as into a few brown pa

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

kages this year as they do every year. Easy.

Think handmade. I always think that this Christmas will be different: that I’ll paint large quantities of miniature canvases in oils, hook multitudes of stockings out of hand-dyed wool, decoupage glass plates for all of my neighbors, or needlepoint belts f

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

or all four of our kids….and then life gets in the way. Amidst the hustle and the bustle, I invariably wind up at my favorite local merchant, filling his counter with a dozen or so of my favorite things, and giving said item to each and every one of my girlfriends—whether she likes it or not. Not necess

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

rily the most thoughtful approach, but certainly one of the most expedient. But if I can time it just right, I’ll be tinkering in my studio this year, trying to create something out of my heart. Using my own hands and investing time more than any other ingredient. Honest.

I admit: this approach only wo

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

rks for the grown-up set. Girlfriends are amongst the most appreciative set I know. But as for all the little tykes on your list: give it up. You’ll find yourself at more toy stores than you ever thought possible, searching for talking dolls, action-packed video games, new bikes and glow-in-the-dark bal

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

s. And you’ll spend way more of those special three—time, money and energy—than you ever planned. As for those teens on your list? My own daughter is so hoping for Juicy Couture and I am so hoping that they’re all sold out. Malls and madness. Yuck. The mere thought exhausts me.

If only I had doorbusted

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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The world of headsets has evolved greatly over the last decade or so. When headsets were first invented, all of these pieces of equipment were bulky and never considered to be portable in nature. As the years have passed and technology has made headsets more compatible and have more features, these devices have become more popular.

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