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It was foggy early yesterday morning, as I stepped out the back door to go for a run. Not just a little bit foggy either. No, I’m talking pea soup, where did my house go, Hound of the Bas

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

kervilles, foggy.

It was strangely quiet, and I have to say that I found running through this dream-like stuff quite enjoyable. In fact, it was only after the second car nearly ran me down t

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

Examples of combination products may in

at I realized there was a problem: They couldn’t see me.

As someone on foot, and despite the heavy fog, it was easy to see the ground in front of me, thanks to a five foot bubble of open sp

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

ce that moved with me as I ran. But for a car going 40 miles per hour (that’s about 973 stones per hectare, for those of you on the metric system) it was a different story. They couldn’t see me

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

ntil they were almost on top of me, which, I don’t mind telling you, made me a bit uneasy.

As I ran, I considered my options:

1. Stop running, and wait for the fog to clear.

2. Remove

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

Combination pro

ll of my clothes, in the hope that the reflection off my pasty, white, middle-aged body would serve as a warning beacon for approaching vehicles. (Sorry, take a minute to let that image pass.)

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

. Change my route, and turn off onto less heavily traveled side streets.

As I’m sure you’ve guessed, I chose option three. And, I’m happy to report, after some twists and turns, and only

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

getting lost once… I got hit by a school bus. Ha ha!, I’m kidding. I arrived home safely.

Here’s the point. As a runner, you can cover the same route, in the same clothes, wearing the sa

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

e shoes for months on end, and have great success. In a very short time however, and through no fault of your own, the environment can change drastically, making it hard to see your way and l

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

aving you at risk.

By the same token, as a professional firm publishing an E-Newsletter (or for that matter, as a business providing a particular service), you may find that what once worke

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

well, no longer does. Often – and again, through no fault of your own – it’s not because you’ve run off course but simply because the course itself has changed.

It’s for this reason

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

Following aspects would a

that I recommend stepping back periodically, to take a look at your newsletter, and make sure that the world you’re writing to hasn’t evolved in some critical way. Two important questions to

dd to the challenges in developing combination products:

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

ask in this regard:

1. Has your audience changed?

When I began this newsletter in 1999, I was writing for small business owners. Over time, I realized that my particular approach – one

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

undamentally based on useful content and strong relationships – was suited to a particular type of business (i.e. professional service providers), rather than businesses of a particular s

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

ze. So step one is to see if the people you’re writing to are still the right people.

2. Is your topic still relevant?

Here as well, this newsletter has changed over time. While it

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

sed to focus primarily on "E-Newsletter mechanics" (e.g. click tracking, formatting, opt-in processes), today, I hardly talk about these kinds of things at all.

As the e-mail world has evolv

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

Professional from academic institutions, pharmaceutical industries, health care indust

d, the challenge for a professional service provider seeking to produce an effective E-Newsletter is no longer a technical one. The problem we all face in 2006 – in a world where nobody want

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

any more e-mail – is to write something that other people will be eager to read. So that’s what I focus on now.

How about you? How might the interests of your audience have changed since yo

.

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

began publishing?

Bottom Line. In producing an E-Newsletter for your business, the place to start is always with you: Your voice, your expertise, your point of view, etc. Keep in mi

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

Companies that provide selfless information through particip

d however, that this is only half the equation. Who you’re audience is and what they consider important today, is equally vital.

(c)Copyright 2006. Blue Penguin Development & Michael Kat

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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Today advertising is a questionable effort both to build recognition and to build a brand. The academic elite as well as business professionals have a second thought how to do. It's all about building a trustworthy and reliable partnership with your (future) customers. To become a part of their mind so to speak.

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