Main Subject - Business

When you are trying to spread best practices throughout your organization, you may realize that you need help in communicating those practices effectively. Wise managers unders

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

tand that sharing best practices in ways that truly impact employee performance takes highly specialized skills.

Unfortunately, once they start looking for ex

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

Examples of combination products may in

ternal help, these same wise managers can become a little forgetful. They forget that the problem they identified was a lack of skill, communication a

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

nd writing skill. And they start focusing almost exclusively on finding someone who already has detailed knowledge of their industry, their methods and processes, or their prod

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

ucts and services.

Why pay for the same expertise twice?

Remember, you started out by identifying a gap in capabilities, an obstacle to spre

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

Combination pro

ading best practices among your team. The gap was in the skills to get the message across, not in the knowledge that goes into the message.

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

You can easily waste a lot of money by hiring someone who knows everything you know, without the writing and communication skills you actually want.

It is easy to see how this

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

happens. Generating a quantity of clearly explained content, easy to read and understand, with a real impact on employee behavior . . . well, that's something you may find eno

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

rmously challenging, even stressful. You'd rather focus on other activities you're more comfortable with, more confident about.

Then you discover that some bu

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

siness writers bring a little different perspective to your topic, trying to "translate" your content into more digestible form for people who are not intimately familiar with

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

our products, services, or procedures. You find it easier to talk to the writers who are more keenly interested in the facts, specifications, and details of your topic than in

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

Following aspects would a

the writing end of it.

After all, two experts don't need any "translation" to talk to each other. You feel more at home dealing with someone who already speaks your language f

dd to the challenges in developing combination products:

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

luently.

That makes your project meetings more comfortable. But how does it help you influence your real audience: people who do not already speak your language?
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ng> How does another helping of the knowledge you already have help you connect to the cautious, unaware, unconvinced employee, prospect, or customer?

You really
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
do need someone who thinks a little differently, who is focused on communication methods rather than precise specifications. Good business writers offer you that
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
"translation" ability, that awareness of another perspective and the skill to turn what you say into what others need to hear to understand you and follow you.

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

Professional from academic institutions, pharmaceutical industries, health care indust
if they have some familiarity with your industry. But given the choice between communication skill and detailed technical knowledge, go for the skill.

You've
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
already paid for the knowledge at least once, through your employees, product developers, procedural consultants, and other experts. Paying for it twice will not add any impac
.

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
t to your message, and you'll probably find that you have short-changed the skills you needed most. Hire help that complements, rather than duplicates, your t
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
eam's capabilities.

Get help that truly contributes to your success, and not just to your comfort level!

© 2007 Best Training Practices -- Will Kenn

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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Main Subject - Spreading Best Practices - Are You Paying For The Same Expertise Twice?

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