Useful Advices - Business

When you are driving down a road, you'll sometimes encounter a roadblock, which prevents you from getting to your destination. If you are unfamiliar with the area, you might get

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

lost or go miles out of your way before you get back on track. If you lived locally, though, you would know the back roads and alternate routes to help you arrive stress-free and

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

Examples of combination products may in

on-time.

In the business world, you may also encounter roadblocks—which are communication breakdowns or roadblocks that prevent you from meeting your initiatives.

More specific

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

lly, when your corporate team doesn't meet a crucial deadline or deliver a desired outcome, it is often considered a sign of a low-performing team or poor leadership on your part.

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

And, these roadblocks are often an impediment to your forward progress, your communication, and your ultimate success.

The roadblock many business leaders encounter is simply t

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

Combination pro

e ways in which people interact with other people in order to achieve their goals. Just as locals understand the back roads, wise leaders understand the underlying dynamics of co

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

mmunication, knowing how to effortlessly navigate the potholes and smooth out their ride.

So what is the alternate route, the "back way" around communication roadblocks? Expert

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

ommunicators understand the power of needs, and the needs of those on their team.

For example, the physical needs of those on your team include air, water, food, shelter. And th

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

en personal needs are defined as what they must have to be themselves, but often are not able to get "enough of", for example, recognition, power, or security.

Of all the persona

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

needs that drive us, there are Seven Universal Needs that are found in people around the world:

1. To be needed and valued
2. To be recognized
3. To feel hope (vs.

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

despair)
4. To be right
5. To be understood
6. To be important
7. To have power

The Seven Universal Needs often become Values if we don’t think through what

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

Following aspects would a

is important to those on your team. When executives in the business world come under attack, it is because their underlying values, such as their need for wealth, power, and rec

dd to the challenges in developing combination products:

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

gnition, were not closely examined. GillenGroup/Roadblocks Page 2

Without awareness, underlying values will be the driving factor in all your decisions and the decision

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

s of your team. This is where the Enron team ran into trouble. Their need for wealth and power drove them to make self-serving decisions. And their need to be right/not wrong p

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

evented them from admitting the company was in trouble.

Tips to leveraging the Seven Universal Needs:

6. Look closely at the needs list and start working on your own needs/

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

values.
5. Ask yourself, "Who do I want to be?"

"What is the highest and best I can be?"

"How do I want to feel?"
4. Listen to others and ask, "What are thei

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

Professional from academic institutions, pharmaceutical industries, health care indust

underlying needs?"
3. Find one thing about this person you admire. Now tell them!
2. Recognize when your own needs are surfacing. Ask yourself the questions in #5

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

And the #1 Tip:

1. Help each person get what they want by meeting their needs -- and you'll get what you want!

When you recognize that others are fabulous just the way they are

.

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

and look for what their needs are, your life gets easier…and well on your way to leading a loyal, motivated team!

Would you like a list of needs to examine what your underlying n

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

Companies that provide selfless information through particip

eeds are? Send an email to kathy@gillengroup.com with "Needs list" in the subject line and we'll send you this tool.

Copyright 2006, Strategic Management Partners, Inc.

Doc #73

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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