Advice You - Business

Honest, Fair Feedback.

You want it. Everyone does.

Only trouble is, the more you need it, the less likely you are to get it.

Why? Research shows that 98% of us do one or

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

more of these three things when we have a difficult message to convey - and we think we're doing "the right thing":

-We Ease In: We try to make our point without being ob

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

Examples of combination products may in

vious about it. This can come out as:

Leading questions: "How do you think your presentation went?" (while privately thinking it was a disaster) or "Don't you think it wou

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

d be better to..." (while privately thinking it would be foolish to do anything else).

Or in statements that only partially share what we're thinking: "You might want to c

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

onsider another strategy." (while privately thinking that the current strategy has at least three major problems, and is costing the team its reputation)

-We Censor: We si

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

Combination pro

ply don't say what we're thinking at all.

-We "Data Dump": We just say what we're thinking. Plain and simple. If we're thinking the presentation was a disaster, we say it.

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

If we think it would be foolish to do anything but what we think should be done, we say that.

The problem? No matter which option we choose, we approach difficult convers

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

tions believing we're right. People who disagree with us are wrong. We understand the situation - those who see it differently don't. We have pure motives - those who disag

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

ree don't. And to make matters worse, we're usually unaware that we're thinking this way.

This way of thinking and these strategies dramatically limit the amount of useful

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

feedback we get and give - they also generate defensiveness. Judge for yourself - how do you respond when people approach you like this?

Changing the way you think and cha

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

nging the way you act creates a more productive option.

Here's what this new option looks like:

1. Try to keep your assumptions specific and linked to hard data - instead

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

Following aspects would a

of thinking "that presentation was a disaster," think "she didn't answer three of the board's questions, she yelled at Ted and Mary, she said she forgot to collect the cos

dd to the challenges in developing combination products:

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

data. I'm very concerned." How? A key question to ask yourself, or to ask others: "What did this person say or do that led me to believe this about them?"

2. Be Transpare

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

nt and Curious. Share your views, treat them as potentiallyright, and ask questions about what others think. Instead of saying "You didn't answer three of the board's quest

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

ons," say "I think there were three times when you didn't answer the board's questions (and give the examples). Do you remember that any differently?" For this to work, you

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

have to be genuinely curious as to the other person's view, and be open to missing something in some way. You also need to be consistent - these are not "tools" to be used

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

Professional from academic institutions, pharmaceutical industries, health care indust

when it's convenient or comfortable to do so.

How would you react if someone gave you feedback in this way?

For us and our clients, thinking and acting this way has a few

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

key benefits:

-It greatly reduces defensiveness - yours and others'.

-It significantly increases learning: you both get the specific, candid feedback you want, and can m

.

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

ke specific, powerful changes if you wish.

-Because you're being genuinely curious, and saying what you're thinking, there's an important additional side-effect of all thi

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

Companies that provide selfless information through particip

s: increased trust and higher quality relationships.

What are your reactions to all this? Please come to the Mutual Learning Action Group and share them.

© 2005 Matt Bean

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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