Digg It - Business

How we use questions to get more commitment, learning and better results.

Two weeks ago, Sue McKinney, Peg Carlson and I spent four d

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

ays training a group of internal Continuous Improvement consultants. They noticed two things about us and our approach:

-We ask a lot

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

Examples of combination products may in

of genuinely curious questions
-We actively seek disagreement and difference

Many of them noticed the opposite patterns in them

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

elves! As they practiced their newfound skills, we all noticed that they would often advocate for something and then ask questions lik

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

e "Are you ok with that?", "Am I right?" or "Do you agree?" We also noticed they were silently hoping that they'd get quick agreement

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

Combination pro

so they could move on.

We talked with them about their questions. We decided that their questions were likely to solicit agreement or

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

similar views. They also made it harder for others to openly disagree.

We suggested a different way of thinking: if they genuinely wa

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

nted solutions that people were internally committed to and they wanted them quickly, they would be better off saying what they were t

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

hinking, then actively seeking disagreement.

Time and again, we've learned that if people disagree or see things differently, we save

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

time by discovering their views as quickly as possible. We suggest you ask questions that actively seek disagreement or that encourage

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

people to respond with whatever they're naturally thinking. Here are some examples of each:

"Seeking Disagreement" questions:
"

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

Following aspects would a

I'd like to use [x] as a vendor. Do you have any concerns about [x]?"
"I'd like to... Does anyone see any problems with what I'm

dd to the challenges in developing combination products:

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

uggesting?"
"I think you have concerns about this project. Am I off base?"
"I think we'd save time by building an agenda. Ar

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

e you seeing that differently?"
"I think this market will be profitable because.... What flaws, if any, do you see in my logic?"

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

"Natural Thinking" questions:
"I think production in unit A has slowed. What do you think?"
"I'm concerned that we don't ha

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

e enough support from Jim and his team. What's your reaction to that?"
"Sounds like you think [x] is the best way to go. What is

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

Professional from academic institutions, pharmaceutical industries, health care indust

it that's important to you about [x]?"
"It sounds like we've missed our deadline. Have I done anything to contribute to this prob

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

lem?"

We've found that getting these questions out your mouth in a believable way requires you to be genuinely interested in surfacin

.

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

differences and disagreement. If you aren't, they will probably come across as canned, perfunctory, or even manipulative.

What are y

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

Companies that provide selfless information through particip

our reactions to all of this? Please come to the Mutual Learning Action Group and share them with us and your peers.

© 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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