Subjects - Business

Open-ended questions are a good way to start responsive, productive conversations. They elicit complete, thoughtful answers that reveal what's important to the person responding. They're used by teachers to help stu

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

dents think and by friends to help friends feel heard and comforted.

More importantly, open-ended questions help create common goals, resolve disagreements, and close up the distance that can grow over time between

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

Examples of combination products may in

friends, family, and partners.

In both work and personal situations, caring and sensitive people pride themselves on crafting their open-ended questions with, well, caring and sensitivity.

So why don't they get the

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

results they want? Why do they continue to struggle with misunderstandings, disconnects, and the gradual slide of previously-close relationships into a frustrating lack of communication?

They're asking the wron

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

g open-ended questions.

Sometimes you know right away when you've asked the wrong question. If the response you get is confused or, worse, angry and reactionary, you've got a pretty good clue. And that's a goo

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

Combination pro

d thing, because it allows you to try something different right away.

But sometimes you get a reasoned, apparently responsive answer. You have a great conversation - you'd even call it a productive discussion. You

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

feel that you've made progress and that change is underway.

And nothing happens. Maybe things even get worse. You wait patiently (or not so patiently), and then you try again, asking the same question since it go

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

t a good answer the first time - and anyway, you really do want to know the answer!

You may be getting clear, thoughtful answers, but if you're not getting the results you want, you're asking the wrong question.

Wh

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

en you want a change to happen in your relationship with someone, the questions you ask must be meaningful in terms of how the other person views the problem.

That's a key point, and bears repeating.

If you'

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

re in a relationship, whether at work or at home, where you feel something needs to change, you must frame your questions so they address the other person's viewpoint. If your questions come only from

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

your viewpoint, they won't - can't - achieve your goal of creating change, even if they lead to a terrific conversation.

For example, if your co-worker is missing project deadlines, you might ask how you can

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

Following aspects would a

help him finish his tasks on time. His answer might be perfectly reasonable. But if he's missing deadlines because he thinks the project schedule is impossible, he won't get any better at meeting them because you'v

dd to the challenges in developing combination products:

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

e asked how you can help.

Likewise, if your spouse is putting in a lot of overtime, you might ask her how she feels about not spending more time with you. She might reply that it really bothers her, and you may hav

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

e a great conversation about how she could establish better boundaries with her manager. But if she's been promised a promotion or if she's excited by the project, she's not going to be coming home any earlier.

If

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

you've been asking open-ended questions that lead to what seem to be productive, responsive conversations, but you're still not seeing the results you want - then it's time to stop and think. What can you ask that w

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

ill draw out the real problem?

You might ask your co-worker how he feels about the deadlines assigned to his tasks. And you might ask your wife how she feels about the project she's working on. In these examples,

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

Professional from academic institutions, pharmaceutical industries, health care indust

those questions are more likely to get you closer to understanding what's really going on.

Of course, I've given away the secret by telling you the other person's point of view. It's not quite so easy in real life.

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

In real life, you often have to try several times before you find the right question. And to do that, you'll have to put yourself into the other person's situation, which can be both difficult and painful.

.

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

It comes down to asking yourself the question of how much you want the change to happen. So my question for you is, what relationships are you in that could use some improvement? And what new questions can

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

Companies that provide selfless information through particip

you ask to help make those changes? Drop me a line and let me know how it goes!

"It is better to know some of the questions than all of the answers." James Thurber, U.S. humorist and cartoonist, 1894 - 1961

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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