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First, for those of you who have seen me live, you know that I am big on questioning your p

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

rospects during the qualification stage. As I’ve said -- they have all the answers as to w

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

Examples of combination products may in

y they'll buy or not buy, and it is your job to get them to tell you.

While asking questio

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

s is certainly a good start, you'll get the most thorough and complete information if you u

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 layering questions.

Layering questions are simply questions that go a little deeper into

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

Combination pro

an area or concern so that you get to the root of what really drives your prospect.

An ex

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

mple of a layering question goes like this: “Who are you going to be talking with about th

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

s decision?" (A nice assumptive question). And when they say their spouse, you then layer

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

he question by asking – “And what do they think you should do about this?"

Knowing this ki

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

nd of information gives you the edge when it’s time to close. And layering questions are ex

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

ctly what you use to get it.

Layering questions are effective, powerful and easy to ask.

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

Following aspects would a

et 80% of sales reps never use them. The top 20%, on the other hand, know their value and

dd to the challenges in developing combination products:

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

sk them all the time. It's part of what makes them the top 20%.

Examples of other layerin

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

g questions you can use:

“If you decide to move on this investment, how much would you put

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

into it?"

Layering question: “And is that money liquid now or would you have to move some

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

hing around?"

Another

“I'll get this quote off to you today, and I'll follow up with you

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

Professional from academic institutions, pharmaceutical industries, health care indust

omorrow at 10 o’clock – would that work? Great"

Layering question: "Assuming you like it,

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

what is the next step?"

I'm sure you see how this goes, so take a few minutes now and wri

.

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

e some of your own. And then use them!

Coaching

What if I told you there was a way for y

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

Companies that provide selfless information through particip

u to invest $500 a month and get back $1000. Or $3000. Or $5000 or more. Would you do it

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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