Main Subject - Business

Customer “Hot Button” is a term that describes the important information we must find and retain during the questioning or dis

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

covery process. Without these hot buttons we cannot even begin to offer a product or service. Why? Because we don’t know what they need. We may think

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

Examples of combination products may in

we know – but we really don’t. Not yet. This important information we are looking for can be separated into two categories: Absolutes and Prim

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

ary Motivating Factors.

Absolutes are the specifics the customer wants from your product or service. It may be timely delivery, competiti

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 value, or quality. This can be determined simply by asking a great open question like…

“What is important to you when selecting

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

Combination pro

product x?”

Primary Motivating Factors are the real reasons the customer needs your product or service. These are th

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

e emotions behind the logic or the reason why they want your product now. We learn and understand primary motivating factors by asking another good open qu

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

estion like…

“Why is that important to you?”

After we completely understand the cu

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

tomer’s situation through good questioning and careful listening, it is important for us to summarize back to the customer what we think we have just

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

heard. The final step during the discovery phase of a sale is to confirm with the customer that we truly understand their situation. We d

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

o this by repeating back to them what we have learned and asking the customer whether or not we are correct. The discovery summary shows the customer that

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

Following aspects would a

we are listening and paying attention and concerned about his/her needs. It also commits the customer to an unspoken contract.

“If you m

dd to the challenges in developing combination products:

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

et these needs, I’ll give you my business.” The Discovery Summary

If

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

you follow this simple format, your discovery summary will flow nicely and sound very organized to the customer. Keep in mind, up t

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

o this point in the conversation you have been listening at least 60% of the time...so this should be no problem – right?

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

>Introduce the summary: "Let’s review what we talked about to make sure I understand your situation…"

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

Professional from academic institutions, pharmaceutical industries, health care indust

g>Bridge into summary: "Your current situation is…"

Bridge into desired situation: &quo

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

t;The right product would allow you to…"

Confirm your summary: "Does that accurately sum up your

.

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

situation? Did I miss anything?"

Finding the true needs through simple open ended questions combined with the power of a discovery summary

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

Companies that provide selfless information through particip

can really turn up the heat for your customer. If you have done a good job digging for the real needs and summarizing then you are ready to ask for action

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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