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Most professionals take pride in the work they do. Dealing with complaints is often challenging and upsetting. It is very natural to try to exp

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

lain or justify what was done. The suggestions I have made in this list are not easy to do in the heat of a situation. So when you hear a compl

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

Examples of combination products may in

aint about you or your business/practice perhaps the best strategy is to count to ten and then do some of the following:

1. Listen – Resist

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

he temptation to argue with the client. Instead ask questions to get to the bottom of the situation. What is the client really upset about? Sho

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

w the client that you really understand the situation from the client’s perspective.

2. Don’t be defensive – This will get in the way of your li

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

Combination pro

stening to the client. Allow the client the time and space to be heard. If you get defensive you’ll build a wall between you and the client. T

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

y to find ways to build a bridge so that you are aligned with the client.

3. If you agree that it was a mistake, fix it immediately or do what y

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

ou can to satisfy the client and apologize. We all make mistakes at times. Check to see if there is anything in your office procedure that can

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

help you to avoid a similar mistake again.

4. For a more complex issue research the problem before you make any decisions. Find out what actual

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

y happened. Is a system in your office not working correctly? Does it need to be fixed? Has the client misunderstood something? Give yourself

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

time to figure out a fair resolution.

5. Look for lessons in the situation – If the situation was caused by something you or your staff control

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

Following aspects would a

, find a way to fix it for the future. This means assessing the systems you have in place and your methods and procedures. It also may mean retr

dd to the challenges in developing combination products:

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

ining an employee or employees.

6. Reeducate the client when necessary – How did you set client’s expectations? Were you clear about what he/sh

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

e could expect? Help the client to understand the process now to guard against future misunderstandings.

7. Know that if one client complained

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

there are others feeling the same way. What do you need to do to address the problem with the others? Who else might have been affected in the

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

ame way?

8. Give the client choice of possible resolutions. How can you make this right with the client? Negotiate a way that works for both o

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

Professional from academic institutions, pharmaceutical industries, health care indust

f you. Sometimes just fixing the problem is sufficient. At other times the client is looking for something else. Look for an equitable resoluti

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

on.

9. Thank the client for helping you with your business. As painful as they can be complaints from clients often let you know exactly where

.

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

ou need to work to improve your practice/business.

10. Follow up with those who complained to be sure they are fully satisfied. If you have alt

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

Companies that provide selfless information through particip

ered a system or changed a way of doing business and the client is affected by that change, follow up to be sure that the client noted the change

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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By definition, barter is the when parties swap services or resources. But in business terms, it’s an exchange that ends usually with everyone a winner. All parties involved in bartering hold onto their cold hard cash and don’t lose a cent. There’s no worries about getting ripped off as a buyer or seller, so it’s an exchange that’s high on trust, low on tension. And finally, the government doesn’t get its hands on any of the proceeds. Bartering is such a great system, it’s no wonder it’s been around nearly forever.

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