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I have breakfast once a week with a group of individuals with various backgrounds and professions. Since all of them work in or have customer relations, we sometimes get on the subject of the “worst customer I ever had.”

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

You know, the “Screamer” or the “Demander” or various other versions. My friend John and I were talking this morning about Mr. Demanding.

Usually you know when you are talking to Mr. Demanding, as the conversation sta

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

Examples of combination products may in

ts with their expectations and a list of tasks to be completed. In addition the world runs on their time. Does this sound familiar?

Pity the poor customer service professional who does not take the time to really listen

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

nd then decide the best course of action with Mr. Demanding. Dr. Covey’s principle “Seek first to understand, then to be understood” really needs to be the guiding thought here.

Here is the scenario. A vehicle is brought

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

into the shop for repair. Mr. Demanding recites the list of tasks to be performed and “I need to have the vehicle back this week.” He makes no bones about the need for the vehicle and how important it is to him as “time i

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

Combination pro

money and without this vehicle I am losing money.”

Our customer service professional can respond in several ways. He can be defensive and say something like “This is not a service we provide. (It actually is) I don’t 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

ink we can get it back to you in the time requested.” Or he can acquiesce and say “Sure, we’ll be able to handle that for you (and we’ll call you later and let you know that we can’t possibly meet the deadline) I’ll go a

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

ead and start the paperwork.” In either scenario the outcome can only be bad.

The first response is blunt and does not offer a choice. It merely throws up a defensive wall and allows Mr. Demanding to start a siege upon t

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

e wall. “Why not, it says you are a full service facility!” he states. “Is your signage wrong?” This exchange can lead only to a further defensive posturing by our intrepid customer service professional. The other respons

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

is equally unhelpful. By agreeing to the list presented by Mr. Demanding without clarification and understanding, our customer service professional can only disappoint and escalate the situation by calling later to apolo

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

ize “for not getting it done” on time.

The key here is to apply the “seek first to understand” principle and then formulate an action plan and statement. It might sound something like this. “Mr. Demanding, you have quit

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

Following aspects would a

e a list there. And I can see that there is a time constraint as well. Let’s take a moment and go over the list together and make sure I understand what we are doing for you.” Our customer service professional has just do

dd to the challenges in developing combination products:

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

e two things. He has reserved his judgment and shifted the focus to the facts. “I can see here that there are several items on your list that may take additional time to complete. If we start on these repairs, and it does

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

take additional time, can you still leave the vehicle with us?” Again, CSP has focused on the facts and given a choice to Mr. Demanding. There may be a further clarification and more action statements and choices. The fin

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

l key is to confirm everything that has been said and put it in writing. “Just so we are clear Mr. Demanding, I will be completing items 1, 2 and 3. If the repair is going to take longer than this week, I will call you an

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

update you by Weds. Is that how you understand it?” There are 3 major elements in making this work.

1st. Our CSP really listened and understood what Mr. Demanding was saying.

2nd. Our CSP not only listened, he demons

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

Professional from academic institutions, pharmaceutical industries, health care indust

trated that by giving Mr. Demanding an action statement and a choice. By offering choices, it allows Mr. Demanding to structure his schedule and decide the best course of action. Mr. Demanding can then decide if he wants

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

ll of the repairs completed or just some of them, and the rest to be completed at a later date.

3rd. Our CSP completed the deal by not only confirming the action, he wrote it down. Documentation beats conversation every

.

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

ime. By documenting our CSP is really demonstrating that he understands Mr. Demanding and his needs while providing the basis for a working relationship that is mutually agreeable.

By the way, John’s Mr. Demanding actual

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

Companies that provide selfless information through particip

y turned into Mr. Unhappy and took his business elsewhere, frustrated and angry even after approving the repair process. Proving once again the world is a strange and wonderful place full of strange and wonderful people

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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What the office of the future will look like in order to help increase productivity and profits and comfort and reduce pain.

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Bookkeeping is the process of maintaining records of various transactions of a business. The records include total revenue, gain, loss, expenses, dates of transactions, and many other details. Bookkeeping is the basis of accounting process and it is very important, no matter what business you are in.

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