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If you work as an organizational consultant, you are sure to hear all types of request from clients. Instead of consulting with you the client actually brings you a solution that he or she wants implem

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

ented. You know that following that line is the wrong thing to do and more importantly it will not provide your clients with the results that they are look for.

So, what do you do?

This is the story of one

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

Examples of combination products may in

f my favorite client engagements. I call it "Disconnecting the Phone Doctor." Take a look at the client's request and you'll understand why.

THE TRAINING REQUEST

The manager said that he had 125 peo

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

le in the technical center and that they had recently experienced an 8% drop in our customer satisfaction and responsiveness ratings. Customers reported that the phone rang too many times before being answered

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

the hold times were too long, and sometimes there was no answer at all. The customers said that they had to call back to get an issue resolved.

Could you please deliver "Phone Doctor" training?

The “Phone

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

Combination pro

octor” is a training class to teach people better phone etiquette. This was a sophisticated telecommunications network center staff with telecom specialist, engineers, and systems professionals. The center wa

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

responsible for building client networks, monitoring the networks, and troubleshooting network failures.

MY IMMEDIATE THOUGHT

If performance was good what caused the 8% drop. I don't seriously think

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

that it is because people don't know how to answer a ringing phone or speak when they answer it. After all they all had telecommunication or information technology degrees and they had communicated well enough

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

to get the job.

THE FINDINGS

This manager had hired 15 new people within a 45-day period. Someone had the bright idea that the best way to get the new people up to speed was to immediately expose them

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

to the types of issues that they would be handling. Management decided to assign the new people to phone detail. They were to answer very technical telecommunication network calls from experienced technicians

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

at their client locations.

Without knowing what to say, the new technicians would place people on hold and walk around the center looking for assistance. Though they would try to repeat what was told to them

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

Following aspects would a

uch was lost in translation. They did not know the job, the processes, the terminology, or the needs of the clients.

THE RECOMMENDATION

I immediately refused to deliver Phone Doctor or any other type

dd to the challenges in developing combination products:

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

of verbal communication training. I suggested people be removed from the phones. The manager agreed with the first part but said it would take time to reassign people.

THE PLAN

I grabbed two m

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

re team members from my group and asked the manager if we could have eight hours to gather information from the people. He agreed.

In about six hours we conducted face to face meetings with the five top p

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

eople in the group. We learned that there are five common technical problems and reasons why customers call into the center.

We spent time with five new people to understand their challenges and what they

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

absolutely needed to know.

We created job aids for each of the five call types. We developed the 5 questions that are usually asked by the customers and prepared the answers. We included directions as to

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

Professional from academic institutions, pharmaceutical industries, health care indust

when the "newbie" should go for help and how to position that with the customer.

THE CLASS

Two days later I returned and taught a full-day class on the 5 primary calls and how to handle them. I m

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

de sure that the new techs had the right tools to answer the questions and also knew what to do when they were stuck. I allowed 1-hour for them to interact with existing techs to ask questions.

THE RESULT<

.

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

b>

1 day of assessment, 2 days of development, 1 day for delivery.

On hold times went down.
Calls were answered in fewer rings.
Customers were more satisfied with the answers.
Custom

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

Companies that provide selfless information through particip

r made fewer calls back.

Employee confidence went up.
Employees were more engaged.
Employees learned a great deal in a short time.
Employee increased their own learning with every call.

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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