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Legendary Service.

Many organizations use this phrase to describe and promote their service. But how many have really earned it?

If you give good service, that’s

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

not legendary. If you go out of your way for someone, that’s not legendary either. But if you provide service unsurpassed in your field, that can be legendary ser

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

Examples of combination products may in

ice.

Many years ago I lived in the northeastern United States: cold winters, lots of snow, great skiing. I bought a pair of silk long underpants by mail order fro

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

a company called L.L. Bean. The silk was smooth and comfortable, the underpants nice and warm.

Then I moved, and moved again, and again. I found myself 20 years

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

ater unpacking boxes of clothing in Singapore. There were the old silk underpants.

They were not much use to me now, living near the equator. And even less attrac

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

Combination pro

ive because they had holes in the knees and were fraying at the ends.

I almost threw them away, then remembered that L.L. Bean features a ‘lifetime guarantee’.

I

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

put the underpants in a plain, brown envelope and inserted a simple handwritten note: ‘Please replace these.’

I didn’t have the company’s full address. I had not

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

rdered clothing from them for years. On the outside of the envelope I wrote: L.L. Bean, Customer Service, Maine, USA.

At the post office I felt foolish mailing ba

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

k such a ragged piece of clothing. It didn’t seem right to send old underpants all the way around the world by airmail. So for a dollar I sent them the slow way, b

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

sea.

Time passed and I forgot all about it. Life quickly filled with new sports, new clothing, and new underpants.

Two months later an envelope arrived from L.L

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

Bean. Inside was a money order for one dollar. No explanation, just a dollar. I figured they evaluated the old clothing and calculated its leftover value! I laugh

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

Following aspects would a

ed and forgot about it.

Another month passed and a bigger envelope arrived. Inside was a brand new pair of silk long underpants. Same size and color as the old on

dd to the challenges in developing combination products:

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

s, but brand new!

In time, new catalogs arrived from L.L. Bean and I bought some new clothes. I always feel safe buying from them. I know from experience their ‘l

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

fetime guarantee’ is real.

Months later I was in the United States and called to place a holiday order for some relatives. Chatting with the L.L. Bean telephone r

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

presentative, I told her the story of returning my old underpants.

‘One thing still confuses me,’ I confessed. ‘What was the one dollar money order for?’

Laughin

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

, she replied, ‘Before replacing your underpants, we refunded your postage!’

Twenty-year-old underpants, gladly replaced, including refund of the postage. That’s

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

Professional from academic institutions, pharmaceutical industries, health care indust

xtraordinary. That’s truly amazing. That is Legendary Service.

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

-----------
Using the words `legendary service' is not enough to make it real. You must expand, imagine, innovate - and take real legendary action.

Act

.

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

on Steps
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A legend is a story people talk about with admiration and prai

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

Companies that provide selfless information through particip

e, recounting some great deed done in the service of others. What great deed can you do for customers that is admirable, praise-worthy and truly unsurpassed?

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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There are several ways to go about writing a small note of appreciation to an interviewer. Try getting a business card from your interviewer. (Nowadays, it seems like everyone has a business card - including my hairdresser!) If you cannot, be sure to remember to write down the name of your interviewer before you go to the interview. Alternatively, attempt to remember his or her name as you introduce yourself at the beginning of the interview. Also, get the address of the establishment you visited. (If it is a branch office of a larger company, strive to use the branch address, NOT the corporate headquarters!)

Dealing with the one sure way to deal with age bias in the employment office. A sure fire suggestion for taking advantage of the changes occurring in the marketplace.

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