Advice You - Business

In quality manufacturing, speed requires standardization. No wonder Six Sigma, Zero Defects and ISO Certification receive so much time and attention.

But

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

in quality service, doing something unusual or eccentric can create a powerful impact. In service, it can be quite acceptable to find and do your own thing

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

Examples of combination products may in

Here are just a few examples:

A waiter at the Sugar Beach Resort in Mauritius comes to work each day with a thermometer in his pocket. On the way to the

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

restaurant he takes the temperature of the ocean water and the swimming pool. As he pours coffee and clears plates during breakfast, he joyfully tells gues

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

s exactly how warm and enjoyable their swimming will be that day.

A room service attendant at the same resort noticed a guest from Germany reading Goethe

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

Combination pro

uring her stay. He got coaching from a colleague and learned a poem in German by heart. A few days later as he served her dinner in her room, he recited 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 poem proudly for her enjoyment.

A sales clerk at Nordstrom in the United States sold my friend a new pair of shoes. Measuring his feet, the clerk discov

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

red my friend’s right foot was size 9.5 and the left foot was a smaller 9.0. The clerk gave my friend the shoes he needed to achieve a perfect fit: one 9.5

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

and the other 9.0. I have no idea what the clerk did with the remaining mismatched shoes, but my friend’s loyalty to Nordstrom has been secured.

The custo

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

er of a furniture maker in Malaysia returned one large item and selected another. A partial refund was due, but the customer was to leave the country that

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

ery night. One staff member offered to process the refund paperwork on the same day. At 8:15 pm he arrived at the customer’s house with the refund check in

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

Following aspects would a

hand...and a small cake with ‘Bon Voyage!’ written across the top.

At the Raffles Hotel, one laundry worker writes small notes complimenting male guests

dd to the challenges in developing combination products:

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

n the fine fabric of their suits and female guests on the elegance of their evening gowns. These notes are pinned gently to the garments before they are hu

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

g back in guests’ closets after drycleaning. What a memorable moment!

At the Four Seasons Hotel, order a juice or soft drink from the bar. You’ll discover

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

ice cubes made from the same drink. As the ice melts your drink gets colder, but not diluted. You get a stronger drink. Strong service, too.

Key Lea

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

ning Point
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What is ‘your thing’? Is it the personal note you at

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

Professional from academic institutions, pharmaceutical industries, health care indust

tach to outgoing documents? Is it the enthusiastic tone in your voice on the phone? Is it your pride in teaching customers or colleagues something new? Is

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

t as simple as the colorful clothes you wear, the magazine and newspaper articles you share with others, or your passion for indoor plants that makes the w

.

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

ole office come alive?

Action Steps
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Whatever it is that

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

Companies that provide selfless information through particip

urns you on, find and do your own thing. Then take it one step further. Turn ‘your thing’ into something special – to the advantage and enjoyment of others

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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Would you ask an unsuccessful person how to become more successful? Or ask a friend with a run-down car what the best vehicle is on the market? I would think not.

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