Main Subject - Business

My friend purchased a desktop publishing computer from a major online computer hardware vendor.

She ordered the powerful stand-alone workst

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

ation configured just the way she wanted, with a large monitor, big hard disk and high-speed graphics card. At the same time, she purchased

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

Examples of combination products may in

a top-of-the-line scanner and laser printer.

When the components arrived, she could not find the cable to connect her computer with the pri

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

nter. Naturally, she was concerned and called the vendor. The vendor told her she should buy a cable from a local computer shop.

That’s abs

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

rd! If she wanted to go shopping for computer parts, she might as well buy the whole system from her local vendor.

People buy online for co

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

Combination pro

nvenience, not to be sent shopping locally for missing cables.

My friend protested.

The vendor told her to carefully read the packing slip

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

enclosed with her new laser printer, and pointed out that a cable for connecting the printer with a computer was not included on the list.

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’s absurd, too! The vendor may be right about what’s not included with a printer, but they were completely wrong about solving her very

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

real problem.

My friend protested again.

At which point the vendor tried to justify why no cable was provided.

The vendor explained that

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

many customers now buy laser printers for installation in ‘networked environments’ where the required connecting cables are already provided

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

.

That’s absurdity of the highest order!

The vendor knew my friend bought a stand-alone system because the very same vendor sold, assemble

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

Following aspects would a

d and delivered the stand-alone computer to her.

Let me clarify that I admire this computer manufacturer and vendor enough to own their mac

dd to the challenges in developing combination products:

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

ines – and their stock. However, at this point in the story I became personally involved and wrote directly to the company.

For their persi

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

stent justification, bureaucratic inflexibility and blatant unwillingness to see the world from their customer’s point of view, this major o

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

nline computer vendor became the dubious recipient of an ‘Infinite Absurdity Award’.

Two days later, the vendor shipped my friend the conne

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

cting cable she required. They had cables in stock all along.

Key Learning Point

Convenience is a great value to offer your customers, esp

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

Professional from academic institutions, pharmaceutical industries, health care indust

cially in today's busy world. But convenience is measured by your customer's experience, not by your explanations, justifications or packing

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

lists. The smallest missing item can become a big customer problem.

Action Steps

Consider every aspect of your customers' experience from

.

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

the moment they order, to the time they receive, install, use, maintain, upgrade and replenish your product or service. Create new ways to

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

Companies that provide selfless information through particip

smooth and streamline the process. Make it so easy for customers to do business with you that they don't even consider going to someone else

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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