Main Subject - Business

My friend Nancy was learning about her international callback service and exchanged e-mail with their office in Seattle.

She still had unanswe

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

red questions and e-mailed them once again.

The same person responded, suggesting that Nancy read the material they had sent. But Nancy had no

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

Examples of combination products may in

received any materials, so there was nothing to read or study.

Once again, Nancy e-mailed her questions to Seattle. This time she got an abru

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

pt reply: ‘If you would read the material, you wouldn’t have to keep bothering me.’

Nancy shot back, ‘I never received the material. And whate

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

er happened to customer service?’

The response from Seattle? ‘I’m not in Customer Service. I’m in Sales.’

This episode illustrates one of the

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

Combination pro

great challenges in business: how to get everyone thinking, speaking and acting as a coherent organization, presenting ‘one shared voice’ to t

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 customer.

The challenge is inherent in the nature of specialized companies today. Precise engineers are hired for different tasks and purpos

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

es than the extroverts whooping it up in Sales. Detailed accountants are trained much differently than the expansive minds in Marketing and Com

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

unications. People in Production are measured differently from the team in After-Sales Service.

So what can you do to build an organizational

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

culture where people understand one another and everyone works together? How can you build your team so the folks in Sales realize they are als

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

in Customer Service?

Here’s one set of proven and effective ideas. Try them!

• Use cross-functional teams to tackle persistent issues and or

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

Following aspects would a

anizational problems.

• Involve people throughout the company in joint training programs.

• Schedule time for frequent rotation and attachmen

dd to the challenges in developing combination products:

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

t of staff between various departments.

• Send cross-functional groups on ‘mystery shopping’ tours to competitive organizations.

• Get every

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

epartment involved in focus group meetings to study customer compliments and complaints.

• Create a recognition program to praise cross-functi

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

onal communication and improvements.

• Implement a reward scheme for everyone based upon overall company performance.

• Communicate customer

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

ssues to every person in every department through meetings, newsletters, e-mail, intranet and bulletin boards.

Key Learning Point

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

Professional from academic institutions, pharmaceutical industries, health care indust

--------------------------------------------------------------------------------

In the hustle of day-to-day business, many people f

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

cus largely on the job at hand. This narrow view may help them ‘get their job done’, but may also blind them to shared customer and company con

.

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

cerns.

Action Steps
--------------------------------------------------------------------------------

Implement activiti

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

Companies that provide selfless information through particip

s that encourage cross-functional sharing, caring and interdependence. Insist upon ‘one shared voice’ that understands and serves your customer

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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