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So there I was sitting in my underwear, waiting for my doctor with whom I had an appointment for my an

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

nual physical examination. I had arrived on time and was ushered into the examination room about ten

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

Examples of combination products may in

inutes later. After my blood pressure was taken I was told to undress and wait for the doctor.

I wai

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

ted for over half-an-hour and became cold sitting there almost naked so I put some clothes on, figurin

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

that, if I had waited this long for the doctor, he could wait a minute for me while I undressed again

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

Combination pro

when he arrived. Another fifteen minutes slowly went by. I realized that I could no longer be examin

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

ed and make an important appointment I had scheduled so I decided to leave.

I explained to the recept

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

onist why I was leaving. She responded with, “I’m sorry, but we have no control if the Doctor is dela

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

yed at the hospital.” I said I understood, maybe he was saving someone’s life or delivering a baby.

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

ertainly there are many medical procedures more crucial than my physical exam. But what I can’t under

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

tand is the complete lack of communications and patient relations (or from my perspective – customer s

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

Following aspects would a

ervice).

If the doctor was involved in a life-saving procedure or just having coffee with his buddies

dd to the challenges in developing combination products:

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

someone in the office should be tasked with the responsibility of remembering that there are patients

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

waiting for him who should be informed of the delay rather than wondering, getting cold in their unde

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

wear, and quietly fuming.

Good customer service (or patient relations) is just the simple matter of t

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

eating people in a respectful, helpful manner. When a vendor can’t deliver the product or service whe

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

Professional from academic institutions, pharmaceutical industries, health care indust

n it is expected, the vendor should respect the client / patient / customer enough to announce the del

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

y and allow them to adjust their plans, not sit fuming in their underwear. Loyalty is built on a foun

.

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

dation of respect. Understanding this along with a simple communications system (“The Doctor is runni

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

Companies that provide selfless information through particip

g late at the hospital, I’ll let you know when he will be arriving”) would have defused this situation

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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During the last eighteen months I have carried out several investigations relating to good governance, compliance and fraud. My work has highlighted how easy it is for public and voluntary bodies to become complacent ‘because they think they have the necessary safeguards and systems in place’.

Don't you just hate job interviews? Or perhaps you don't! I know I do. Well, it's not so, much the interview itself as the fear of the unknown questions they have prepared. I bought a book once on how to answer job interview questions and although it was a useful confidence booster, it did little to improve my chances of getting job offers.

If you want to know more about innovation, it is sometimes useful to observe other organizations. To dig into the world of those organizations that are quite the opposite of innovation and learn more about those forces that are required to conserve. And not without a reason...

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