Main Subject - Business

I recently upgraded the telephone system in our home and office. For the next two d

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

ays everything about the phones went wrong: crossed lines, disconnected calls, non-

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

Examples of combination products may in

working outlets, strange buzzing sounds.

Only after two additional visits by the t

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

echnician was the upgrade working as intended.

Have you noticed how often this hap

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

pens?

The new improved computer software runs slower than the version you just rep

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

Combination pro

aced. The latest hardware proves harder to manage than the system you abandoned. 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 new car goes back to the shop for an adjustment within two weeks when the old car

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

worked perfectly for years. The new home has a door that jams, a roof that leaks,

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

a window or floorboard that squeaks.

No one intends an ‘upgrade’ to start out as a

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

‘downgrade’, but the pattern is familiar and occurs frequently.

Key Learnin

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

Point
----------------------------------------------------------------------

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

Following aspects would a

----------
Be upfront with your customers about glitches or hiccups that may o

dd to the challenges in developing combination products:

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

ccur - and be ready to provide help and reassurance through the early stages of imp

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

lementation.

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

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

------------------------------------
If you are upgrading or changing your ser

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

ice in ways that affect your customers, send them advance warning and acknowledge o

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

Professional from academic institutions, pharmaceutical industries, health care indust

penly what everyone already knows: things go wrong, upgrades take time, it takes ef

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

fort to locate and iron out the wrinkles.

Be positive and proactive about problems

.

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

that may occur. Use honesty to build a bond of truth and a commitment to construct

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

Companies that provide selfless information through particip

ive collaboration.

And, if you are the customer, be prepared to hurdle the hiccups

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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