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Small businesses may think that business continuity is just for the big boys. 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

let’s consider the following small business advantages;

1 Sharper perspe

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

Examples of combination products may in

ctive

When something goes wrong in big business people always say -
“when d

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

d this start happening?”
“which department was involved?”
“why on earth was I n

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

ot told?”

When something goes wrong in a small business - you know.

2 Quicker re

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

Combination pro

ctions

“ICEBERG!”

Captain of tanker –“Emergency, prepare for evacuation!”

Capt

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

ain of yacht –“Get your cameras out!”

3 Lower profile

When big business

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

makes a mistake – the newspapers, the TV and the internet make sure we all get to know abo

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

ut it.

Small business problems rarely get a mention.

4 Simplicity

Big

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

usiness – imagine a house of cards

Small business – a few building blocks

5 Gett

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

ing help

Big business - “If I ask for help (mutual aid) I will look weak.”

Smal

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

Following aspects would a

l business - “If I ask for help I will look more professional.”

6 Less opinions
dd to the challenges in developing combination products:

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

Big business – “I must try to please all of the people all of the time - sharehold
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ers, investors, regulators..”

Small business - “I do what I want, when I want.”

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

Big business – “Let’s test the continuity plan. Hire the consult
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
ants, prepare a press release, ask finance if when we can afford it.”

Small business – “I
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
’s a quiet Tuesday in January. Shall we test the continuity plan?”

8 Spreading th
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
e supply chain risk

Big business - “We’ll have 10,000 from 1 of you.”

Small bus
.

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
ness – “We’ll just have 10 from 3 of you.”

Of course we all face many risks in business t
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
oday but whether you are big or small, just ensure your business continuity plan is strong

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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Digg It - Can Small Be Beautiful In Business Continuity?

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