Advice You - Business

“It is not the strongest of the species that survive, not the most intelligent, but the ones most responsive t

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

o change" - Charles Darwin

Whatever got you where you are today will not be sufficient to keep you there. A

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

Examples of combination products may in

apidly changing environment is the regular background against which organisations must develop.

Change is contin

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

ous and will become more rapid as we move forward over time. Senior management must be capable of reacting to tho

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

e changes and be prepared to take advantage of them and yet stay within the overall framework and agreed strategy

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

Combination pro

The role of strategy is fundamental if the people within an organisation are to be enabled to make the level of

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

contribution of which they are capable. Strategy, based on a good grasp of the core competencies of a business, i

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

s an essential precursor to achieving optimal shareholder value.

Dependence on salespeople is key to delivering

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

he latent capability of a business. Our salespeople are the greatest source of competitive advantage we have and

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

hat is precisely why we should continue to invest in them and fully develop them. This is particularly true now t

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

at in most market sectors competitive advantage is continually being eroded – i.e. International barriers are com

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

Following aspects would a

ng down, selling time is becoming limited, competitors are getting smarter, fewer and fewer names are appearing o

dd to the challenges in developing combination products:

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

companies’ databases, and product uniqueness is rare. Conversely, undeveloped personnel can bring down a company

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

through inadequate performance, leaving the competition to harvest the marketplace.

If your organisation wants t

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

o permanently increase it’s sales results then it needs to approach sales differently to create “the difference 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

at makes the difference” in order to positively impact bottom line performance.

In Summary: Organisation

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

Professional from academic institutions, pharmaceutical industries, health care indust

and salespeople who have 100% commitment to doing whatever it takes to elevate their sales to a whole new level

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

re the ones most likely to succeed. Trying to operate a sales organisation without total commitment is like tryin

.

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

to drive a car without fuel. But every organisation has the potential to harness the power of their salespeople

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

Companies that provide selfless information through particip

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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