Digg It - Business

“Winning athletes need to plan their training routine; train under the conditions that will be similar to the actual event; control their di

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

et; set targets to be achieved; monitor progress and performance; constantly refine elements of their regime; and most importantly they must

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

Examples of combination products may in

motivate themselves towards achieving the ultimate goal – Winning!

So what is so different about business? A business needs…”

This was th

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

e start of an article I wrote some years ago and clich? apart this analogy is still as relevant, if not more, than it was then.

A business

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

needs to ensure that everybody has been trained to carry out their duties, to know what impact they have on the total process internally and

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

Combination pro

most importantly the customer; and be able to adapt to ever changing conditions by having readily available information about their company

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

, their customers, the competition etc.

As with a successful athlete there is a certain percentage of talent involved. Not just anyone can

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

be a gold medal winning sprinter, but only in the right environment and regime will that talent flourish. The same applies to the personnel

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

that make up a business. You hire talented and dedicated sales people and with the right training regime their talents are honed and refined

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

.

However, that is where the analogy ends, there is one caveat and it can be summed up in one word; TECHNOLOGY.

Today’s businesses see tec

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

hnology as a huge performance enhancement to their organisations, so much so, that the technology they use is purchased with the assumption

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

Following aspects would a

that it will solve most if not all problems. This is like the athlete expecting that by wearing the latest scientifically engineered trainer

dd to the challenges in developing combination products:

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

s he is guaranteed to win a race. In the athlete’s world, the calibre of a training facility is there to aid the existing talent and trainin

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

g regimes. The mistake that most businesses make is expecting technology to exceed this mandate and deliver results that are not there.

Tec

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

hnology in the business environment is the means to create an optimised environment so that the sales personnel can be ready at all times. I

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

n the same way a football teams play friendly matches to get match fit and test their tactics and game plans, business technology offers a s

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

Professional from academic institutions, pharmaceutical industries, health care indust

ales team the chance to know their own match readiness. The mistake that today’s businesses make is that too often the glitz, glamour and th

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

e interactivity of a technology solution flatters to suggest that it will offer more than this. The bottom line is, that without the foundat

.

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

ions of a well understood sales process that is in use by talented sales people, your new technology is not going to work, worse still if by

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

Companies that provide selfless information through particip

implementing a technology your sales processes have to change to adapt to the system, then your business is almost always likely to suffer.

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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