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Sport is often used as a metaphor in business, comparing the effort of the team with that of the organization. The goal of such a comparison is to improv

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

e your business (process) from what you observe and learn from sports, in this case soccer.

There are two relevant questions. First, “what team will per

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

Examples of combination products may in

orm best?” And, “will the best team win?” But to focus on the comparison, you should focus on the second question only, because the first is basically ab

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

out quality which is difficult to measure. So; what will make a team win the games? There are several factors – all present in either area:

Fact

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

r one – Luck. Ordinary luck, we are not able to influence everything, you need some kind of luck to win ... Like "the hand of God" (Maradona)?

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

Combination pro

Factor two – Environmental influences (Back luck): A “wrong” decision of a referee falls in this category. Also, your starting position in the group may

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 more of a challenge than for other teams. This seems even more true in business where circumstances are never really equal.

Factor three – In

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

dividual talent and specialists. The football player is a world (global) profession. Players all over the world are exchanged and transferred, which make

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

that technical differences between countries are assimilated. Technical talent becomes less of a differentiator. Same as in business, professionals are

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

available especially in highly specialist environments (law, medicine, engineering, etc). It is less true in those businesses where the profile of a prof

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

ssional is harder to define.

Factor four – Teamwork. Teamwork is more and more of a differentiator, both in business as in sports. Although it

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

Following aspects would a

s difficult to examine what teamwork is, you can tell when observing a game: the player that passes the ball to someone who freed himself from his oppone

dd to the challenges in developing combination products:

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

nt; ready to score. The most difficult factor to manage, both in business but especially when you have a team of (individual) top talent.

Facto

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

five – coaching, training and preparations. Being prepared! This involves all the strategy behind the game. Observing the opponents, preparing the tacti

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

cs... The role of the coach should be underestimated; It is all to do with time to market., You have got only a limited time to prepare and you cannot sw

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

tch direction in the middle. Right to the point to constitute a winning team. In business this is done by searching for new challenges. Try to increase t

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

Professional from academic institutions, pharmaceutical industries, health care indust

he targets up to a level that they are still credible.

Factor six – gear. In sport this is hardly an issue. Top players use top gear. In busine

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

s this is different. Investing in gear like systems, infrastructure and working methods, etc. is where a company will make the difference.

Fac

.

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

tor seven – Threshold or entrance level. In order to excel in any area, you first need to enter the league. You must reach the threshold of all those fac

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

Companies that provide selfless information through particip

ors that are basic. These cover technique, teamwork, training, stamina, coaching and all other competences that are required.

© 2006 Hans Boo

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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For those looking for career advice to find the best freelance writing jobs available, they will find a few things here that will help them.

All too often, we are guilty of forcing our cashiers to follow a series of service steps in an effort to standardize our delivery system. To that end, we simply process people through a line. As guests, if we wanted that, we could simply have a terminal where we enter our own order. That idea would be as successful as the failed full-serve restaurants where you had to cook your own steak!

When we agree to an idea or proposal, it’s because there's something in it for us. It's hard to influence people who can’t see what's in it for them. Sounds one-sided, but it is true. Call it self-interest, selfishness or whatever. It is only human nature to ask, 'What am I getting from this?'

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