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PLAY BALL! Baseball season has begun. All winter, teams have been making deals to acquire the best possible talent. However, star power

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

alone doesn’t win a championship. As Babe Ruth said, “The way a team plays as a whole determines its success. You may have the greatest

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

Examples of combination products may in

unch of individual stars in the world, but if they don't play together, the club won't be worth a dime.” Therefore, smart teams have spe

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

t spring training working on creating a team culture, developing team dynamics and molding their group of stars into a cohesive unit who

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

will work together to win a championship this year.

I had the privilege to hear Red Sox skipper Terry Francona speak about the 2004 ch

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

Combination pro

mpionship Red Sox. He talked about how their historic and odds defying wins were as much about team chemistry and off the field team bon

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

as it was about on the field talent and heroics.

Companies can learn from this. When building their team, they need to examine how the

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

talent they hire fits the culture they wish to build. It is hard to change individuals because most people don’t want to critically loo

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

at themselves and they hate change. Therefore, instead of just hiring for talent, companies must examine candidates for attitude and te

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

m fit.

The entire team must be on the same page and working as a unit. An organization will fail if people are acting as individuals an

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

in their own best interest, just like a baseball team may lose if the hitter tries to boost his batting average rather than hit a sacri

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

Following aspects would a

fice and move the runner closer to home plate. When everyone is aligned, the organization is aligned and heading in the same direction.

dd to the challenges in developing combination products:

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

Traditional business thinking aims to control situations, but companies must avoid the temptation to try to set the culture by force. Co

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

panies should stop focusing on controlling employee interactions and focus on matching up people with similar expectations who will buil

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

d and deliver the desired culture. When you recruit based on shared expectations, less effort will be required to attain success. This 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

due to the fact that the team will shape their own culture based on these expectations and they will be inspired to advocate for the or

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

Professional from academic institutions, pharmaceutical industries, health care indust

anization. Because of this, companies will find it easier to recruit and retain other loyal internal and external advocates.

If you wan

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

t to win, hire for attitude and team fit, create an environment where extraordinary things can happen, give your team the power to shape

.

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

the organization, the resources to get it done, and the guidance to keep it moving forward. If you follow these steps, your team will cr

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

Companies that provide selfless information through particip

ate an extraordinary culture that builds long-term advocacy, the organization will succeed, and you will have a strong and winning brand

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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Do you have any idea what role color plays in your marketing efforts? And if so, do you know what message your marketing efforts are conveying with the colors you use? Let me tell you that the colors you use in your marketing efforts - your brochures, business cards, letterhead, signage, office interiors, and more - play a very important role in motivating people. The colors speak loudly and clearly, so I believe it is in our best interest to learn what the colors convey in our marketing.

Why is it that so many companies are running into deep trouble despite the measures taken? And why when in trouble these companies are repeating over and over again the same procedures, which in the end didn’t save them? Why would someone expect a different result when repeating the same approach?

Advertising is not magic. It is an investment. A business must get an acceptable ROI. To do so, requires measurement, patience, and committment. Substantial penalty for early withdrawl...

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