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Senior executives who rise to the C-suite do so largely based upon their ability to consistently make sound decisions. However while it

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

may take years of solid decision making to reach the boardroom it often times only takes one bad decision to fall from the ivory tower.

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

Examples of combination products may in

The reality is that in today’s competitive business world an executive is only as good as his/her last decision.

Nobody is immune to ba

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 decisioning…We have all made bad decisions whether we like to admit it or not. I have either been a principal owner or senior executi

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

ve since I was in my mid 20’s and have generally been highly regarded for my decision making ability. That being said, I have also made

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

Combination pro

my fair share of regrettable decisions. When I reflect back upon the poor decisions I’ve made it’s not that I wasn’t capable of making t

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

he correct decision, but for whatever reason I failed to use sound decisioning methodology.

The complexity of the current business land

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

scape combined with ever increasing expectations of performance and the speed at which decisions must be made are a potential recipe for

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

disaster for today’s executive unless a defined methodology for decisioning is put into place. If you incorporate the following metrics

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

into your decisioning framework you will minimize the chances of making a bad decision:

1. Perform a Situation Analysis: What is motiv

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

ating the need for a decision? Who will the decision impact? What data, analytics, research or supporting information do you have to val

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

Following aspects would a

idate your decision?

2. Subject your Decision to Public Scrutiny: There are no private decisions…Sooner or later the details surroundin

dd to the challenges in developing combination products:

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

g any decision will likely come out. If your decision were printed on the front page of the newspaper how would you feel? What would you

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

r family think of your decision? How would your shareholders and employees feel about your decision? Have you sought counsel and/or feed

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

back before making your decision?

3. Conduct a Cost/Benefit Analysis: Do the potential benefits derived from the decision justify the e

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

xpected costs? What if the costs exceed projections and the benefits fall short of projections?

4. Assess the Risk/Reward Ratio: What a

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

Professional from academic institutions, pharmaceutical industries, health care indust

re all the possible rewards and when contrasted with all the potential risks and are the odds in your favor or against you?

Decisions c

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

an, and usually will, make or break an executive. Those executives that avoid making decisions for fear of making a bad decision will ra

.

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

rely rise above mid-management, and those that make decisions just for the sake of making a decision will likely not last long. If you

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

Companies that provide selfless information through particip

develop the appropriate blend of a bias to action with an analytical approach to decisioning your stock as an executive will surely rise

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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In this article I have some suggestions for those of you thinking of starting a new brochure or revising an old one.

When you use a resume, you should use one that specifically targets the job you are applying for. That may mean revising it multiple times, or creating a totally new one. But it also may mean that you get the job because you used a more effective and appropriate resume. For example...

To get a new job, you need to choose a career path and act upon it. Create a career builder strategy and make constant benchmarks to compare your progress.

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