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Managing a new and growing business requires a vision far beyond what the average manager can even begin to comprehend or understand. This vision may be the ing

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

redient which separates a leader from a manager.

As the business grows, the top manager or the founder/owners turn control freaks as they believe they need to

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

Examples of combination products may in

urture the business at each step of its infantile existence step lest it falls and fails. They turn perfectionists and involve in every aspect of business belie

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

ving that they are the best and most capable to run the business. This effectively kills emergence of new leadership, throttling the business growth.

Controls

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

re also camouflaged as systems orientation. Too much control spell the death of dynamic decision making and ultimately blunting the competitive edge and operati

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

Combination pro

onal efficiencies. Many of the early successes of the new business and a quick death shortly thereafter are an indicator of too many controls killing the initia

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

ive and creativity.

So the mentor and guide becomes the problem instead of a problem solver.

What should the owner/ceo do to avoid the the control syndrome?

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

Check Your Ego

As the CEO or Owner you believe you know best. You also believe because it is your money at stake you have a higher interest and responsi

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

ility in protecting your own and stakeholder value. Most owners or ceo’s believe people working for them are not as knowledgeable and involved as you are. Even

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

the smallest of mistakes they make are blown out of proportion as an excuse to step in. In fact your managers may know better how to run your organization than

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

ou do.

Business chiefs who cannot let go of the controls often end up stunting their business; Opportunities are lost as too many controls deter any effective

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

Following aspects would a

ecision making and exploitation of dynamic business trends.

Define Your Role

As head of a growing organization you need to define your role and role of

dd to the challenges in developing combination products:

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

all your managers. The owner/ceo needs to help others to be productive and manage better rather than to manage on their own. Once you see how effective your ma

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

agers are, you could cut back on your involvement in micro management and focus on the broader aspects of growth and development.

Take it Step by Step

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

Once you decide to be less meddlesome, plan on how you are going to reduce your involvement day by day. This will enable your managers to appreciate your intent

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

ons and respond to increased responsibility more positively. It would also help them to find their own footing and get accustomed to taking major decisions.

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

Professional from academic institutions, pharmaceutical industries, health care indust

>Trust Your Managers

Trust and empowerment is the surest way to nurture talent. When the manager knows that you trust them to deliver, they would go that e

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

tra mile to keep the trust you have reposed on them.

Finally the leader has to realize that unless more leaders are created one cannot grow. You can do only s

.

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

o uch and if you want more you need people who can duplicate your own success. All business growth depends on a vision of creating value for as large a group –

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

Companies that provide selfless information through particip

include customers, employees, shareholders, promoters, partners, vendors – as possible if you really want to build an organization that would be a future legacy

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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