Advice You - Business

In the first and second chapters of the book of Numbers in the Old Testament, we find a detailed description of the Israelite campsite during their wilderness trek. To the casual reader an outline of the

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

particulars of encampment might seem to be irrelevant minutiae. What is actually presented, however, is a brilliant model for effectively managing the activities of a large organization. Moses and Aaron

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

Examples of combination products may in

were responsible for governing almost a million people. By adhering to a carefully structured plan for day-to-day concerns they were able to prepare for long term problems and issues more efficiently.

Of

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

course, what was true for the ancient Israelites is also true today. Planning is the key for any manager who wishes to build a company that has a solid foundation for future growth and development. Yet,

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

less than 15% of managers surveyed feel that they are doing an adequate job of planning for the future. In fact, managers rarely fall short of their real potential for lack of technical competence. Of al

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

Combination pro

l the organizations and businesses I have consulted, the one principle cause for failure is the inability or unwillingness of the executive staff to logically and consistently plan for the allocation of li

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

ited resources - labor, money and time - toward all the viable opportunities that exist.

While strategic planning is an integral part of maintaining the growth cycle of a large corporation it is even more

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

critical to smaller organizations because they, typically, lack the resources necessary to absorb the cost of mistakes, errors in judgement, or failure to foresee change. The planning process allows mana

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

gement to evaluate the future where they want to be and how to get there. It helps them establish goals and then gives them a performance standard by which to measure themselves. Better yet, planning al

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

ows them a process to identify and resolve problems before they become crises.

Before gathering your staff together - either formally or informally - to begin the planning process for the future growth an

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

d development of your company, it's important to understand exactly what this vital activity will accomplish:

1. Planning formulates the future. The planning process allows the people in your organizatio

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

Following aspects would a

n to anticipate and, therefore, shape the future.

2. Planning motivates people. Everyone wants to have a part in determining their future. The greater the feeling of ownership each individual has in det

dd to the challenges in developing combination products:

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

rmining the objectives of the organization, the more committed they will be to making sure those objectives will be achieved.

3. Planning establishes the organizational structure of a company. The planni

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

ng process will clarify what structural issues need to be resolved in a company. This will determine what organizational model needs to be implemented to address these issues.

4. Planning directs delegat

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

ion. The key to effective delegation is understanding the assets and liabilities a company has in terms of its human resources. By determining who is best suited to handle a particular role, the entire o

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

ganization should be able to live up to its maximum potential.

5. Planning promotes communications. The planning process affects each division of a company, including the finance, marketing, sales and op

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

Professional from academic institutions, pharmaceutical industries, health care indust

erations divisions. Thus, for each area of a company to achieve their respective goals, they must cooperate and communicate with divisions that they normally don't communicate with.

6. Planning fosters t

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

he process of monitoring. The planning process establishes standards or goals that an organization must achieve to accomplish their overall objectives. Without a monitoring system, management will not be

.

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

able to assess how well these goals are being achieved.

Planning is essential for the survival of the company. If the organization does not have the time or manpower to do adequate planning, then the com

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

Companies that provide selfless information through particip

pany should utilize outside resources to help them set, monitor and achieve their goals. Time spent on planning is time well spent and money spent on planning is money well spent when the plan is utilized

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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