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According to Rob Sheehan, director of executive education at the James MacGregor Burns Academy of Leadership at the University of Maryland, “Being a good boss is important in any organization, but it’s particularly

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

important for small business. With smaller businesses, you really have the opportunity to set the tone for the entire company.” There are several characteristics, traits, and attitudes that seem to be prevalent

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

Examples of combination products may in

among executives that are viewed as “good bosses” by their employees. These include:

• Including all levels of employees in decision making

• Concentrating on the company’s mission, not just its ability to make

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

oney

• Demonstrating the value of learning new skills

• Encouraging employees to advance their careers

• Setting an example of a positive attitude and work ethic

Assigning Responsibilities

The organizat

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

ion of your small business will be determined by your determination of who should be doing what and when – in other words, assigning tasks and duties to your employees. At the center of any organization are its pe

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

Combination pro

ple and those people have to know what is expected of them in order to perform satisfactorily. Usually a small business will start with a few (maybe even one) person(s) performing all of the day-to-day functions.

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

However, as the business grows it will be necessary to hire others to perform specific roles within the firm. As a manager, you will be required to recognize when new needs emerge and to hire the appropriate pers

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

onnel to address those needs.

Business Teams

You should not be the only one responsible for the success of your small business. The ultimate in organization is the formation of a business team that allows

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

you to delegate authority and, as a result, increase productivity. Your business team should consist of those employees who are in charge of the major functions of your organization. To be effective, a business

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

team must have a leader that is respected by all of the team members. In return, the leader must respect all of the member’s individual abilities. A team spirit should be evident as each member uses his or her s

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

rengths to compensate for the weaknesses of others. Mistakes in the workplace should result in correction not retribution. Each member of a team should realize their own importance to the organization and feel

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

Following aspects would a

free to explore other areas of activity.

Communication

Tips for Employers

A 2001 study analyzing 20,000 exit interviews revealed that the most common reason that people leave a job situation is poo

dd to the challenges in developing combination products:

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

r supervision – basically, they had a bad boss. Probably the biggest factor contributing to the perception of poor leadership seemed to be poor communication skills. How can you as an employer improve your commun

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

cation with your employees? Try out a few of the following suggestions:

1) Listen. Actually pay attention to what your employees are saying. As simple as this sounds, try this exercise; Tape a conversation then

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

after you have finished communicating, try typing as much as you can of what the other person said. When you are finished, play the tape while reading your notes. See how accurate you’re listening and memory is.

2

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

Designate specific times to meet with your employees one-on-one at least twice a month. Not allowing interruptions during these meetings will convey to them that they have your undivided attention and that you va

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

Professional from academic institutions, pharmaceutical industries, health care indust

lue their input.

3) When changes are going to have to be made in the workplace, let those affected know as soon as possible. Tell them personally and don’t let them find out through the grapevine.

4) Let your em

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

ployees know what you stand for. When they are aware of your value system, they will be able to make better decisions, or at least decisions that will be more pleasing to you.

5) Let your employees know how they

.

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

re doing on a regular basis. Don’t let an employee find out that they are not performing up to your standards at their yearly performance review.

6) Improve your public speaking skills. Your credibility with you

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

Companies that provide selfless information through particip

r employees is directly tied to your ability to convey information to them successfully.

7) Don’t use e-mail to do your dirty work. Whenever a situation involves strong emotions, it should be dealt with in person

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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The customer is the lifeblood of any business, and it is only right that business owners and managers provide optimum customer support through the quickest and most accessible medium – the telephone.

Knowledge is an an aggregate of knowledge systems, including indigenous or community (local or traditional) knowledge systems as well as scientific (formal ways of knowing) knowledge systems. The purpose of this article is to provide baseline information on how community lay knowledge systems can be applied in development approaches in coalition with scientific knowledge systems. In coalition the knowledge systems can provide further impetus to understanding and finding innovative solutions for practical problems experienced.

Getting people to support a cause may be easy but getting them to support it with money is another thing! People may feel sympathetic with the project and may even identify with the problem that you are aiming to solve but they may not go to the extent of supporting it with money.

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