Advice You - Business

What an Idea! It was in the 1980s, when I owned a manufacturers representative sales agency that I heard Patricia Fripp talking about this idea in one of her success seminars. I tried the idea with my sales team and it worked magnificently

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

. For over a decade now, I too have been sharing this tool with audiences across North America and have received numerous notes of success from attendees.

Let me first warn you—while this tool is simple to understand and quite easy to use

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

Examples of combination products may in

, if executed incorrectly, can be crushing to your ego. But, what the hay—as a leader, it is your job to leave your ego at the door when you come to work each day.

The Value

The important value you will receive from this tool is that 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.

nowing what perceptions your employees hold about you and their work environment. I absolutely believe that in every company—no matter how caring toward employees—exists a metaphorical two-story outhouse. Since we all know what flows downh

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

ill, your concern needs to be that of determining how to dismantle or tear down this barrier between you and your employees, no matter how inconsequential you believe it to be. Learning the perceptions of your employees is key to bettering

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

Combination pro

the work environment for them. It is also true for creating an open door safety net that will allow employees to operate in an environment that encourages them point out overlooked mistakes before they become costly catastrophes.

The Too

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

The brief description of this tool is to sit down with your key employees, department heads or executive team—one at a time—and ask them to share with you three things that they do not like about how you manage them and the organization.

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

Then to ask them to share with you three things they do like.

A Word of Caution

In order for you to successfully use this tool you need to realize that your employees will be very skeptical at first. They will wonder what’s gotten into

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

you—what’s your true motivation in asking these questions? Also, you must be aware of the fact that they will “feel the water before jumping in” meaning that they will test you first before they will share their true perceptions. With this

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

being stated, be cautious to only thank them for their answers rather than to question or challenge their answers in a knee-jerk fashion. If you do not understand what they are saying, it is okay to ask for clarification but any comment ot

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

her than a “Thank you” will greatly diminish your employees’ willingness to take a risk and tell you the truth.

Tool Implementation

Select the employee with whom you believe you have the best relationship for your first go at the Three o

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

Following aspects would a

n Three. Do this because you will be the most at ease with this person. After your first success, each consecutive session gets easier to conduct.

1. Find a neutral location (your office is unacceptable) and sit them down in a relaxed atm

dd to the challenges in developing combination products:

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

sphere.
2. Tell your employee that you have a desire to improve your management style and the work environment for all the employees.
3. Ask them for their help in honestly answering some questions.
4. Insure them that no

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

thing they say will ever be held against them in the future.
5. Now ask them to share three things with you that they don’t like about your management style or the work environment. Remember, the first answer is testing the water so

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

even if you feel like you’ve just been stabbed in the heart, you must only reply with, “Thank you.”
6. Repeat step #5 two more times. Generally, the second or perhaps third response is where you hit gold and get some real feedback. <

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

r> 7. In a sincere manner, tell them that you will work on what they said and that you will get back to them in a week or two to discuss what you have done about the items they shared.
8. Now you can ask for three things they do lik

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

Professional from academic institutions, pharmaceutical industries, health care indust

e about your management style and the work environment. Again, only respond with, “Thank you.” This is not the time to puff up your chest and talk about your greatness.
9. After the third positive response assure them that you are go

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

ing to try to do more of those things in the future.
10. The master key to this whole process is that you MUST get back with this employee in the week or two that you promised and have completed some definitive action toward improvem

.

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

nt on at least one of the items they shared with you as being a problem—an action toward all three issues is optimal.

Do this Three on Three process with your key people at least twice a year—quarterly is better—and at this time next year

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

Companies that provide selfless information through particip

, I guarantee that you will have noticed results.

To access helpful additional information from Ed Rigsbee at no charge, please visit www.rigsbee.com/downloadaccess.htm

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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There are several firms in New Jersey that provide bookkeeping services to businesses who are not able to deal with the additional work of bookkeeping. Hiring a professional from outside can be beneficial for your business in several ways.

What was the recipe for success that global companies used to get where they are today? When you go and buy a product that is globally known, do you ever stop to think that the company was once a small business operated by someone looking to make a difference, like you?

Absence it is said makes the heart grow fonder. But, when an employee absents himself or herself this is definitely not going to be the case. Absence of employees causes the loss of millions of dollars to the economy. Millions of work days are also lost as a result of employee absence. Absence is genuine in two third of the cases while the others just do it for non-genuine reasons.

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