Main Subject - Business

THE EYE OPENER

Change is the word used to describe the transition that occurs from same to different. This transition can effect different things in different ways. If you move a house plant from one location

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

to another the plant may get plant shock. When seasons change from summer to fall many people will become ill with the flu. Moving ones place of residents is described as the most radical of changes in a pers

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

Examples of combination products may in

ns life. Another change is the inducing chemicals to the human body coursing an imbalance thus creating an adverse reaction. Businesses will respond in much the same manner.

A negative reaction will occur when

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

ask to change. When you ask your prospect to make a decision on your products or services you are creating change thus creating an environment for a negative reaction. Change is best served when it evolves i

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

a progressive and unmistakable manner. That house plant if just moved a few foot per day to the other side of the room has no plant shock. Wrap your body in fall clothing and covering your head will prevent i

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

Combination pro

lness according to Cora Mims. Medicines taken in smaller douses allow the body to adjust thus no negative reaction to the change. The same rule applies in business-to-business selling. Walk, don’t run is the p

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

ocess method. Allow the process to evolve and advance at a pace agreed upon by you, and your prospect business. Adding value to each step.

Features
GRADUAL- Change must be accomplish by degrees. A step-

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

y-step process is the key to getting a prospect to agree to purchase your solution. Crawl, walk then run will insure a win every time. Start the change off slow and easy.

PROTECTIVE-Guarded is the watch word

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

f the day when asking a prospect to make a decision. That change will effect the status of their job, effect how his/her peers view them in the future and that decision/change can effect the home life of the de

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

ision maker. As good as your solution is to you it maybe the wrong thing to that decision maker. You must offer some protection with your solution. Protection to eliminate the risk and cover damage.

MEASURED

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

A tea spoon full or a shovel full. Which solution is best to solve the pending problem? Many times a tea spoon is easer to swallow than a shovel. It cost less, it has less risk and it moves through the system

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

Following aspects would a

with out interruption of day to day function. Don’t use a cannon to kill a fly.

COMFORTED- Ask anyone what they desire most in life and you will get many different answers. Every answer will lead back to one

dd to the challenges in developing combination products:

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

ord comfort. They want a new car, more money larger home, better spouses, smarter children or a beautiful garden. They want all these thing because they need to be comfortable. Have you made the prospect com

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

ortable with your solution. How? Ask the question. Are you comfortable with the solution as designed. Ask as many times as you can.

Action to be taken
SEVEN STEP IN THE EVOLUTION

Step 1. Understand cle

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

rly the mission of the company's changes. Relate these changes directly to your product or service. Outline the value in the smallest of detail. Explain them as though you are speaking to a three year old ch

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

ld.

Step 2. Locate where you are at this time and place within the company’s buying process. If you are anywhere but the start of the process you must work smarter to destroy the competition.

Step 3. O

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

Professional from academic institutions, pharmaceutical industries, health care indust

tline where your prospect wants to go with this change. Gain agreement from the prospect. Update this outline often.

Step 4. Outline names and titles of key personal effected by the change and understand h

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

w change will effect them and their staff. Sell them on your solutions.

Step 5. Design a time line listing the actions you must take with on this time line that ends on a date for change must accuse.

Step 6

.

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

Weekly validate your time line and make any adjustments needed and have them approved by the director of change/decision maker within the prospect company.

Step 7. Three weeks before the change must be agr

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

Companies that provide selfless information through particip

ed upon take your agreement to the prospect for a decision making review.

This is also a trail close. Ask for the order with you pen in hand. At this point you will get a clear picture of where you stand

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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