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Some people make decisions without any difficulty, while others struggle. Are you having trouble making a decision? Do you feel overwhelmed by all the choices you have, and aren’t sure how to pick just one? No matter

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

how big or small those decisions might be, I can teach you how to strategically:

-- Define your decision and come up with alternatives

-- Determine what criteria you’ll need to help you make the decision

-- Make

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

Examples of combination products may in

he decision

"If we wait for the moment when everything, absolutely everything is ready, we shall never begin." – Ivan Turgenev, famous 19th-century Russian novelist, poet and playwright

DEFINING THE DECIS

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

ION AND ALTERNATIVESSTEP 1: What is it that you need to make a decision about? Maybe you have several choices to make, but start with one. Ask yourself a couple of questions that are applicable to your sit

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

ation, such as:

“What do I want to be doing for the next 6 months?” “What business am I going to start?” “What aspect of my business do I want to grow?”

STEP 2: Determine your primary goal and write it down.

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

Combination pro

For example, you might want to grow your business over the next six months. Therefore, your goal sentence might be: “I want to earn 25% more within the next 6 months.”

STEP 3: After you’ve written your goal

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

entence, begin brain-storming a list of ideas for how to achieve the goal. Below are some rules for brainstorming:

-- Write all ideas down – ideas are neither bad or good--they’re just ideas!

-- Do not judge or ana

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

lyze the idea – just write it down.

-- Make the process fun!

You do not have to generate a list of ideas in one sitting, but you may need to set some limits around how much time to spend creating your list. Be crea

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

ive in how you capture your ideas. Carry a small notebook with you so when an idea comes to you, you’ll be prepared and write it down immediately. I put stickies (Post-It notes) and pens in my purse, car, and bedroom

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

, so whenever and wherever I generate an idea I have a way to capture it. When I’m ready, I collect the stickies and add them to a master list I keep in my office. Just do whatever is easiest for you!

After you feel

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

you’ve completed your options list (or when the time you’ve given yourself to make the list has run out), ask someone you trust to read over your ideas. This person needs to be someone who has a positive attitude and

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

Following aspects would a

is supportive of your efforts! The person may come up with some options you hadn’t considered. Write them down! Remember, you’re not judging the ideas--just recording them at this stage.

DETERMINING THE CRITERIA

dd to the challenges in developing combination products:

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

AND EVALUATING EACH OPTION

STEP 4: Identify no more than 4 or 5 criteria that you will use to determine how well your options achieve the goal you’ve established.

Decision criteria provide checkpoints to

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

measure your options against your goal. Typical criteria fall into two categories:

Do-ability (do I have the money, time, expertise?)

Likelihood of Success (do they meet the goal

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

in time, revenue, fun factor?).

STEP 5: Using the criteria you’ve defined, evaluate each option. This process can be as simple, or complex, as you desire, and may be qualitative or quantitative

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

You may need to allow some time to experiment a bit with some ideas to test them out and determine how well they meet each criteria.

MAKING THE DECISION

STEP 6: Sometimes the winner(s) is obvious…you

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

Professional from academic institutions, pharmaceutical industries, health care indust

’ll just pick it and go with it. Or, you may immediately notice certain ideas drop to the bottom of the list and just need to be deleted because they do not support your business needs. When one option is not standin

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

out among the others, you may have to prioritize the options by weighting the criteria to help you evaluate the alternatives and make your decision.

BONUS STEP: Keep in mind, just because an idea may not fit

.

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

with your current focus; it may serve you later. Create a place to store those ideas--an “idea vault” to tap into the next time you need good ideas!

Terri’s keys to successful decision-making

-- Write it al

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

Companies that provide selfless information through particip

down!

-- Clarify the decision you are making

-- Know your goals

-- Be creative in coming up with options

-- Trust your gut

-- Don’t procrastinate!

Copyright 2002-2003, Terri Zwierzynski - Accel Innovation, Inc

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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