Advice You - Business

Go into any bookstore and you will find a big selection of self-help and personal improvement products. Most everyone (and I’ll bet everyone reading this) wants to improve. We know we need to get better, and we want to get better. We may want to improve

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

our personal relationships, our business capabilities, our ability to be disciplined, our desire to juggle four chain saws, or any of hundreds of other things. In that book store you can find books to help you do any of those things!

In many cases th

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

Examples of combination products may in

ugh, those books start half way through the process. After writing the last chapter about identifying our potential I realized that identification of our potential, while critical, isn’t the complete answer. It is only the first step.

If we want to r

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

each our potential, we must start by identifying our greatest areas of potential. With that knowledge, we must take a step-by-step approach to making that potential reality in our lives.

It is no different than a business identifying its core strength

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

in order to best capitalize on the opportunities they see. When we start our personal improvement program with identified strengths or potential, we ignite our personal rocket – and begin our trip to greater heights and achievements.

Here then is a s

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

Combination pro

ep-by-step process that you can use to convert your potential into results!

1. Identify it. I’ve already helped you do that. Whether you have followed those steps in the last chapter or are just aware of a skill you want to develop,

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

this is a necessary first step.

2. Claim it. You must believe in your heart that you have untapped skill and ability in this area. Once you have claimed it, you must proclaim it by telling yourself (preferably out loud) that you

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

RE assertive, you ARE a swimmer, you ARE supportive of others. (Fill in your own skills and potentials!)

3. Scope it. Next you need to think about what part(s) of you life you want to apply this new skill or ability in. Take time

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

to determine the areas of your life where you will use this enhanced skill.

4. Target it. Why do you want to develop this potential? How will you and/or those around you benefit from the development of this potential? What is you

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

goal? Answering these questions will help you stay the course when you get discouraged. Write these reasons and your ultimate goal down and read them often.

5. Plan it. A plan will help us achieve most anything more rapidly. W

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

uldn’t you like to reach your potential sooner than later? Then make a plan! Determine what you need to know and how you will learn it. Schedule time on your calendar. Think about the situations you want to practice in. Write your plan down and remem

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

Following aspects would a

ber to include timelines. This is a real plan. While it may not be as elaborate as a business plan, it is every bit as important. This is your plan!

6. Start it. Get started already. You might actually start as early as step

dd to the challenges in developing combination products:

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

, but I include it here because the scoping, targeting and planning is important too. Whatever you are trying to develop will require time and effort. The toughest step though is often the first one, so get started!

7. Support it.
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
> You may need to find support from many people and in many places. One way is to have a mentor. If you know someone who excels at what you are trying to develop, ask them to mentor you. You can also get mentoring from people indirectly, by reading ab
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ut their approaches, thought processes and ideas. (This is one great reason to read biographies and autobiographies.) Get support around you too. Find people close to you who will support your efforts and encourage, not discourage you. Identifying you
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
support system early on helps you get started. Having the support will help you get past the toughest times during your process.

8. Practice it. You won’t reach your potential in one try or in a week. I recently read a page on
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
the web that was promoting a workshop called Building a Million Dollar Practice. The tagline is what was memorable. It read “Hint – it isn’t about the Million Dollars.” That tagline tells the story – it is about the practice! Practice builds our skills
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
Practice broadens our experience. Practice creates new habits. Practice makes permanent. Perhaps that greatest key of all to developing our potential, is disciplining ourselves to practice.

9. Be grateful for it. When you rec
.

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
eive a gift from someone you likely send a thank you note. Being grateful for the gifts of our potential is just as important. By being grateful we begin to unlock even greater opportunities to use the potential we have nursed into skill, experience, an
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
habit. It isn’t too late to start. Reaching our potential has nothing to do with our age, situation or past. Using this process will help you to unleash the potential you identify to help you reach your professional and personal goals and objectives.

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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Advice You - Nine Steps to Help You Develop Your Potential

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