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    WHAT IS A WHY?

    Your WHY is your motivation and reason for why you have chosen the path you are on.


    It is time to stop and look at your WHY when:

    - You begin your business journey

    - You find yourself putting forth a great deal of effort with very little outcome

    - You are feeling defeated about the path you have chosen

    - You are disorganized and unfocused

    - You don’t feel like you have what it takes
    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

    If you can identify with any of these scenarios, then let’s take some time to really evaluate where you are and where you want to go.

    HOW TO DEVELOP A WHY

    To develop your WHY it is important to be certain of two things:

    1. What was your MOTIVATION?

    2. WHY did you choose your particular business?



    What was your MOTIVATION? WHY did you seek the business you are in?

    Many people begin a job or a business for basic
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    reasons; pay bills, pay for braces for children, pay for sports for children, pay off debt, etc. These are in essence your goals.

    To get a clear picture of what your goals are, break them up into 1 yr, 3 yr and 5yr goals. It may look something like this:

    1 yr; Help with bills, Pay for soccer, remove credit card debt.

    3 yr; Pay for braces, Get new driveway, Go on a family vacation to Hawaii.

    5 yr; Allow spouse to not work, Purchase new car, Pu
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    rchase new house

    WHY you chose your particular business?

    What were your reasons for choosing your particular business? Being certain of why your particular business works for you keeps you from being side tracked.

    Your reasons may look something like this:

    - Loved the products

    - Simple compensation plan

    - Multiple ways to earn an income

    - Good profit margin

    - Low start up costs!!

    Remembering WHY you chose this business will keep
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    you focused and moving forward. The longer you are in your business the more important it is to be clear about WHY you chose your business in the first place. Other businesses and ideas will come along and tantalized you. But in the end, as you keep clear of WHY your business works for you WHY it is such a good fit for you, it will protect you from moving me away from your purpose and vision. Each sidetrack slows you down. You don’t want to be
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    slowed down. You want to keep moving forward!!

    We have looked at What a WHY is, Why a WHY is necessary and How to Develop a WHY.

    Now lets look at HOW TO USE A WHY?

    In business there are going to be ups and downs. Times when you feel on top of your game and times when you wonder what in the world you have gotten yourself into. Keeping your WHY in front of you becomes critical as you go through the ups and downs. It is very easy to quit
    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
    in life when things get difficult.

    “Most people give up just when they're about to achieve success. They quit on the one-yard line.

    They give up at the last minute of the game, one foot from a winning touch down.”

    Ross Perot


    PUT YOUR WHY TO WORK



    Do this as a protective measure for yourself and your business

    Protective Measure

    Continually review your WHY. Look back at WHY you sought out a business and
    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
    WHY you chose your particular business. This is so powerful.

    As you continually review your WHY you may need to modify it for a couple reasons:

    Modify your WHY when:

    1. You are able to acknowledge you’ve made accomplishments and need to make new goals.

    2. Your mindset shifts.

    It is so important to Acknowledge your accomplishments and then set new goals. There is so much power in checking things off. As you review your
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    WHY you will probably notice that you have in fact met some goals. Acknowledge your accomplishments and move forward with purpose.

    Your WHY may also need to be Modified as your mindset shifts. As that little voice telling you “no way, you can’t do this,” gets softer and softer and you begin to see what really is possible, your WHY may change as well. Your dreams may become bigger as you SEE AND BELIEVE the potential.

    As our mind shifts and 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
    begin to label yourself or see yourself differently, your boundaries expand as well. You may find yourself shifting from “A person who felt trapped in their finances, to a business owner who had a sense for business and was willing to take risks. And, those risks brought you achieved goals.

    We’ve looked at ways to use your WHY as a protective measure, now let’s look at some ADDITIONAL WAYS TO USE OUR WHY

    1. Allow it to keep you motivated when…
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    - You don’t want to get up in the morning.

    - You need a goal to drive you.

    2. Allow it to keep you focused when…..

    - You find yourself sided tracked. Don’t beat yourself up. Just review you WHY and get back on track.

    3. Use it to teach others when…

    - Your employees or team members need motivation and focus. Draw them back to WHY they started this journey in the first place.

    WHY A WHY?

    Because…

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

    Following aspects would a
    what allows you to move your business goals past a wish and a dream

    and move you into action and total saturation of the mind with new concepts

    to replace the ones that can stop you and your income.


    You can go through the motions and develop your WHY, but unless you make a shift on the inside and really believe and understand what it can do for you, there will be no change on the outside….no results.

    There MUST be a shi
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    t on the inside to catalyze one on the outside.

    Write and Rewrite Your Goals. It is a constant process.

    The more you write and rewrite your goals and the more you think about them, the clearer you will become about them. The clearer you are about what you want, the more likely you are to do more and more of the things that are consistent with achieving them. AND, the stronger your mindset will be. Meanwhile, you will do fewe
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    r and fewer of the things that don't help to get the things you really want.

    Seven Step Process for Achieving Goals


    First, decide exactly what you want in each area of your life. Be specific!

    You notice I said EACH area of your life. As we develop our business it will be much more successful if we are developing our WHOLE self, and not just the business.

    “Personal development is your springboard to pe
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    sonal excellence. Ongoing, continuous, non-stop personal development literally assures you that there is no limit to what you can accomplish.“ -- Brian Tracy

    Make sure you set goals for your personal life as well as your business life. Be specific.

    Second, write it down, clearly and in detail.

    Writing it down and pulling it from your mind to the paper, helps you commit to the task. It helps you become accountable to your goal.
    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

    Third, set a specific deadline. If it is a large goal, break it down into sub deadlines and write them down in order.

    Example: Pay orthodontist bill of $200 the 30th of each month.

    Fourth, make a list of everything you can think of that you are going to have to do to achieve your goal.

    Example: To bring in $200 a month I would need to sell x amount of candles. That means I would need to have x amount of parties, or do a farmers ma
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ket, etc.

    Fifth, organize the items on your list in the proper sequence and priority.

    Example: Prioritize list of possible actions to achieve your goal according to what works for you and your family.

    Sixth, take action immediately on the most important thing you can do on your plan. This is very important!

    Seventh, do something every day that moves you toward the attainment of one or more of your prioritized goals. Maintain
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    the momentum!

    Review Your Goals Daily

    Once you have written your goals down, you will need to study and review your goals every day to be sure they are still your most important goals. You will find yourself adding goals to your list as time passes. You will also find yourself deleting goals that are no longer as important as you once thought. Whatever your goals are, plan them out thoroughly, on paper, and work on them every single day.
    .

    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
    This is the key to peak performance and maximum achievement.

    Action Exercises


    To apply this law immediately:

    Make a list of ten goals that you would like to achieve in the coming year; both personal and business. Write them down in the past tense, as though a year has passed and you have already accomplished them.

    1.

    2.

    3.

    4.

    5.

    6.

    7.

    8.

    9.

    10.

    From your list of ten goals, ask yourself, "What one goal, if I were
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    to accomplish it, would have the greatest positive impact on my life?" Whatever it is, put a circle around this goal and write it below.

    My single most effective goal is:

    Now, practice the seven-step method described above on this goal. Set a deadline, make a plan, and put it into action and work on it every day. Make this goal your major definite purpose for the weeks and months ahead.

    Deadline:

    Possible Action Steps:

    Prioritized Action Steps


    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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