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  • Just Other Articles - Resolve The Hidden Cause Of Problem

    We have all been in a conversation or worked with someone, and we've all had something to say but debated whether we should even bother saying it. Or maybe you had an idea or advice to give and thought, "Should I say it or not? Ah, forget it, they probably don’t want to hear it, and it will probably just cause an argument. It isn't worth it."

    Before you stop to answer whether it is worth bringing up or not, consider these statistics:

  • An avera
  • 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
    ge employee loses seven weeks of productivity every year because of troublesome and unresolved communication issues.
  • Lack of open, honest communication is at the root of 80 percent of problems at work.
  • Nearly 75 percent of employees who leave their jobs do so because of communication issues with their boss — not money.
  • The number one factor that drives employees to be engaged in their job is their relationship with
  • ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    their boss.

    Now, put those statistics aside and answer this question. Sharing something or keeping it inside, which takes more energy? If you are like most people, keeping things inside is more stressful. When you finally share it with someone the outcome usually is not as bad as you feared.

    Having been “in the trenches” working with thousands of individuals from organizations of every size for more than a decade, we have discovered that the 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.

    oot cause of most problems is a lack of honest communication and the subsequent withholding of issues, information and ideas.

    How often have you said to yourself, “If they had just told me what was bothering them and what they wanted, I could have done something about it.” Or, “If I just had all the necessary information to do my job, I could have made a better decision in a fraction of the time and done it so much better.” Recently, a participant 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
    one of my seminars shared that his wife of more than 25 years told him she was unhappy and wanted a divorce. The worst part about this is that he never saw it coming. He never knew she was unhappy.

    Honesty is not only about telling the truth vs. telling a lie. That’s just what everyone talks about. Honesty is about saying what needs to be said and not withholding information and ideas.

    Most people are unaware how much simply not being honest hurts
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    relationships, curbs teamwork, stunts innovation, wastes millions in productivity and restricts the ability to generate new business. Unfortunately, some people think hording knowledge means power, while the reality is withholding can be toxic to every relationship at home and at work. Here are a few costly results of dishonesty:

      Poor decisions are made based on a fraction of the potential information.
    • When vital information is not
    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
    shared in a timely manner and expectations are not honestly managed, contracts develop problems and customers are lost.
  • Departments don’t share important information and, thus, can’t work effectively with each other.
  • Meetings become exasperating and unproductive because real issues are not discussed or resolved.
  • Co-workers avoid each other instead of working together and resolving issues.
  • People leave
  • 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
    their jobs because of unresolved relationship issues.
  • Instead of talking to each other, people hide behind e-mail.
  • Office politics and hidden agendas cause employees to spend time developing back up and contingency plans rather than focusing on the work at hand.
  • People do not feel free to share the innovative, raw and crazy ideas that could be refined to make the organization incredibly successful and profitable.
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    i>

    According to a national study, 91 percent of people lie on a regular basis, and, in reality, the other nine percent were probably lying. The truth is that all people lie or withhold to some extent. It’s not because they are malicious or ethically flawed (though that can be a problem for some); it is primarily because they are afraid of hurting someone’s feelings, afraid of retribution for being honest, afraid it will permanently damage their
    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
    relationships, afraid that it will affect their careers, etc.

    People are afraid of the reaction they’ll get when they share what they feel or what they know. They wonder: Will others be appreciative or resentful? Will they take the feedback to heart or become defensive? Will I be respected for saying what needs to be said or will I be seen as a troublemaker? Fear keeps people from sharing vital information causing organizations, employees and famil
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    es to suffer.

    When we reduce fear, we can increase honest, open communication — information, thoughts and ideas — that can improve and have a positive impact on the organization. People want to be upfront and express their ideas. As I have already mentioned, it takes more emotional energy to keep things inside than to let things out. The key is to create an environment where people feel safe to do so.

    The Solution: Three Keys


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

    Following aspects would a
    f working with thousands of people have uncovered three keys essential to getting people to stop withholding, say what needs to be said and get others to say what needs to be said. By instituting these three keys through specific real-world strategies, relationships can be fixed and grow at home and work, and organizations can boost teamwork, increase productivity and generate new business. As we all know, no matter how great we are at something we c
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    an always improve.

    Key 1. We all need to be aware that people tend not to be open and honest and withhold information and ideas. For example: When we say we are too busy when we really don’t want to deal with someone; when we say everything is fine, when things are not because we fear potential backlash if we are upfront. We need to recognize others are doing the same to us.

    Many of us don’t realize that we often unknowingly encourage other
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    not to be honest with us by getting defensive or upset when someone tells us bad news or unpleasant feedback. So the next time that person has to tell us something important, the poor bearer of bad news is too scared to be honest and instead does not say anything. Awareness is the first step to changing the situation.

    Key 2.
    Leaders need to advocate, demonstrate and reward honesty. We are all leaders at home and at work. We lead our fami
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ies and at work we lead our boss, our co-workers and our employees. As leaders in our lives, we need to not only advocate the value of honesty but also consistently demonstrate it through full disclosure, encouraging feedback and positively reacting even when people give us unpleasant news. This also means apologizing and taking full responsibility when we make mistakes. Remember, there is no statue of limitations on apologies. If we owe someone an a
    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
    pology, we need to apologize; just because they don’t bring it up doesn’t mean they have forgotten or that they are over what happened. So model and reward the behavior you seek in others.

    Key 3.
    You must provide the strategies and skills for candid, honest communication and develop an environment where others feel safe to practice them. We must learn how to say what needs to be said. We must be aware of the difference between honesty and
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    brutality, clear on the facts and careful not to accuse or blame. Honesty is not about sharing all of our opinions, because often people don’t care about our opinions. Take responsibility for your “mind chatter” and how you see things. Check-in with what we “imagine” (opinions, thoughts and conclusions) by asking effective questions from a sincere position that you may be missing something and are not fully aware of what is going on. Make requests, s
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ggest ideas, focus on finding a solution, state the benefits for others to fulfill your request and share ideas.

    When everyone stops hinting around an issue and are transparent and candid, issues and problems can be addressed and resolved, relationships can be transformed, people can do their jobs significantly better, and organizations become more innovative, teamwork improves and revenue goals are achieved. Both our home and work life becomes more
    .

    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
    enjoyable and rewarding. By using these strategies and techniques, many have saved their marriages, resolved issues that had never been resolved and get promoted when it had seemed impossible.

    So here is the challenge — what are people withholding from you? The scary part is we don’t know. The good news is we can take action and do something about it.

    Honesty takes strategy, skill and practice. After all, you don’t go out and exercise once and dec
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    are “Now I am healthy.” Instead we must work on it. The idea is to make improvements — not to be perfect but to be willing to feel awkward. If we do, the benefits are enormous. Just imagine if you and everyone around you really talked more openly and shared ideas and wisdom with each other. Ask everyone in your life to read this article, discuss it and then share what you are going to do differently. The way to change your future is by changing today


    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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