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  • Useful Advices - Fear Factor

    What’s the biggest threat to your company? Competition? Regulation? Changing technology? Maybe you should put fear on your list. Fear is a small word that somehow touches our lives in a big way. Fear of danger is a survival mechanism. Fear of the change and the unknown is a destructive force that can c
    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
    onsume workplaces and degrade the performance of our companies. As leaders, one of our most important jobs is to ensure that fear does not take root.

    The way to diminish fear in the workplace is direct and clear communication. This is often more easily said than done however. Even leaders with the bes
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    t intentions wind up sending mixed messages, what experts in organizational behavior call meta messages. How so? The way in which you couch the message itself—the words you use, your manner of speaking—communicates additional, sometimes conflicting information. Whom you communicate with sends another m
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ssage—and whom you exclude sends still another.

    For example, Jane became VP of a small consulting team after a merger. She was well respected for her leadership and determined to make the integration as smooth as possible. She assured team members that she would meet with them and keep everyone in the
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    loop. Soon, however, Jane was being pulled into meetings with her new boss, leaving her direct reports without a leader. She was also traveling more. She sent emails, assuring everyone that all was well and promising to get back to them later.

    Jane thought she was being a good leader. She was absorbe
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    by what she felt was the most important priority – getting the story of the new merger clear with her boss. But the mixed message of assurances to her direct reports and her unavailability proved destructive.

    Within a short time, her team was disconnected from the acquisition activities. They started
    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
    to talk to people throughout the company, and got more mixed messages about what was going on. Within a few months, rumors of worst-case scenarios (bad acquisition; culture conflicts) began to circulate.

    As fear took hold, employees:

    - Began to distrust Jane’s leadership capability

    - Turned to othe
    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
    leaders outside her team for advice and information

    - Created concentric circles of communication (gossiped), building mountains out of molehills

    As a further consequence:

    - Performance in the team went down

    - Jane felt disappointed

    - Jane grew angry with team members whom she perceived as no lon
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ger committed to their jobs

    - What Jane overlooked is that our sense of security and well-being is profoundly affected by how much we are kept in the loop; in the absence of clear, consistent and regular communication from the leader, fear takes over.

    Employee fear takes hold when people in positions
    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
    of authority are suddenly behind closed doors, speaking in hushed tones, refusing to address rumors directly and so on.

    Ironically, this attempt to avoid communication conveys a very clear message: Something is brewing that is so bad that the boss is afraid to talk about it.

    That, surely, is not what
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    the boss intended. Indeed, Jane was doing everything she could to make sure her team, her direct reports, would continue to have a key role and that the lives of her employees would not be disrupted.

    The lesson: A great leader is able to put herself in someone else’s shoes—to see how certain actions
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    (or a lack of actions) look from the employee’s point of view. We call this empathy. In being empathic, the leader creates a sense of calmness and control that sustains a sense of forward movement, security and direction. Unless the leader sets a clear and explicit context for this type of communicatio
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    and communicates often, employees are left with little choice but to create their own “worst case scenarios.”

    What elevates Fear?

    - Lack of shared focus, purpose and vision. This creates confusion

    - Lack of company-wide communication, which opens the door to paranoia (the ultimate fear response).

    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    - Lack of interpersonal communication causes a negative emotional response on the part of the individual. If you can’t speak directly to every worker, make sure a supervisor does. Business leaders make a mistake when they don’t take into account the emotions of their staffs. Positive emotional connecti
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    n isn’t just something that feels good, it is good for business. Negative emotional response is destructive.

    - Lack of respect for others within the organization. That undermines security, causing resentment--another form of fear.

    - Failure to develop team agreements, strategies and decision-making p
    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
    olicies. This increases isolation and leads to fear.

    - Negativity and complaining, which become both the cause and effect of fear

    TIPS FOR LEADERS:

    When having vital conversations about the future and the organization’s direction, make sure you are listening. Repeat what employees say and ask questi
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ns. Listen to the logic and the emotion (pay attention to their mixed messages!).

    Pay attention to the subtext—what is implied by the questions.

    Become an expert at clarifying what employees are saying before drawing conclusions and making assumptions that may be erroneous. Keep asking questions unti
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    l you get to the real message that the employee is trying to convey.

    Keep an open mind. Even if you disagree with what is being said, your listening shows the employee respect and helps you understand employee concerns. Remember emotions don’t always reside in logic. Fear is an emotional response that
    .

    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
    you can avoid.

    Evaluate information without bias

    Respond rather than react. Show the employee that his or her concerns are valid.

    Accept responsibility for the impact of the way you are communicating with others

    WALK the TALK. Say what you mean and MEAN what you say. That will build trust and elimi
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    nate fear.

    Understand how unspoken fear can affect your business and deal with it by unraveling meta messages. It will have an immediate bottom line payoff.

    Employees who know where they stand can accept whatever reality the ups and downs of business bring to your company—and they can be OK with that


    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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