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    Consequences of Not Giving Effective Feedback

    Let’s take a look at some typical examples of what goes on in work environments when managers don’t give good feedback.

    Example #1: John has been working at his new job for one month. On his first day at work, Wilma, his boss, showed him what to do and got him started on a project. Sin
    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
    ce then, Wilma has communicated with him mostly through voice mail and e-mail. She walks past his cubicle and says hello a few times each day, but there hasn’t been much other communication. John is assuming he is doing his job properly, but he really isn’t sure.

    Analysis: There is no feedback here. John has no idea whether he is d
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    oing his job properly.

    Solution: Wilma should have given John a detailed job description on the first day. She should have gone over his first project as soon as he finished it, making certain he understood the task and completed it properly. She also should have checked in with him regularly to make certain he was doing his job co
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    rrectly and to see whether he had any questions.

    Example #2: Stella works in an office. Yesterday, she spent several hours filing a huge stack of folders that her boss had given her in the morning. When she got to work today, her boss came over to her desk and yelled, “Stella! You did those files all wrong! Don’t you listen?” He sa
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    id it so loudly that Stella’s three office mates turned toward her in shock. He went back into his office and slammed the door.

    Analysis: This manager’s behavior is abusive. It lowers her self-esteem and frightens her coworkers. An atmosphere of fear also lowers productivity and encourages sabotage and turnover.

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

    Combination pro
    d have delivered the feedback calmly and in private. He should also have asked her for her understanding of the task; perhaps there was a reason for it being done the way it was. Third, he should have been specific about what she did wrong.

    Example #3: Angela asked Steve, her assistant, to call a list of 20 clients and set up phone
    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
    interviews for next Thursday and Friday (the 20th and 21st). She provided Steve with an updated list of phone numbers and told him the hours she would be available to speak with the clients. When Angela came back from lunch today, Steve had left a list of interviews on her desk. He has set them up for this Thursday and Friday (the
    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
    13th and 14th). He also has written, next to four of the clients’ names, “wrong phone number.” As she picks up the phone to reschedule the first client, she says to herself, “See, you just can’t get good help these days.”

    Analysis: As far as we can tell, there was no feedback to this employee.

    Solution: Employees have a hard time
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    learning if they are not given feedback. This manager should have talked to Steve calmly and in private. She should also have asked Steve what he understood the task to be and why he scheduled the interviews for the wrong dates. Finally, she should have asked Steve to reschedule the calls for the correct dates.

    Steps for Giving Fee
    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
    dback

    Now that we’ve looked at a few examples of what can happen when performance feedback isn’t given effectively, let’s talk about some principles for doing it well. The five simple steps are:

    1. Describe the situation.

    2. Ask the employee for his or her view of the situation.

    3. Come to an understanding of the situation.

    4.
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    Develop an action plan to resolve the situation.

    5. Agree to follow up later to make certain the situation has been resolved.

    Let’s use the third example above to illustrate how this might look.

    1. Describe the situation. “Steve, these appointments are all scheduled for the 13th and 14th. I asked you to schedule them for the 20t
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    h and 21st.”

    2. Ask the employee for his or her view of the situation. “Tell me, what was your understanding of what I asked you to do?”

    3. Come to an understanding of the situation. “So you just misunderstood what I wanted. I had written the dates in my note to you, but you didn’t read it thoroughly before you started making th
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    e calls.”

    4. Develop an action plan to resolve the situation. “I would like you to re-schedule all of these appointments before 5:00 today. What will it take for you to do that?”

    5. Agree to follow up later to make certain the situation has been resolved. “I’ll check in with you at 4:30 to see how you are doing with this.” At 4:
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    30, stop by Steve’s desk and ask, “How are you doing on your calls?”

    Principles for Giving Feedback

    Let’s take a look at some other issues to consider when giving feedback to someone who works on your team.

    1. Put it in writing. Feedback is most effective when it is written down. Having it in writing increases the chances that it
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    will be understood. For example, Angela could simply note the dates and times she is available and hand it to Steve. She could also write “by 5 P.M. today” at the top.

    2. Be sensitive to people’s feelings. Some managers think they don’t need to worry about the employee becoming upset. They think that as the boss, they have the rig
    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
    ht to tell people what to do and not worry about their feelings. This is a big mistake. Being concerned about other people’s feelings is important in any situation. Effective managers demonstrate concern for the self-esteem of their team members. This doesn’t mean withholding criticism or ignoring problems.

    3. Focus on your entire
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    team, not just the new members. New employees are not the only ones who need performance feedback. All employees need ongoing feedback.

    4. Feedback should be as specific as possible. People have a difficult time responding to instructions that are vague and unclear. It is important to check for understanding; avoid assuming that yo
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    u are on the same wavelength.

    5. Think it through. Always take the time to plan what you want to say before giving feedback. Taking the time to gather your thoughts and clarify what you want your feedback to accomplish increases the chances that you will communicate clearly.

    6. Ask first. Get the employee’s point of view before yo
    .

    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
    u state what you think should be done. People are more receptive when they have a chance to explain themselves first. You might also learn something unexpected that will explain the situation or change your point of view.

    7. Don’t withhold. It is not a good idea to hold back your negative observations when employees are new. You do
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    n’t want to criticize too much and cause them to feel discouraged, but remember that people need to know how they are doing.

    8. Follow up. If you see that the employee corrected a problem situation, you still need to follow up. When you follow up, you are telling employees that you are being thorough and that the work is important.


    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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