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    The final part of pretty much every strategic planning process is to identify and prioritize a set of goals that will move the organization forward in a specific timeframe to a desired future. While it is easy to define financial, sales and marketing goals, it is a bit harder to def
    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
    ine non-financial goals such as leadership development.

    To operate successfully in business today, it is necessary to gain a comfort level with risk, to support a culture of innovation, and to encourage ongoing learning. Whether your organization is looking to increase the value of
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    services, launch new products, or improve operating efficiencies, an advantage lies in your ability to unleash creativity.

    As you think about what needs to be focused in your organization make sure that you have a plan in place to develop and/or strengthen the skills, motivation a
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    nd creativity necessary to propel your business forward.

    MOTIVATION

    Even with a top-notch team, business leaders struggle with how to get the most from their talent and keep everyone motivated, especially in a tight market

    Studies and research show dramatic differences between wh
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    at leaders think motivate their people and what really does. Non-monetary motivators, such as employee recognition, effective training, a positive work environment and job rotation or career path changes are far more important than cash to most people. The most effective type of mot
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ivation comes from within. It goes a long way for most employees to work in a positive environment where everyone can freely express their ideas and they are encouraged to challenge themselves, to grow and to develop.

    To better understand the teams I work with, I sometimes use valu
    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
    es assessments. More often then not, I wind up surprising managers when they find out how many of the people on their teams thrive on learning as a top motivator.

    LEARNING ORGANIZATION

    Peter Senge's 1990 book "The Fifth Discipline" popularized the concept of the "learning organiza
    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
    tion"- organizations where people continually expand their capacity to create the results they truly desire. Thirteen years later, his rationale for learning is just as relevant. Organizations must be flexible, adaptive and productive to succeed.

    In "Business Think," authors Dave M
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    arcum, Steve Smith and Mahan Khalsa tell us "What used to be 'somebody else's' job is now everybody's job." You have just as much responsibility to think as the CEO. If you're the CEO, everyone in your company has just as much responsibility to think as you do. Maybe more! Is your
    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
    business tapping your team's commitment and capacity to learn at all levels? An effective learning organization:

    Highly values the desire to learn
    Develops the ability to think critically and creatively
    Devotes the needed resources for these activities
    Seeks new
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    and innovative solutions to problems
    Proactively seeks change, growth, and development in new
    Looks for improved methodologies and innovative tools and solutions
    WHERE ARE THE DEVELOPMENT NEEDS IN YOUR BUSINESS?

    Conduct your own assessment with the following quest
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ions:

    LEADERSHIP

    Are you assertively responding to new opportunities? Is all that needs to get done getting done? Is everyone in the organization inspired, involved and rewarded? Have you developed a meaningful mission and a motivating vision to drive the business? Do you emphasiz
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    e innovation? Do you have a plan to develop and introduce new products/services in the future? How would you rate communication both internally and externally? Does your organization score high marks in the ability to deal with conflict, change?

    Leadership skills are not just for
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    people at the top. Leadership is a competency that everyone can continually improve. Good leadership skills will help others expand their perspective and encourage initiative.

    TIME MANAGEMENT

    What percent of time is spent putting out recurring fires? Do you spend the largest port
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ion of time doing the right things? How much time do you spend each day in integrating your long-range and intermediate-range plans into your daily activities?

    INNOVATION

    Do you offer mental stimulation and creative challenges? Is there a forum to help make sense of the situations
    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
    you as a business face? Do you inspire the creative process by discussing the realities of a situation or problem and ask for help to determine which course of action will best meet the challenges? Do you help people develop ideas into valuable solutions?

    ALTERNATIVES

    When most p
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    eople think of training, they think of sending employees away from their jobs for two or three days. This is certainly an option, but there are many others. Why not consider:

    Substituting a 1-2 hour staff meeting with a workshop.
    Launching a new project team with a team skill
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    s training.
    Using a facilitator to teach team skills while the team works
    Incorporating training into a multi-day meeting.
    Supporting a company-wide initiative with a short workshop.
    Setting up "lunch and learns," or breakfast seminars.
    Asking your clien
    .

    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
    ts to join you for some specialized training

    One-on-one coaching is another alternative to help individuals grow as professionals and contribute more fully to the success of an organization. Coaching can be time effective and have both a strategic and an immediate impact b
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    y providing "just in time" leadership learning. The opportunities for ongoing learning and development may feel at odds with current resource constraints. If you would like some guidance in putting together a cost effective strategy for your organization, we would be pleased to help


    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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