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  • Digg It - Provisioning/User Management System Upgrades: Part II - Building Awareness And Building Approval

    Somewhere in the world is a person who wants to see their provisioning/user management systems get a sorely needed upgrade. But they seem to be getting nowhere.

    The technical requirements are unarticulated. Key decisionmakers in the company are not aware this is needed. And the “project” is funded and without resources. How can someone who h
    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
    as the responsibility but not the authority get this upgrade to the next level?

    This article will provide practical guidelines on how to build awareness and get funding for a provisioning/user management upgrade. Upgrade is meant to include new hardware and software and also the supporting environment of business processes, roles, organizati
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ns, business rules, etc. This discussion will include techniques for overcoming the approval and implementation obstacles detailed in the previous article.

    1. Know What You Are In For

    Congratulations, you just signed up to become a change agent. They are easy to recognize because they have the arrows in their back! Usually they find their
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    own rewards – pride of having improving their company’s infrastructure against all odds, making new acquaintances along the way, and satisfaction of a job well done.

    Note it may take longer that you expected. There will be times of great progress and others of utter despair. Just keep at it and you will achieve your goal. And don’t forget to
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    have fun while you are doing it.

    2. Document the “AS-IS” Environment

    This should include not only the environment but also current metrics for id creation, deletion, changes across business units, and special cases. Great care should be taken in identifying gaps and risks in the current environment.

    3. Document the “TO-BE” Environment

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

    Combination pro
    te your own network identity roadmap if one does not exist. Base it on a combination of your own and colleague’s ideas, existing company policies and procedures, best practices, consulting think tank recommendations, and whatever else makes sense. Revise it as organizational and vendor realities change. By “setting a line in the sand” with y
    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
    our network identity vision, you will force other to either agree with you or identify their own assumptions, risks, and implementation next steps.

    4. Communicate Often

    You can never communicate enough about IT infrastructure needs! Use a variety of mechanisms to tell the story such as electronic/printed newsletters, bulletin boards (physic
    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
    l and electronic), web site, blogs, face to face, speaking at department meetings, in-house seminars etc.

    There are many things you can communicate – stories about the unsung heroes and heroines of provisioning and user management, current metrics, appropriate external meetings, webinars, and seminars, the “AS-IS” and “TO-BE” environments,
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    uccesses at other companies, the unsung heroes and heroines of provisioning and user management, and of course stories illustrating user pain thresholds. Keep the information interesting, educational, and continuous.

    5. Leverage Off of Other Company Success Stories

    This may some work. Continuously scan the trade magazines and the web for ot
    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
    her company success stories. Get the technical and management contact names if possible.

    Try to get hold of them. See if both types of contacts are willing to share their key documents with you and how they measured success. Even better, see if you can get them to speak to the corresponding folks at your company (Especially the management co
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    tact talking with your management.)

    6. Use Vendors and Outside Consultants

    Use them to educate your management and technical decisionmakers through webinars, seminars, and on-site meetings. Webinars are appealing because they are usually free, relatively short (typically one hour), can be done from your desktop, provide an opportunity for a
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    king questions and also saving a copy of the presentation.

    Outside consultants may be helpful by coming on-site and reinforcing your efforts. This may include a talk on the state of network identity, evaluating your current provisioning/user management strategy, discussing current and future vendor releases etc.

    7. Know Your Company’s Resou
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    rces

    Once you underway with your effort, you will see people fit into these categories:



    • Allies -- These are temporary and permanent employees who approve your general framework of problem diagnosis and proposed resolution. Keep these people best informed of all three categories through informal e-mails, 1 on 1 conversation, “brow
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    bag lunches” and brainstorming sessions. Use them to spread the word when appropriate. Possible candidates are those actually doing provisioning/user management, data management, security, HR, IT, and remote/roaming users.

  • Potential Allies – This type of employees may take some convincing. But once convinced, they are on your side forev
  • tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    r. They may need to be convinced through webinars, vendor talks, interfacing with their peers in other companies who have successfully implemented a provisioning/user management system, attending a conference etc. Find out what their objections are and work on overcoming them. Constantly communicate to them about user pain, successes in other
    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
    companies especially metrics before and after implementation.

  • Challenges – This employee will need the most convincing because of education, financial, emotional, and political concerns. Unfortunately, they are probably your approvers and will likely give you the least amount of time and attention. Your encounters need to be well planne
  • ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    and timed. You should have reached a broad level of consensus and awareness on this issue. The problem and remedy should be clearly defined and documented. It could prove invaluable to read several books or take a course on relationship selling.



    Conclusion

    You can succeed at getting a provisioning/user management upgrade at your com
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    any. It will take a combination of great timing, targeted communications, both “hard” and “soft” skills, and the right people backing you up. Good luck and please write to me about your progress along the way.

    For Further Information

    Abridean “15 Rules for a Successful User Management and Provisioning Project”


    .

    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
    ew">http://mysite.verizon.net/hrgerman/hal/Publications.htm

    Heiman, Stephen, Sanchez, Diane, and Tad Tuleja The New Strategic Selling 1998 Warner Book

    Microsoft “The Provisioning Challenge” http://www.microsoft.com/serviceproviders/mps/challenge.asp


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