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  • Advice You - The Death of Management

    "You cannot treat a patient if he doesn't know he is sick." - Bryce's Law

    INTRODUCTION

    Epitaph:
    "Here lies the body of 'Management,' Who at one time moved mountains but was put to death by government regulations, social mores, office politics, and general apathy. R.I.P."

    I have a good friend who was recently elevated to the job title of "Systems Manager" at a large Fortune 500 company in the U.S. Midwest. As someone who has been in the Information Systems field for over 30 years now, my interest was piqued and I asked her how big of a staff she was going to manage and what kind of systems she was going
    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
    to be responsible for administrating. She told me she had no staff and her responsibilities primarily included going to user sites and helping them setup their laptop computers with office suites and pertinent Internet software.

    This is certainly not how I have come to understand the concept of a "Systems" person or, for that matter, a "Manager." What she described was more of a technical or clerical role as opposed to one of management. But I guess the times are changing.

    I always viewed "management" as a people oriented function, not a mechanical function (which is why "man" is used as part of the word). I define it as, "gettin
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    g people to do what you want, when you want it, and how you want it." But perhaps I am beginning to date myself as more and more "managers" are appearing with fewer and fewer people involved. Even though the title is flourishing, I contend true management is becoming a thing of the past.

    WHY IS MANAGEMENT DISAPPEARING?

    First, we have to understand that managers are in the business of conquering objectives and solving problems in the workplace through people. If we lived in a perfect world where everyone knew what they were suppose to do and when they were suppose to do it by, there would not be a need for managers. Ine
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    itably, this rarely occurs as people are social animals and rarely agree on anything, particularly on how to perform a given task. Hence, a manager is needed to establish direction and referee. As such, managers are the field generals for their departments.

    There are three basic attributes of a manager: Leadership, Environment, and Results. Let's consider each separately and how they have evolved:

    1. LEADERSHIP

    To properly coordinate human resources, an effective manager should always be at least one step ahead of his staff. This requires visionaries who inspire confidence in their troops and can set them marching 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
    right direction. The problem though is that little, if any, planning is being performed in corporate America. Instead, we are content to react to calamities as opposed to looking into the future and trying to anticipate problems. As a small example, we are now embroiled in a tempest over the Hurricane Katrina disaster in New Orleans. Engineers have long known that the levees used to keep the sea out of the city were inadequate for a category four or five hurricane (Katrina was a category four). In fact, I saw a documentary on this very subject just weeks prior to the disaster. Now, we have local, state and federal government a
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    gencies rushing to correct the problems (and doing a lot of finger pointing in the process). As costly as it would have been to fix the levees, it would have been a spit in the bucket when compared to the costs to clean up the aftermath.

    In the corporate world, Detroit is reeling from the types of automobiles now being imported into this country. Asia has stolen Detroit's thunder who now finds itself offering cash incentives to stem the tide. It is no secret America has developed an ever-increasing dependency on foreign oil, and is now saddled with an aging oil refinery infrastructure and a shaky economy. Why then was Detroit su
    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
    prised to see their market share take a nose-dive in favor of quality fuel-efficient automobiles from overseas?

    The point is, our planning and leadership skills are at an all time low. Why? Because it is easier to react to a problem than to do a little planning; easier, but costlier. Let's face it, planning is hard work and, as the old adage goes, "You can pay me now or you can pay me later, but you are going to pay me." Planning is a projection into the unknown and involves a certain level of risk that most people are not willing to assume (and are afraid to do so). Consequently, our society is more interested in safety nets t
    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
    han in taking risks. I guess this is why I admire gamblers who mentally calculate their odds for success and are unafraid of taking risks.

    Nonetheless, American competitors (and our enemies) fully understand our weakness as planners and are not afraid of taking the risks that we balk at. As a result, they will continue to take advantage of us until such time as we get some serious leadership.

    2. ENVIRONMENT

    In order to set workers to task it is necessary for a manager to establish a suitable work environment. This includes:

    • Defining the location of the workplace, hours of operation, and corporate policies to be
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    observed (e.g., payroll, benefits, performance reviews, etc.).

  • Defining the methodologies, tools and techniques to be used by the workers in their assignments.

  • Defining the corporate culture - Although this is normally defined by the company overall, the astute manager establishes the ethics, customs and social intercourse to be observed within his area of responsibility (a subculture). By doing so, the manager has defined the code of conduct in the department denoting what will be tolerated and what will not.

    As part of the corporate culture, the manager defines his own personal style of management, for example:

      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
      The types and level of discipline, organization, and accountability expected from the workers.

    • Will the manager try to micromanage everything (top-down) or empower his people, delegate responsibility and manage "bottom-up"?

    • How employees are evaluated and rewarded; by accomplishments or by political maneuvering.


    The manager's objective is to create a homogeneous working environment whereby everyone is "rowing on the same oar" towards common objectives. Unfortunately, the problem here is that our society is now more inclined to accept rugged individualism as opposed to team effort. For example, employees are commonly rewa
  • ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    rded based on individual initiative as opposed to group effort. Between this spirit of individualism and government regulations that embolden employees to resist the company, loyalty and teamwork are at all-time lows and apathy and restlessness permeates corporate America. Such spirit disrupts the harmony of the work environment, thus compounding the problems of the manager.

    3. RESULTS

    Ultimately, the manager is charged with the responsibility of producing a product or performing a service. As such, the manager must establish and prioritize assignments, and assure they are accomplished in a timely and cost effective m
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    anner. This requires managers who can articulate assignments and coordinate resources towards this end. Sounds pretty simple, right? Then why are we failing in this regard? Three reasons:

    • Managers are more interested in gamesmanship than actually producing anything of merit. They have developed a "fast track" mentality whereby managers have little interest in their current job and want to advance to the next plateau in their career. "Long-term" planning is no longer measured in years, but rather in months or weeks (a "long-term" project is now considered three to six months in length). Consequently, managers are primarily
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    nterested in quick and dirty solutions which will see them through their tenure of office, but will create burdens later on for their successors. Managers now spend more time scheming and maneuvering than worrying about getting the job done. What's the sure sign of such a manager? He/she knows the latest buzzwords and is always "politically correct."

  • Managers are no longer results oriented, Instead, they are more focused on the process or mechanics of getting a job done. Although it is desirable to be well organized and precise in our work effort, it is for naught if you cannot deliver what you are charged to produce. The manager ne
  • cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    eds to be focused on deliverables, not mechanics (with apologies to the ISO 9000 folks).

  • Managers no longer hold people accountable for their actions. This is due, in part, to government regulations that are more concerned about the rights of the employees as opposed to the manager's. As a result, managers spend less time managing and more time supervising people. Understand this: there are substantial differences between management and supervision; the two are most definitely not synonymous. Supervision is much more "hands on" with employees being continually watched and directed in their work assignments. Managers should manage mor
  • tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    e and supervise less, and employees should do more self-supervision. Unfortunately, this philosophy is not in vogue these days. Workers no longer seek responsibility and prefer to be told what to do thereby they cannot be held accountable if something goes awry. This alone says a lot about our society and is worrisome to me.

    Let us never forget, unless you can deliver what you are charged to perform, you are a failure as a manager. Consider the numerous coaches and managers in the world of sports who have been fired over the years, not necessarily because they didn't run fine programs, but because they lost sight of the end r
    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
    sult: winning.

    CONCLUSION

    What I have described thus far pertains primarily to large corporations. Management is still alive and well in small businesses that are not encumbered with bureaucracy and need to manage simply to survive. I have also been primarily describing corporate America, but many of these bad habits are creeping into the management style of Asian and European companies as well.

    Now and then, I like to make an analogy between management and dieting. There is nothing magical about losing weight; you simply watch what you eat and get some exercise. However, millions of dollars are spent on the latest diet
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    craze, usually to no avail. The same is true with management; you simply need some leadership, organization and follow-up and you will get the results you want. However, it seems companies today do everything but manage.

    Beyond this, our social fabric and government regulations discourages effective management. Instead of discipline, organization and accountability, we are more concerned with nurturing free-spirited individualism, gamesmanship, and chasing panaceas. In many cases, managers are inhibited by the press who scrutinizes decisions, particularly in the government sector. Fearing to make a bad decision, managers suffe
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    r paralysis and nothing is accomplished.

    Bottom-line, corporate America is no longer managing; instead, we are playing games or as I like to call it, "Rearranging the deck chairs on the Titanic." In other words, as the ship is going down, we tend to focus our attention on everything other than saving the ship or passengers. In the past we have talked about Theories X, Y, Z for describing different styles of management. Perhaps we should describe today's management style as "Theory Zero."

    What is needed is someone who isn't afraid of taking the reigns and is allowed to run the department to produce the necessary results - th
    .

    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
    t is the job of a manager. Let me give you a small example. Recently, I attended a meeting for a nonprofit organization who wanted to draft legislation for the association. The meeting started out pleasantly enough but quickly slipped into an uncontrollable series of arguments. I could tell by the confused look on the faces of the attendees that the meeting was out of control and so I grabbed the gavel and brought the meeting to order. I next divided the group into subcommittees to discuss the different issues and gave them a deadline to produce a rough draft of the legislation. Within each subcommittee I appointed a chair
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    man, a secretary, and someone to research the legislation. I then went outside to smoke my cigar. When I came back to the room, bedlam had been replaced by quiet organization. The legislation was drafted according to my instructions and the members left the building saying it was one of the best meetings they had attended. Why? Because a manager took the gavel.

    One last note which I will specifically address to my colleagues in the IT Industry; In my 30 years in this field I have never encountered a technical problem that cannot be conquered by good old-fashioned management. I'll bet this is true in any industry, not just IT


    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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