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    Over the years I have reviewed a large number of business operations. Following are a few of the major mistakes businesses make in their business operations

    Redundancies

    Most businesses, large and small, have too many things they do over and over which sap time away from being more productive. For instance, there are still business people who will write the same email
    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
    or letter from scratch instead of making a template or form letter that can be easily tweaked instead of being rewritten each time. Same goes with most of the operations and procedures the business has set up. Instead of creating procedures to streamline their operations so it can react quickly to a customer’s needs, they keep reinventing the same process when needed. The result is slow
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    service or response to a customer’s need.

    Action Plans not thought out for the Negatives

    Since most business owners are more sales oriented than operations oriented they sometimes will not look at what might happen if something goes wrong. This type of business person only wants to think of the positives and run from the realities that in every plan there is an 80% cha
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ce of something going wrong.

    The sales only or driven businesses fear that thinking negatively will cause them to be negative or the negative they are thinking will happen.

    The truth is thinking out a plan for all possible happening is positive. I am sure that if NASA had not sat down and thought out all that would go wrong in the attempt to put a man on the moon, I am sure it would hav
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    e never happened.

    A business with a sound operation will think out all that could happen as well as all they want to happen. This is a positive move for a well balanced business.

    Projecting an Unsuccessful Image

    One of the biggest mistakes I see too many business people make is to think that since they are in business they can act and dress the way they want to act and
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    dress. In most cases, this results in a less than professional look or behavior.

    Portraying an image of success is very, very important. Simply put, successful people are the people who have the money to spend. Successful people want to be around successful people, and successful people only want to do business with successful people. So, if you look and act successful chances are you
    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
    will be able to do business with successful people.

    The same goes for where people conduct business and where they go to network business connections. Nothing is worst to a business image than not holding to a high standard of business image. This does not mean you have to be in the high rent area to be successful. I have seen very successful businesses in some of the lowest rent secti
    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
    on of town. What made them successful is that their building, office, signage and immediate surrounds were impeccable.

    Portraying a successful image holds true online as well. Who you associate with online, how your web-site looks, what groups you join and what you provide online all will effect a business’ image.

    Being overly aggressive, obnoxious, arrogant and aloof is portraying a n
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    gative image. I see this mistake happen more than it needs to be happening and it is mostly done by two distinct personalities. First there is the person who is not aware of their negative image or does not care and thinks their action is popular or accepted by the people around them; and secondly the person who is desperate to generate business immediately. There are better ways to gen
    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
    erating business that appearing obnoxious or desperate. Nothing turns off a prospective client quicker than appearing foolish or needy.

    All of this is purely imagery, but is a fact of business life related to the operations of the business. If you look unsuccessful and hang out in places where other unsuccessful people hang out, then you will have a better chance of becoming successful.
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

    More emphasis on Sales/Marketing

    The classic mistake a sales and marketing driven business will make is to ignore the need for operations. I see it way too many times. Most of these type of businesses feel a sales driven organization will overcome all operational problems. They also will feel the operations side of the business is something that will take care of its
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    elf though high volumes of sales revenue.

    There is no argument that a business could buy its operations, but what is arguable is that by the time the sale is final the product is usually suppose to be delivered, which is the operations part of the business. I get asked all of the time to take a look at a person’s business operation only to find that everything they do is driven to make a
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    sale and that there is not any operations procedures set up to service the sale after it is made.

    The explanation I usually get is “I hate details”, or “I just love the excitement of the sale more than the boring operations of my business”. There are way too many people who are overly aggressive and live on the adrenaline of the excitement of making a sale who are going into business on
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    y to fail miserably. The result of a business that puts too much emphasis on sales and marketing will fail to deliver to their customers. These businesses without any operations muddy’s the water for other businesses in that industry who balance their operations with marketing sales.

    Lack of innovation

    I usually am brought in to look at a problem a business has with so
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    mething that deals with a change. Change is one of the biggest problems a sales driven business has to overcome. A business that has a sound operations or good operations manager usually will deal with change better than a company that feels that increased revenue will solve any problem that deals with a change. These companies that I am called in to look at what they are dealing with l
    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
    ck the ability to think outside the box or find innovative solutions. A business today has to be innovative to survive change.

    Lack of understanding customers wants and needs

    I am very surprised at the number of businesses I talk to or read about who go into business not knowing what their customers want or need. Like the many commercials that are on the internet and
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    television that use the shotgun approach of advertising, they do not know what the customer is wanting or needing, they are just selling what they have and attempting to make the viewer feel they need or want what they are selling. The businesses who understand what the customer wants and needs, markets to those customers and sets up an outstanding operation to service those customers nee
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ds and wants will be the businesses that succeed.

    The solution to all of these mistakes has to do with having a sound business operation. What shocks me the most is the many businesses who feel they do not need a Standard Operating Procedure. Most small business owners look at SOP’s as being something only large manufacturing companies or businesses with a large employee force need. Ma
    .

    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
    y also look at the need to develop an SOP as old fashion or “so 1980’s” and will fight the logic of the need for one so they don’t look to their contemporaries as not being “cool”.

    The fact is, every business needs to have a outlined process that clearly tells anyone how the business is run and how the service or product that is offered is delivered. The companies who feel developing a S
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    OP is too formal or have a lack of interest in understanding the importance of a SOP are destine for failure.

    I hate to see people spent time and money starting a business that is destine to fail. My advice is for business people to first sit down and map out what they are doing and where they are going before taking a single step forward. It will make the chances of success 100% better


    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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