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  • Main Subject - Avoid These Seven Deadly Dangers Of Outsourcing

    Here are seven dangers of outsourcing your software development. They become deadly if your career or entire company depends on the timely release of your software.

    Danger #1- Ignoring
    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
    Outsourcing It may seem safer to ignore outsourcing and stick with what has worked well in the past -- hire employee programmers and work with them directly to get your software develop
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    d. There are situations where concerns about intellectual property or security make this the only choice. But if you do not have these constraints, then you are wasting money and time by
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    hiring your own programmers.

    Danger #2- Hiring the Wrong Team It is a common mistake to look for an outsourcing vendor only in your immediate circle of friends and acquaintances. Cons
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    dering ONLY your friend's roommate's brother in Bangalore, or his cousin in Kiev, is unlikely to provide you the outsourcing vendor that best matches your software development needs.

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

    Combination pro
    n't hire an outsourcing vendor that will be distracted by developing their own products. The best teams are dedicated to providing software development services for their clients and alr
    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
    ady have multiple happy clients in the US.

    Danger #3- Not Protecting Your Intellectual Property The dangers of not protecting your intellectual property (IP) are multiplied when workin
    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
    g with outsourcing. Are you using all three types of IP protection - physical, electronic and legal?

    Make sure your outsourcing vendor has a secure facility and uses computers without r
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    movable media to reduce the risk of unauthorized access to your IP. Use firewalls, VPN and encryption to protect your IP when in transit over the Internet. Use proper legal protections
    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
    including written agreements and NDAs that are enforceable in the US. A clearly stated contract helps avoid disagreements later and keeps you from the expense of litigation.

    Danger #4-
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    Not Knowing What Your Software Should Do Having good requirements and specifications are key to successful software development, and especially for outsourcing. Fortunately, outsourcing
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    can be successful with only a high-level specification and an outsourced team that can collaborate and communicate with you to determine the details.

    Danger #5- Meager Engineering Mana
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ement Unfortunately, you cannot completely rely on an offshore team to manage your software development. They will do their best to meet commitments to schedules and a high level of qua
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    lity. You can outsource the programming but not all the responsibility for creating great software.

    Danger #6- Mediocre Software Development Methodology How do you go about the process
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    of developing software? Do you create an excruciatingly detailed spec and then micromanage? Do you pile up the features for a single stupendous major release? And do you make sure the of
    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
    fshore team must cram all those features in the software by next Tuesday? If so, you have a mediocre software development methodology.

    Do you assume "No News is Good News", if you have
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ot heard from your offshore team? Do you NOT have a standard software release procedure or source code control system? If so, you have a mediocre software development methodology.

    Dange
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    r #7- Quality as an Afterthought QA is a critical part of the software development process. It is also a major concern when you outsource to programmers that are far away. You cannot wa
    .

    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 to start testing until just before you release your software and rush an unacceptable version into use. Having your users find the bugs is a bad strategy.

    ***

    You don't need to repea
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    t the mistakes of other companies that have tried outsourcing and failed. Avoid these seven deadly dangers take advantage of outsourcing as an effective strategy to develop your software


    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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