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    First I must explain my experiences. This article comes on the eve of the release of a web site my company and I have been diligently working on for the past year. During the year we went from developing the project in house to outsourcing it to two different teams in India, until finally deciding to bring the project back in house. Rather than focus on the entire development process I thought it would be a good opportunity to explain my experiences with outsourcing, particularly o
    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
    utsourcing to companies in India and how to best do so.

    Who this article is for:

    • Companies or individuals wanting to develop a web project or application at minimal cost
    • Companies or individuals investigating the various ways of developing a web project or application
    • Companies or individuals currently developing with an outsourced foreign team in India or other non-native country

    Outsourcing Is Hard and Takes Tie

    What you must
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    first realize that outsourcing is hard and takes time. There are certain sacrifices that are inherently made when you outsource a project overseas. These sacrifices include communication issues, timing issues, and language issues.

    Outsourcing to an outside party, another company or individual is incredibly hard. Typically the concerns include security and accountability. Unlike an employee, who is expecting a paycheck each week company’s responsible for outsourced projects may hav
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    a number of other “employers” or benefactors. You are almost never their only source of income. Will they complete your project on time? Will they deliver for the quoted price? Will communication be a problem?

    What are the problems associated with outsourcing?

    The four major reasons outsourcing is difficult:

    • Communcation
    • Security
    • Technical Skill
    • Price

    Recently we had an in house project we wanted to develop. We used the project as a prac
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ice tool for some contacts in India. It was the perfect test project. Its complexity and depth as well as the fact that it was completely internal (we had no client deadlines to meet) would made it a perfect tool to test these Indian developers. Unfortunately, it was a complete failure. After two separate seemingly established companies failed to develop the site we had to take it back inside and finish it ourselves.

    Why Does Outsourcing (Usually) Not Work?

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

    Combination pro
    e back I attended a fantastic seminar on business growth and development. I was there mostly for networking opportunities, but was able to learn a great deal from the presenters. One of the contacts I made was an upstart IP telephony company. The upstart wanted my company to manage his team of developers in India, they would hand off projects to my company, we would feed it to the team and they would output the work. Ultimately we were responsible for the output. What would we get
    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
    n return? What would be our compensation for managing this team in India? Access to their resources for $10/hour. We could use the team as we wished to do most or all of our work.

    After viewing some of the code of the Indian company in question we decided to decline the offer. Until recently it was a decision I was still unsure of. But, in hindsight, after the events of this most recent project, I believe we made the right decision. Communication

    Why is outsourcing so difficult?
    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
    The biggest reason is typically communication. First, in my case the company and individuals I dealt with were not from America, they were from India, and their first language was not English. This presented a number of problems throughout the progress of the project. As we do with most projects, we created a number of guidelines and objections for the project including look, usability, and maps. A great deal of time was spent via chat client explaining and expanding on certain id
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    as and routes in order to allow the developers to begin developing, a task that is not as time consuming or more straight forward when dealing with a more native team. Certain words and phrases had to be removed or revised to avoid confusion, but even after doing so, the product we received was not what we had requested. Instead the product we received was a mutated mess of what we had originally requested.

    I was interviewing a potential client the other day that had had a simila
    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
    problem. She came to our conference table and plunked down pages and pages of beautiful diagrams and text on the content of the system she wanted built. It was a dream come true. Everything was sectioned off, user interaction was mapped and diagrammed, the flow of the sections and modules of the sites was illustrated, this was the perfect client. The poor woman then went on to describe how she had paid a developer $500 to produce a system. After communication issues she spent hour
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    developing these documents in order to facilitate the system’s production.

    After months of coding and back-and-forth the system was never finished. The developer collected his $500, but my client had a half finished system that was poorly coded, poorly designed, and she had done most of the work! Now I don’t think she was totally screwed (she did receive A LOT for her money), but, she was quoted $500 for a full system, a full system that was never provided. In terms of communica
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    tion you have to ask yourself:

    • Am I ready to spend the extra time it takes to use a foreign developer?
    • Am I technically savvy enough to make the types of requests I need to make when dealing with a foreign developer in terms of communication?
    • Is my extra time better spent on my own work?

    Other communication issues such as time and means also arise. What is the time difference between you and your developers? We often have difficulty working with clients on the Wes
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    Coast because of a 3 hour time difference. What happens when your developers are 12 hours ahead of you? It’s 3pm here, but are your developers up and working, ready for a conversation about your system at 3 am, or vice versa? Are you willing to stay up extra late just to communicate with your team in India? Finally means of communication can also be an issue. IMs and chatting is a great tool for quick communication, but often meaning or connotation can get lost or misconstrued wh
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    n sent through this means. Phone calls can be incredibly expensive quickly adding to the bottom-line of your project.

    Security

    Security is probably the second most important issue to consider when developing with an overseas developer. Not only security in terms of money, how you will provide payment, and they will provide work, but also intellectual property issues, have you worked out who owns the code you are developing?

    You must also make sure that you are i
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    full control and can change and of the resources your developer must access in order to do work. Are you ready and capable of changing FTP information, database names, usernames and passwords? This will all help once the project is complete and you are ready to take your finished product.

    Finally another major concern is developers stealing ideas. Have you worked out some kind of agreement that your ideas or the system you’ve described to your developer is your intellectual prope
    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
    ty and that they are not allowed to try to duplicate or replicate in any way before, during, or after development?

    Technical Skill

    One of the major reasons I have been hesitant to use Indian, or any other foreign developers, so far is because of the level or quality of their work. I have seen some great programmers, but in terms of my personal preferences for standards based, XHTML & CSS web sites, none have yet met my level of satisfaction.

    Can you say the same
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    of your developers? Do you, or someone at your organization have the skills or know-how to evaluate the quality (not just the appearance) of the coding your developers provide?

    Price

    The third and final factor is price. Price is the reason your outsourcing or considering outsourcing in the beginning right? Well scope creep is a large problem when dealing with foreign outsourced developers. To avoid scope creep you must plan and detail everything. Do you have the
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ime or want to plan/detail everything? Is your time better spent more profitable somewhere else? If you bill your own time at $90/hour and spend 100+ hours developing incredibly detailed, intricate plans, and spend additional time communicating and re-communicating to your developers are you using your time efficiently?

    Now you may have found a very talented, capable team or individual across the spans of ocean and land to do your work for you. I don’t argue that some great compan
    .

    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
    ’s do exist. I also am not arguing that the level of work or the talent of the individuals is not great. I must say though that the biggest problem with outsourcing, the reason it does not work on a small scale is COMMUNICATION!

    Communication, that stupid word that kept creeping up in all of my freshman required courses. Communication, the #1 failure of most businesses, both internally and in client relationships, is the reason outsourcing does not work.

    Despite all of this outso
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    rcing can and does work. In fact, right now we are working with a fantastic company in India that has been efficient, easy to communicate with, and thorough. We have established checksums and procedures based on the same things I just talked about in order to facilitate this symbiotic relationship. Another key thing to point out, they are much more expensive than the original few companies we hired for our other projects. So the old axiom really is true, you do get what you pay for


    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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