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  • Main Subject - Show Me the Money!

    Are you ready to raise money for your startup?

    Leslie Mitts, Managing Practice Leader at the Wharton SBDC and Lead Advisor for the Wharton Venture Initiation Program, tells us that most entrepreneurs coming through her programs are focused on raising capital, even though there are higher priorities in many of their businesses. Since fresh dollars help drive the
    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
    business engine, this is a natural entrepreneurial concern.

    But are you ready to raise money?

    Going to investors before you are really ready can damage your reputation and may actually hinder future funding efforts.

    Team and a Dream uses a unique Fundability Diagnostic to help companies assess their strengths in four key areas:

    Team - This is the most frequen
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    tly cited attribute examined by investors. Many investors will invest in an A-level team and a B-level product, but not the opposite. Having your Seed Team nailed is crucial.

    Traction - Showing momentum is a critical element to demonstrating progress and your ability to execute.

    Perceived Pain - Do people really need your product? Why? Will they need it in the
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    future?

    Product Eco-system - How does your product fit into existing and emerging landscapes? Who else is out there and how big will this market grow?

    Find out what you need to succeed and discover your roadmap to getting there. Take the quiz below to see how well you might expect to score with investors. For each of the four sections outlined above, see which
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    hurdles you can clear given the current state of your business.

    PROCEED WITH CAUTION: Only self-aware entrepreneurs should take these results seriously.

    ASSESSING YOUR TEAM

    Part A:

    If you or any member of your current team are not planning on being the CEO, give yourself two points and proceed to Part B.

    If someone on your team IS planning to continue on as
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    CEO, then you’ll need to answer yes to both of the next two questions in order to score two points; otherwise, take a zero.

    A1. Our CEO has significant, previous management experience in a startup or comparable operating environment (i.e. middle management in a large company doesn’t count!) ( 1 point)

    A2. Our CEO is able to rapidly assess and prioritize our w
    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
    ork with the respect of the team ( 1 point)

    Part B:

    Score one point for each answer.

    B1. Someone on my team has significant experience in the domain space in which we are starting the company ( 1 point)

    B2. Our team understands and acts as if they understand the difference between tasks that are urgent, urgent and important, important, and none of the abov
    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
    e ( 1 point)

    B3. This team has terrific chemistry ( 1 point)

    Your score (0-5) is your Total Team Score.

    If you scored three or more, you pass the Team Hurdle.

    TRACTION

    Score one point for each item you can answer positively.

    1. We have made a few initial sales and have positive indicators from the marketplace for additional sales growth ( 1 point)

    2. So
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    many good things are happening I am bouncing off the walls with excitement ( 1 point)

    3. I have added a significant team member (besides myself!) in the past two months ( 1 point)

    4. In the past two months, I received press coverage that would be acknowledged by my prospects as legitimate business coverage ( 1 point)

    5. We recently have achieved a signific
    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
    ant product or marketplace milestone (includes a single, initial sale) ( 1 point)

    Your score (0-5) is your Total Traction Score.

    If you scored three or more, you pass the Traction Hurdle.

    PERCEIVED PAIN

    Award your Team the number of points indicated after each question that you answer positively.

    1. My product or service solves an important problem for a we
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    l defined group of people ( 2 points)

    2. My product or service will be in great demand in the future in order to solve problems emerging from a new trend that has a large population of prospects ( 2 points)

    3. My product or service takes advantage of newly available market forces (technology, demographics, societal). The result is an offering that will clea
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    rly appeal to an existing, well-known market demographic ( 1 point)

    Your score (0-5) is your Total Perceived Pain Score.

    If you scored three or more, you pass the Perceived Pain Hurdle.

    PRODUCT ECO-SYSTEM

    Score the stated number of points for each item you can answer positively.

    1. My product is unique in a clearly defined (i.e. I can describe the differenc
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    e in one or two clear sentences) and useful way ( 1 point)

    2. My product is patented or can easily be patented or I have another competitive barrier (e.g. trade secret, unique manufacturing process, etc.) that will make it difficult for others to compete directly ( 1 point)

    3. My marketplace is well established but fragmented or my product has “category kill
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    er” potential because it is so unique to the market ( 1 point)

    4. My marketplace is either very big (> $5 billion/year in sales) with clear room for a product like mine or is rapidly growing with well documented trend lines ( 1 point)

    5. My marketplace is wide open and there are no competitors ( subtract 1 point)

    Your score of (-1 to 4) is your Total Product
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    Eco-System Score.

    If you scored three or more, you pass the Product Eco-System Hurdle.

    Now that you have completed the scoring, we shall take a look at how “fundable” your company is. Before we do, it’s important to realize that this is a snapshot in time. If you are not satisfied with your score, there are plenty of things you can do to improve it. I’ve se
    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
    n many of my clients make tremendous progress along these dimensions by extending their team, focusing on sales or tweaking their offering.

    YOUR FUNDABILITY RATING:

    Number of Hurdles Cleared: None

    IMPLICATION

    If you received this score and hope to receive funding, then you have a lot of work to do. Perhaps you just know you want to start a business and are
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    looking for ideas. If so, keep these criteria in mind as you formulate your plans.

    If you already have a business concept, you should think long and hard about “re-conceiving” some elements of it to improve your scores.

    Many perfectly good “lifestyle” businesses may fall into this scale – you just can’t get funding for them.

    Number of Hurdles Cleared: One

    I
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    MPLICATION

    Funding from your rich uncle may be possible

    Number of Hurdles Cleared: two

    IMPLICATION

    Funding from family and friends network may be possible

    Number of Hurdles Cleared: three

    IMPLICATION

    Professional investors will consider this, but you’ll need to be prepared to explain how you’ll address your gaps.

    Number of Hurdles Cleared: all four

    IMPLI
    .

    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
    CATION

    Put the finishing touches on your business plan and hit the funding trail!

    You will have the best chances of success in fund-raising if investors see that you can clear the hurdles in all four areas.

    NOTE: Team and a Dream offers a professional version of this assessment that offers additional detail and examines nuances that aren’t possible to convey i
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    n a simple quiz. If you have an interest in the professional assessment, please visit us at http://www.teamandadream.com/contactus.htm

    Contact Information:
    http://www.teamandadream.com
    skip@teamandadream.com

    Copyright (c) 2005, All rights reserved by Post Destiny, Inc. d/b/a Team and a Dream(SM


    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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