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Main Subject - How To Get Started With Your First Invention
So, a little light bulb inside you head has lit up and you are struck with the idea that you invented something. You are not sure yet how practical your idea is at this time, but something
tells you that this might be the Big break you were looking for. What you do next and how you approach your next steps is extremely important and will either lead you on to glory or will
doom your undertaking. The steps that I will outline a little later might seem unnecessary; however I want to assure you that in the end you will be happy that you
took my advice.
Before we proceed with the discussion, I would like to offer a few words of wisdom. While working on your idea you will encounter people who will criticize your work and try to discourage yo
Before we proceed with the discussion, I would like to offer a few words of wisdom. While working on your idea you will encounter people who will criticize your work and try to discourage yo
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
u
from forging ahead. Some of the criticism will be deserved and should be taken into account. If you see that a valid point is raised that you never thought of before -
the better off you are. It gives you opportunity to pause and view your idea from another perspective (or angle). However, you may also encounter a so-called destructive criticism that is not based on any facts.
When you learn how to separate these two, you will be better of. My advice to you -
- Don't be afraid to question professionals, because most experts are one-track minded and oblivious to other things
- Don't be afraid to challenge other people's ideas, stand by your principles and be firm
- Don't be afraid to discover that your own idea is faulty. Pause,
When you learn how to separate these two, you will be better of. My advice to you -
- Don't be afraid to question professionals, because most experts are one-track minded and oblivious to other things
- Don't be afraid to challenge other people's ideas, stand by your principles and be firm
- Don't be afraid to discover that your own idea is faulty. Pause,
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
make corrections, re-analyze and move ahead
When you are ready to market your idea, you will have to deal with large corporations. Keep in mind that the bigger the company is, the more bureaucratic it is. Many big companies lose focus and often hire employees who are either not qualified for the job, or just not interested in what they are doing. If you come across these folks who are trying to make you feel insignificant (and your idea unimportant and impractical) don't get discouraged by this - chances are you will be better off dealing with smaller company that is more focused and willing to take risks!
Step 1 - Stay Focused and Clearly Document Your Idea
This step has huge benefits, because –
1. You will clearly define your idea/inve
When you are ready to market your idea, you will have to deal with large corporations. Keep in mind that the bigger the company is, the more bureaucratic it is. Many big companies lose focus and often hire employees who are either not qualified for the job, or just not interested in what they are doing. If you come across these folks who are trying to make you feel insignificant (and your idea unimportant and impractical) don't get discouraged by this - chances are you will be better off dealing with smaller company that is more focused and willing to take risks!
Step 1 - Stay Focused and Clearly Document Your Idea
This step has huge benefits, because –
1. You will clearly define your idea/inve
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ntion
2. While documenting your idea, you may find ways on how to expand your invention
Always try to put on paper what it is that you invented - precisely define your idea, its purpose, limitations and target audience. If you cannot precisely define your idea, then this means that you should take a step back, re-analyze your thinking and simplify things. The most common error that people make at this stage is over-complicating their idea. A quick example will clarify this point:
Case Study 1
John K. has an idea on how to improve Automatic Knife Mechanism. While laboring hard on his invention, John K. produces technical drawings and decides that his future product will benefit from the addition of extra items – a scissor and a screw drive
Always try to put on paper what it is that you invented - precisely define your idea, its purpose, limitations and target audience. If you cannot precisely define your idea, then this means that you should take a step back, re-analyze your thinking and simplify things. The most common error that people make at this stage is over-complicating their idea. A quick example will clarify this point:
Case Study 1
John K. has an idea on how to improve Automatic Knife Mechanism. While laboring hard on his invention, John K. produces technical drawings and decides that his future product will benefit from the addition of extra items – a scissor and a screw drive
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
. However, the addition of these items makes the final product larger and heavier. In order to make knife lighter, John K. goes back to the drawing board – he compromises his original, Automatic Push/Pull mechanism design in attempt to accommodate unnecessary extra features that have nothing to do with his unique design. By taking away features from his original design, John K. makes his final design very pedestrian and it lacks in originality.
In the final analysis, John K. should have stopped right before making any changes to his original Automatic Knife Mechanism and asked himself the following – am I better off with the original mechanism or with pedestrian mechanism which has extra features? Are the extra features even necessary?
The
In the final analysis, John K. should have stopped right before making any changes to his original Automatic Knife Mechanism and asked himself the following – am I better off with the original mechanism or with pedestrian mechanism which has extra features? Are the extra features even necessary?
The
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
above example clearly illustrates the following – focus on your original idea and ignore additional, superfluous features that might muddle your vision. Extra features will come into play later, once you clearly described and shaped your invention.
Step 2 Exploratory Stages – Determine if your idea is unique
Once you’ve documented your idea, you should start thinking about the following – how unique is my idea? In order to answer these questions, you will have to do some legwork and hit your local library and internet. Unless you allocated a large amount of your budget to Patent Lawyers, who will do the research for you, you will be better off doing initial research by yourself. Why? Because you may discover during your exploratory searches
Step 2 Exploratory Stages – Determine if your idea is unique
Once you’ve documented your idea, you should start thinking about the following – how unique is my idea? In order to answer these questions, you will have to do some legwork and hit your local library and internet. Unless you allocated a large amount of your budget to Patent Lawyers, who will do the research for you, you will be better off doing initial research by yourself. Why? Because you may discover during your exploratory searches
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
that your design is not unique and save yourself from paying Big Lawyer fees. A note of caution – don’t get discouraged if you determine that the idea similar to yours already exists and already patented. The fact that someone came to the similar conclusions as you, just a little bit earlier is good – you have a competition! Competition is good, competition is healthy! Carefully examine competing product, even take it apart, if necessary. Determine what differentiates your idea from competitor’s, its limitations and how successful was another person (or a company) with marketing it. As you can see, you can actually learn from mistakes of others, avoid their mistakes and forge ahead fully aware of competition and their limitations.
Step 3 -
Step 3 -
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
roduct Safety Considerations
Whether you decided to produce a baby product or some type of household appliance, a special care should be taken in describing potential hazards associated with the use of your product. For example, if you invented a new toy designed for small children, try to come up with the list of parts that can potentially harm your little customers. Keep in mind that many people, unfortunately, disregard exploitation manuals. Determine what can or may go wrong with the operation of your product and determine ways on how to improve product safety. The questions that you may ask yourself are the following –
1. Am I using proper materials? 2. Maybe the part that contains the most hazards should be redesigned?
Try to come u
Whether you decided to produce a baby product or some type of household appliance, a special care should be taken in describing potential hazards associated with the use of your product. For example, if you invented a new toy designed for small children, try to come up with the list of parts that can potentially harm your little customers. Keep in mind that many people, unfortunately, disregard exploitation manuals. Determine what can or may go wrong with the operation of your product and determine ways on how to improve product safety. The questions that you may ask yourself are the following –
1. Am I using proper materials? 2. Maybe the part that contains the most hazards should be redesigned?
Try to come u
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
p with a thorough list of parts that can be potentially hazardous and fix your design before you start marketing your product. You may think of this step as unnecessary, but let me warn you – most marketing companies will require you to describe all Safety features of your idea, and you might save yourself some time by doing preparations ahead of time.
Step 4 - Demographics and Determining who will Use Your Product
Ones you have a clear picture of your product and you worked out all nuances of product design, try to determine who will use your product, when and where. Try to ask yourself the following questions –
1. What is the age bracket of target audience? 2. Is my product designed for Men, Women, or Both? 3. Where and when can it be
Step 4 - Demographics and Determining who will Use Your Product
Ones you have a clear picture of your product and you worked out all nuances of product design, try to determine who will use your product, when and where. Try to ask yourself the following questions –
1. What is the age bracket of target audience? 2. Is my product designed for Men, Women, or Both? 3. Where and when can it be
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
used?
Correctly answering these questions will help you properly market your product and stay abreast of the competition. In addition, knowing answers to the above mentioned questions will help you in putting finishing touches on your product. How? If your product is designed for children, then it should be bright and colorful. In addition, if your product is designed for cold climate, you should avoid marketing it in areas where it’s hot all year long.
It is very likely that your product is tailored for certain industry (for example, agricultural); then think of those who will benefit the most from your invention! If your product is designed to work with specific soil or crops, then you should target geographical region rich with desired c
Correctly answering these questions will help you properly market your product and stay abreast of the competition. In addition, knowing answers to the above mentioned questions will help you in putting finishing touches on your product. How? If your product is designed for children, then it should be bright and colorful. In addition, if your product is designed for cold climate, you should avoid marketing it in areas where it’s hot all year long.
It is very likely that your product is tailored for certain industry (for example, agricultural); then think of those who will benefit the most from your invention! If your product is designed to work with specific soil or crops, then you should target geographical region rich with desired c
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
aracteristics. As one can see, this step requires a thorough research, planning and leg work; the benefits, on the other hand, will be payoff rewarding!
Step 5 – Produce Full or Small Scale Model of Your Product
It is extremely important to create a working model off of your idea. Why? By having a real-life model of your idea (or a scaled-down version of it), will help you to -
1. Identify its limitations and gives you a chance to re-think some aspects of your initial design and make necessary corrections 2. Enhance your final design
In addition to the above mentioned items, the final model will help you psychologically. There is no better feeling then to be able to physically see and touch the creation of your own mind! The fact that yo
Step 5 – Produce Full or Small Scale Model of Your Product
It is extremely important to create a working model off of your idea. Why? By having a real-life model of your idea (or a scaled-down version of it), will help you to -
1. Identify its limitations and gives you a chance to re-think some aspects of your initial design and make necessary corrections 2. Enhance your final design
In addition to the above mentioned items, the final model will help you psychologically. There is no better feeling then to be able to physically see and touch the creation of your own mind! The fact that yo
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
u are touching the real-life model of your final design will give you positive psychological boost equal to no other you’ve experienced during design process, motivating you even more to succeed!
The best way to approach this step is to try and draw on a piece of paper the final version of your product, the way you see it at this point in time. Your drawings should show your final idea/product under different angles, in a 2-D and 3-D. The picture might not be pretty because not many of us have the necessary drawing skills. However, this drawing task will help you immensely solidify your design and pin-point items that you still need to work on. In addition, I strongly recommend that you generate your initial product prototype from clay or an
The best way to approach this step is to try and draw on a piece of paper the final version of your product, the way you see it at this point in time. Your drawings should show your final idea/product under different angles, in a 2-D and 3-D. The picture might not be pretty because not many of us have the necessary drawing skills. However, this drawing task will help you immensely solidify your design and pin-point items that you still need to work on. In addition, I strongly recommend that you generate your initial product prototype from clay or an
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
y other material that is readily available. Why? Because this prototype along with initial drawing will help you explain your idea to technical person who, in turn, will transform your design into highly technical engineering drawing.
Once you prepared your model, try to determine what materials will go in into construction of real-life product. Will your product be build of plaster or metal? If metal, then what kind of metal – is it aluminum, copper or some type of alloy? Once you determined the necessary materials, estimate production cost because the price that you’ll charge for your product will depend on the production cost of each individual unit. You don’t have to be 100% correct at this stage with your material selections, but it’s v
Once you prepared your model, try to determine what materials will go in into construction of real-life product. Will your product be build of plaster or metal? If metal, then what kind of metal – is it aluminum, copper or some type of alloy? Once you determined the necessary materials, estimate production cost because the price that you’ll charge for your product will depend on the production cost of each individual unit. You don’t have to be 100% correct at this stage with your material selections, but it’s v
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ery good to know what materials will go into production of your product so that you have a ball-park figure on the final cost of your product.
Step 6 – Estimate Cost and Gross Profit
Once you determined who will use your product and where (or your product’s market), it is time to think “big” – try to work out cost/benefit analysis of your product. Below is a case study –
Mary A., a homemaker with three little children, designed a plastic bottle holder for babies and small toddlers. Her bottle holder was designed in such a way that it would hold both the bottles, spoons and bottle caps. Mary A. created numerous drawings of her product and with the help of her husband managed to produce a full-scale version of her product made of clay. Befor
Step 6 – Estimate Cost and Gross Profit
Once you determined who will use your product and where (or your product’s market), it is time to think “big” – try to work out cost/benefit analysis of your product. Below is a case study –
Mary A., a homemaker with three little children, designed a plastic bottle holder for babies and small toddlers. Her bottle holder was designed in such a way that it would hold both the bottles, spoons and bottle caps. Mary A. created numerous drawings of her product and with the help of her husband managed to produce a full-scale version of her product made of clay. Befor
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
involving an engineer, Mary A. estimated that her product will be made entirely out of plastic. The estimated production cost of 1 bottle holder is $3.00 (we presume that the manufacturing plant is located in China and shipping costs are already factored in into the estimated production cost). Mary A. did comparative shopping and determined that other types of Baby Holders are selling around $15 dollars. In addition, Mary found out that three local baby stores each serve 1000 shoppers per day (including online purchases); in addition, each stores requires a 40% commissions per each purchase - meaning that $6 is paid as a commission to the store for each $15 purchase. Mary A. immediately figured out that her total profit will be $6 per each b
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
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
ottle holder ($15 - $6 - $3). Presume that one third of all shoppers in each store have either babies or toddlers who still need bottle holders (approximately 330 consumers per store), Mary A. can generate profit in the amount of 330 X 3 X 6 = $5940.
Step 7 – Product Marketing
Correct marketing strategy is absolutely essential to the success of your idea. Partnering with marketing company that you can trust and rely upon will pay big dividends in the long run and should not be overlooked. What should you know about marketing companies? Most of these companies are divided into two groups (I will call them groups A and B) –
1. Group A: These companies claim that they have specific knowledge and inside connections in a broad range of industri
Step 7 – Product Marketing
Correct marketing strategy is absolutely essential to the success of your idea. Partnering with marketing company that you can trust and rely upon will pay big dividends in the long run and should not be overlooked. What should you know about marketing companies? Most of these companies are divided into two groups (I will call them groups A and B) –
1. Group A: These companies claim that they have specific knowledge and inside connections in a broad range of industri
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
es. In addition to been expensive, many companies that belong to this group are accused of fraud and inventor should carefully consider who they are dealing with. In the best case scenario, you could potentially lose all your money and valuable time; in worst-case scenario, in addition to losing money someone else may benefit from your invention (unless, of course, you were lucky enough to patent it!!)
2. Group B: These companies give inventor complete freedom in marketing their idea. Inventors choose what to say and focus on emphasize areas that they think are most pertinent to their invention. I would like to point out IdeaJets website (www.ideajets.com): IdeaJets is a marketplace where people with ideas and companies who search for sharp
2. Group B: These companies give inventor complete freedom in marketing their idea. Inventors choose what to say and focus on emphasize areas that they think are most pertinent to their invention. I would like to point out IdeaJets website (www.ideajets.com): IdeaJets is a marketplace where people with ideas and companies who search for sharp
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
minds meet. In addition to helping you find a right partner who can help you realize your ideas and dreams, IdeaJets also brings inventors in contact with other ambitious people to cultivate and promote the culture of inventiveness and success. You can meet your fellow inventors using IdeaJets messaging system or in Forums. Hopefully, by sharing ideas and opinions, users might view their inventions or ideas in a new light, refine and re-define them to further increase their chances to succeed. As of right now, IdeaJets is completely free!
Conclusion and some Final Thoughts:
As one can see, it takes a lot of patience, preparation and perseverance on behalf of inventor to succeed. The main thing is to not get discouraged by the presence of co
Conclusion and some Final Thoughts:
As one can see, it takes a lot of patience, preparation and perseverance on behalf of inventor to succeed. The main thing is to not get discouraged by the presence of co
.
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
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
mpetition and potential rejections. As I mentioned in my article, competition is good and healthy. If your competitor is enjoying a great success with the product similar to what you’ve developed, then this means that the product that you are working on has great potential. Carefully examine competitor’s product and determine its weaknesses or vulnerabilities. This, of course, presumes that you finalized your initial design, worked out all the kinks and produced a full-scale (or scaled-down) version of your product. Once you know enough about competitor’s product, carefully study your market and demographics - this will help you in designing marketing strategy specifically tailored towards your product. Put on paper and document all your find
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ings because you may forget some details later on and realize that the data you painfully need is gone. In general, try to incorporate all your findings related to cost, market and demographic analysis into Business Plan and store it in a safe place! Most companies you will try to work or partner with will require you to produce Business Plan documentation. Not having one will force you to produce Business Plan documentation almost overnight and this is not an easy task. My suggestion to you - start working on the Business Plan from the very beginning and save yourself from having sleepless nights! And a final word of wisdom – don’t be afraid to be over-confident, because confidence and belief in one's own powers are a great recipe to success
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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