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Useful Advices - The Steps from Product Idea to Product Success
Michelangelo once said that his statue of David was embedded in the block of marble and he merely chipped away the edges to reveal it. Is your product idea inside your mind just waiting to come alive? Or, is your product already formed and you need only to smoot
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
h out the edges?
Using my Market-Step process your idea will come to life as we progress in the following steps from idea to launch:
Using my Market-Step process your idea will come to life as we progress in the following steps from idea to launch:
- Self-Evaluation
- Concept Evaluation
- Prototype Evaluation
- Product and Market Planning
- Product Devel
; 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
pment and Marketing Tactics
Product Launch, Marketing and Selling
Please use this roadmap as a navigational tool to guide and monitor your progress. (See www.Product-Coach.com > Articles for a graphical flowchart.)
Getting Started
* Protect Your I
Please use this roadmap as a navigational tool to guide and monitor your progress. (See www.Product-Coach.com > Articles for a graphical flowchart.)
Getting Started
* Protect Your I
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ea (Chapter 4)
When you have an idea, you need to protect it. The first line of defense is to set the date of conception. Start by documenting your idea in an inventor’s notebook, but don’t file a patent until you evaluate its marketability.
Market Resear
When you have an idea, you need to protect it. The first line of defense is to set the date of conception. Start by documenting your idea in an inventor’s notebook, but don’t file a patent until you evaluate its marketability.
Market Resear
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
h and Evaluation
* Self-Evaluation (Chapter 9)
Start the Market-Step process by evaluating your product idea’s marketability. Your product idea is marketable if and when it solves a problem, meets a need or want, overcomes competition, and generates a profi
* Self-Evaluation (Chapter 9)
Start the Market-Step process by evaluating your product idea’s marketability. Your product idea is marketable if and when it solves a problem, meets a need or want, overcomes competition, and generates a profi
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
t.
* Concept Evaluation (Chapter 11)
The second step of the Market-Step process is to determine if people like the concept of your product idea. To test your invention, you’ll need to uncover which people or companies are your future customers. After ident
* Concept Evaluation (Chapter 11)
The second step of the Market-Step process is to determine if people like the concept of your product idea. To test your invention, you’ll need to uncover which people or companies are your future customers. After ident
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
fying potential customers, ask them to evaluate how well your product idea solves a problem, or meets a need or want.
* Prototype Evaluation (Chapter 12)
The third is detailed evaluation by giving people a prototype to examine. A prototype is a working mode
* Prototype Evaluation (Chapter 12)
The third is detailed evaluation by giving people a prototype to examine. A prototype is a working mode
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
that looks, feels, and functions similarly to the finished product. I’ll lead you through the process of creating a prototype that resembles what your customer wants. Then, I’ll show you how to get detailed feedback by interviewing potential customers.
* F
* F
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
nding Your Idea (Appendix F)
Do you need to raise money to develop and market your product? Initially, you’ll need money for expenses such as market research, equipment, and prototype development. Raising money is a normal part of doing business when you sta
Do you need to raise money to develop and market your product? Initially, you’ll need money for expenses such as market research, equipment, and prototype development. Raising money is a normal part of doing business when you sta
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
rt, grow, and expand.
* Patent Review (Chapter 13)
You performed a preliminary patent search earlier. Now it’s worth your time and money to perform a detailed patent search and possibly file for a patent.
* Self-Market or License (Chapter 14)
What do you
* Patent Review (Chapter 13)
You performed a preliminary patent search earlier. Now it’s worth your time and money to perform a detailed patent search and possibly file for a patent.
* Self-Market or License (Chapter 14)
What do you
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
o with your new product? Your choices are to either self-market or license it. In some cases you can do both or sell the rights. Self-marketing means turning your idea into a marketable product that you intend to sell directly to an end-user, and/or through
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
distributor or retailer. Under a licensing agreement, a business will produce and sell your product in exchange for royalties.
Path A: Self-Market Development
If you’ve decided to self-market, follow the remaining steps on Path A. If you’ve decided to lice
Path A: Self-Market Development
If you’ve decided to self-market, follow the remaining steps on Path A. If you’ve decided to lice
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
se your idea, see the next section for Path B.
* Product and Market Plan (Chapter 15)
Plan your work and then work your plan. The fourth step of the Market-Step process involves planning product design and marketing programs. Product design results from com
* Product and Market Plan (Chapter 15)
Plan your work and then work your plan. The fourth step of the Market-Step process involves planning product design and marketing programs. Product design results from com
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
bining your innovation with needs and wants you’ve discovered through research. Market planning involves positioning, pricing, and communications.
* Product and Market Development (Chapter 16)
In the fifth step you’ll develop your product in stages (i.e.,
* Product and Market Development (Chapter 16)
In the fifth step you’ll develop your product in stages (i.e.,
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
lpha, beta, commercial release). You’ll use the beta product to obtain feedback to confirm functionality and eliminate bugs before final production.
* Product Launch, Market and Sell (Chapter 17)
In the sixth step you’re ready to move into production and la
* Product Launch, Market and Sell (Chapter 17)
In the sixth step you’re ready to move into production and la
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
nch your product. This is the most exciting part of your project. You’ve given birth to your idea and are bringing it out into the world. And as you would with a child, you’ll need to nurture and grow your product, with marketing and sales strategies and tac
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
ics.
Path B: Licensing
You’ve determined that licensing is for you. Follow the steps in Path B to license your product idea.
* Licensing Proposal (Chapter 5)
Before approaching a company or product agent, organize your marketing research into a proposal. S
Path B: Licensing
You’ve determined that licensing is for you. Follow the steps in Path B to license your product idea.
* Licensing Proposal (Chapter 5)
Before approaching a company or product agent, organize your marketing research into a proposal. S
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ome companies have their own forms to fill out; others ask to submit in your own format.
If you feel comfortable presenting and negotiating, seek companies on your own to license your product. Otherwise, find product agents who will seek companies and negoti
If you feel comfortable presenting and negotiating, seek companies on your own to license your product. Otherwise, find product agents who will seek companies and negoti
.
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
te on your behalf.
If the company likes what you have, you’ll then negotiate a licensing agreement, then carry out the obligations, and collect royalties.
Going Forward
Now that you have an overview of the steps, my book Product Idea to Product Success,
If the company likes what you have, you’ll then negotiate a licensing agreement, then carry out the obligations, and collect royalties.
Going Forward
Now that you have an overview of the steps, my book Product Idea to Product Success,
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
akes you through the details of the Market-Step process, one step at a time.
* This article can be freely published as long as it is not edited, author information is present, and copyright notice is posted.
Copyright 2004 Matthew Yubas. All rights reserved
* This article can be freely published as long as it is not edited, author information is present, and copyright notice is posted.
Copyright 2004 Matthew Yubas. All rights reserved
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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