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Advice You - I Have An Idea For A New Product, But Now What?
Do you have an idea for an electronic product, the next must-have gadget, music or video system, time saver, or the greatest problem-solving device that was ever invented? Before you begin designing the product, there are a number of tasks that you must complete and issues that you must resolve before you have an ac
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
tual product design that can be produced, marketed, and sold. This article will provide you with some guidelines to assist you in getting your idea turned into a successful design. Other issues, such as whether or not to apply for a patent for your product idea and in detail how a particular product should be adver
; 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
tised or marketed will not be addressed in this article.
Many great product ideas were turned into fully functional electronic devices but never made their way successfully to the marketplace because the product was not easy to use, the target market or niche market where the product could be sold successfully was n
Many great product ideas were turned into fully functional electronic devices but never made their way successfully to the marketplace because the product was not easy to use, the target market or niche market where the product could be sold successfully was n
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ot accurately identified or targeted, the product advertising was not successful, an unattractive or non-identifiable name was applied to the product, the product pricing was too expensive, the product was provided in unattractive packaging, the product as manufactured was unreliable, or the wrong sales distribution
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
model was chosen. There are a lot of minefields to dance in before you have a successful product that meets or exceeds your sales expectations.
Initially you must identify the following to determine if your product idea is valid:
- who would buy this new product?
- how much would they be willing to pay fo
Initially you must identify the following to determine if your product idea is valid:
- who would buy this new product?
- how much would they be willing to pay fo
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
it?
- can you produce the product and make the required profit margins at the anticipated sales price?
- how do you get the product in front of the customers so that they can buy the product? - can you provide warranty and service functions for the product?
- will your design require product complian
- can you produce the product and make the required profit margins at the anticipated sales price?
- how do you get the product in front of the customers so that they can buy the product? - can you provide warranty and service functions for the product?
- will your design require product complian
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
ce testing for any applicable FCC or UL regulations?
- will the product have to meet RoHS requirements (such as lead-free for components and soldering) for overseas (European Union, China, Japan, Korea, etc.) and domestic (California) markets?
- would this product infringe on any existing patents?
To a
- will the product have to meet RoHS requirements (such as lead-free for components and soldering) for overseas (European Union, China, Japan, Korea, etc.) and domestic (California) markets?
- would this product infringe on any existing patents?
To a
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
nswer the above questions, you should document your product idea in the form of a product specification document that describes which systems that the product could interface with. It should also identify all of the various functions the product should perform, describe how the product should be packaged estheticall
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
y and physically for size and shape, and define how the device will be powered. The product specification document should also describe how the user would interface with the product, such as by an equipped keypad, pushbuttons, a rotary dial switch, touchscreen, by an external link to a personal computer, PDA, or one
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
of the newer sophisticated cell phones. You must also consider how the unit will display information to the user with options including an LCD character display, light emitting diodes or LEDs either singly or in an array, a graphics capable display in monochrome or color, or by audible tones.
Once the initial prod
Once the initial prod
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ct specification document is completed, a marketing study should be initiated that identifies the optimum target market or market niche, and the product's preferable name choices, including a primary name choice and some alternate name choices. The marketing study should provide options for selling the product both
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
directly and through sales distribution, including who would actually stock, sell, and support the product in each scenario. The marketing study should also include the product's anticipated pricing range such as the anticipated MSRP or manufacturers suggested retail price at the upper end and the discounted pricing
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
where you would really be able to sell large quantities of the product at different volume levels and different margin levels at the lower end.
When the marketing study is completed, it should be reviewed against the original product specification document and changes made as required to either or both documents to
When the marketing study is completed, it should be reviewed against the original product specification document and changes made as required to either or both documents to
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
fully identify the product requirements. Once this review is completed, the electronics and mechanical packaging design processes can begin, based on the parameters established by the review of the product specification document and the results of the marketing study. In order to optimize the design, the product d
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
esigners must know what functions the product should perform, what the product should look like, and how much the product should cost to be manufactured and packaged ready for sale. Product logo designs and product labeling requirements should also be identified as they can have an impact on the physical package des
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
gns and the overall appearance of the product.
With this information available, you are now prepared to either design the product yourself; utilize other internal resources to design the product, or to contract the design activities with an outside source. You will need access to the following functional skill sets
With this information available, you are now prepared to either design the product yourself; utilize other internal resources to design the product, or to contract the design activities with an outside source. You will need access to the following functional skill sets
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
to have your idea turned into a working product:
- electronics hardware designer(s) with the analog and/or digital design expertise required for your design idea application - printed circuit board layout designer with an applicable pcb CAD package - a software designer with the required programming expertise a
- electronics hardware designer(s) with the analog and/or digital design expertise required for your design idea application - printed circuit board layout designer with an applicable pcb CAD package - a software designer with the required programming expertise a
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
nd software tools
- a mechanical packaging specialist
- an electronics assembly resource to populate the printed circuit boards, to solder the components to the boards, and to assemble the finished prototype product
Even if all of these resources are available within your own company, they may not be available to
Even if all of these resources are available within your own company, they may not be available to
.
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
you in the timeframe your product introduction requires due to scheduling conflicts with other internal projects. This is the point in the project where it can make economic and scheduling sense to make use of the resources from outside entities. Sometimes all of these resources can be outsourced from an electronic
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
s manufacturing service provider or EMS, or you may find an engineering resource to provide the initial design services and an EMS to assemble the product. Be sure to have an appropriate Non-Disclosure Agreement in place with any and all parties that are involved in this process to protect your intellectual property
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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