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Rapid prototyping is the method of constructing physical objects using solid freeform fabrication. The use of rapid prot

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

otyping techniques had its start during the 1980's where it was used to build product models. Its current applications h

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

Examples of combination products may in

ave been put into use in a wider range of objectives.

The technique can even be used in order to manufacture quality us

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

able parts in small numbers. Rapid prototyping has even found some applications in the art scene where sculptors use the

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

technology to create intricate shapes that become art pieces.

An improved digital rapid prototyping system makes use o

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

Combination pro

computers in order to create highly accurate design pieces. A digital rapid prototyping system makes use of virtual des

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

igns usually created with the help of computer aided design or animation modeling software programs.

The system then tr

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

nsforms the design into virtual cross sections which a special machine uses to recreate the exact design cross sections

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

in physical space until a physical model is finished. The highly technical process enables virtual designs to take physi

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

al shape in very exact and accurate manner.

In rapid prototyping, there are usually two basic approaches to design syst

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ems being used. The approach chosen can either be formative or summative. The formative approach is being used for situa

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

tions wherein the prototype is first built based on the current stage of the design. It is then tested on a control grou

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

with the results being used to integrate into the next stage of development in order to further enhance and improve on

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

the usefulness of the current design.

The summative approach on the other hand takes a different course in developing p

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

oduct design. A single test exercise is performed at the end of the overall design enhancing process. At most times the

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

approach is a two step stage. Following the summative approach can sometimes make it too costly to make design changes a

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

the end stage nears.

But this approach is less time consuming and can be more cost effective initially if the projecte

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

d design is seen to require little refinements when a prototype is done. But in the long run, using the formative approa

.

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

h will definitely be more beneficial. The main reason for this is because when a system is tested as a whole only once a

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

t the end of the design period, it may be very difficult to pin point the various flaws that may exist within the design

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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