Advice You - Business

Manufacturing technologies have advanced geometrically over the past twenty years. A

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

nd rapid prototyping techniques have grown even faster. In all most every process th

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

Examples of combination products may in

at is used to make components, a complimentary process has been developed to make prot

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

otypes and short production runs.

Aluminum die casting has been the process of choice

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

for the majority of high volume applications for decades. Volumes need to exceed 50,0

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

Combination pro

00 pieces per year. So what if you have a new product that you want to launch with 5,

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

000 units and it involves several aluminum castings per product?

Is there a way to pr

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

duce these components on a limited tooling budget?

Fortunately there are numerous pr

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

ocesses for producing prototype and low volume precision castings. Several of the pro

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

cesses are:

1) Plaster Mold Casting

2) Graphite Mold Casting

3) V-Process Casting

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

hat are the advantages of these processes? Precision castings that simulate the die c

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

Following aspects would a

asting method can be produced for a fraction of the upfront(tooling) costs required fo

dd to the challenges in developing combination products:

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

r die casting. Plus these methods have high volume production capabilities. All of t

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

he processes are capable of producing 100 units and then with the same tooling, can be

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

ramped up to higher volume of 2,000 to 5,000 piece production runs.

These methods are

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

also fast. Castings can be produced in 1-2 weeks if necessary.

These precision cast

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

Professional from academic institutions, pharmaceutical industries, health care indust

ing methods can produce components with .100 - .125 " wall thicknesses, with a surface

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

finish of 125 rms. They then can be machined to your required dimensions and toleran

.

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

cing.

For more information about aluminum castings, plastic injection molding, forgin

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

Companies that provide selfless information through particip

g technologies, machining and other production methods visit www.manufacturingtips.co

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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