Advice You - Business

The v-process casting method was first developed in Japan as an innovative method for manufacturing precision automotive componen

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

ts. The process is not widely known by engineers in the United States because it is not highly publicized and there are very few

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

Examples of combination products may in

roducers in North America.

But the process is really terrific for a number of reasons:

1) the tooling costs are relatively inexp

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

nsive.

2) tooling changes can be made easily and cost effectively.

3) precision castings are made with a smooth surface finish.

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

4) process can be utilized for prototyping as well as supporting production quantities.

5) piece price is competitive with die c

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

Combination pro

sting through 15,000 pieces.

Let's take a look at each one of the five reasons listed above. First, tooling is precision machined

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

out of a polymer that is tough and durable. And very easy to machine. Solid models are downloaded to CNC software which creates

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

he tool paths of machine the patterns. Cutting time is fast and tools can be made over a couple of days.

The tools are a replic

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

of the part(model) to be cast. A cope and drag(top and bottom) is made. The tools are then mounted can then be mounted into th

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

V-Process machine. Tooling price ranges from $5,000 to $25,000 (even for the largest parts).

Second, tooling revisions. Minor t

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

oling revisions can be made in less than an hour. Major revisions will take longer but still very quickly. If material needs to

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

Following aspects would a

e added to a certain section of the tool, blocks can be inserted and cnc machined.

Third, smooth precision castings. Because the

dd to the challenges in developing combination products:

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

old is made up of fine sand held together by vacum and a thin(.005 thick) surlyn sheet, the castings have a surface finish 125 rms

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

r better. The castings are produced with a minimum wall thicknes of .125.

Fourth, casting setup takes minimal time. Tools can be

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

huttled in and out of the equipment in about ten minutes. Down time is minimal. Plus the tool can be cycled over and over to produ

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

e the required number of parts. Normal production quantities are 500-2000 pieces at a time.

Fifth, the process is competitive wi

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

Professional from academic institutions, pharmaceutical industries, health care indust

h die casting. Now with large automated turnstyle type equipment, cycle times for this process are faster than ever. Large compo

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

ents (24" x 18") can be cast just as fast as smaller components. So if you take into consideration tooling costs for large die cas

.

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

components ( $ 150,000 and up), you can produce a lot of castings in the V-Process and be competitive with die casting.

If you wo

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

Companies that provide selfless information through particip

ld like more information about v-process casting, subscribe to www.manufacturingtips.com and request information on aluminum castin

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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