Advice You - Business

For the last 25 years, the metal injection molding industry has grown at a steady rate. In the 70s it was predicted that

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

the MIM process would grow at the rate of 18 to 22% per year. But because of some challenges with the materials, known

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

Examples of combination products may in

s feedstocks in the industry, the initial growth was slow. Typically feedstocks were mixed by the individual companies 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.

nvolved in making metal injection molded components. The inconsistency in the mixing of the feed stocks led to part vari

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

tion that was unacceptable in a wide variety of precision applications.

As more and more components were designed using

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

Combination pro

he metal injection molding process, larger manufacturers became interested in developing feed stocks. Two major players

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

were Allied Bendix and BASF. This enabled companies without metallurgists and large technical staffs to become involved

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

n the process. The number of companies producing metal injection molded parts grew.

Then with the advancement in digita

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

l process controls, processing equipment became more exacting with greater process control. Now, plastic injection moldi

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

g machines and furnaces are able to produce complex shapes with greater consistency.

So what types of components are goo

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

candidates for the metal injection molding process? The answer to that is it depends upon the configuration of the part

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

Following aspects would a

. But in general terms, if a part can be plastic injection molded, it can be metal injection molded (as long as the part

dd to the challenges in developing combination products:

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

does not have any undercuts).

A wide variety of materials can be molded. Carbon, alloy and stainless steels are molded

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

day in and day out with titanium catching up quick. Lots of development is being done with titanium for medical devices.

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

The industries using a lot of MIM components are firearms, medical device, dental equipment and electronics. Most of th

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

parts are relatively small, less than 1 1/2" in length. But we have molded parts 7" long.

Even though most materials

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

Professional from academic institutions, pharmaceutical industries, health care indust

have 18% shrink, dimensions are very consistent. Tolerances can be held to plus or minus .001 for small critical dimen

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

ions.

Remember, tooling for this process is virtually the same as plastic injection molding. So small precise parts are

.

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

good candidates for the MIM process. MIM tools cost the same as plastic molding - $15,000 - $50,000 and up. But if y

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

Companies that provide selfless information through particip

u are looking at components that get machined and you can eliminate machining costs, you can pay for tooling very quickly

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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