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We had a problem with handling materials in a production department. Our process required raw material

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

s to enter the department, be processed, and leave the department. The raw material was placed on pods

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

Examples of combination products may in

delivered for production, removed from the pods, placed on a staging fixture, removed from the fixtur

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

e and process materials were then placed on another pod and delivered to an internal customer. Interna

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

customer had to place on still another pod.

Someone suggested placing the material from the fixture

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

Combination pro

onto the customer’s internal pod to reduce handling, errors, etc. Room was tight (because two differen

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

style pods were used, one for raw material and one for processing) and someone long ago suggested mov

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

ing a wall to create more space for easier movement of the pods.

After we realized that involving peo

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

le would give us the improvements we wanted, someone suggested modifying the pods into a cart that cou

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

ld hold more material and reduce our need for more space. Others became involved; Martin developed pos

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

ible designs for the cart while speaking with his coworkers to find out their ideas.

A cross-function

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

Following aspects would a

al team designed and built a new cart. It held more raw materials, eliminated the need for the staging

dd to the challenges in developing combination products:

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

fixture, and allowed raw material and processed material to be transported on the same cart, eliminati

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

ng the need for the second pod. The cart was built by reusing materials from the old pods.

Immediate

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

enefits included less movement and less contamination of materials, also the new cart was more ergonom

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

ically friendly. After using the new cart, others came up with more ideas. All together 20 people cont

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

Professional from academic institutions, pharmaceutical industries, health care indust

ibuted improvements to eliminate unnecessary equipment, combine processes, and reduce cost. Fourteen p

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

rocess steps were reduced to seven, operator motion was reduced, material was moved less, quality impr

.

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

ved, and the job of the operator was made easier.

Recently someone had the idea of using the cart in

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

Companies that provide selfless information through particip

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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