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One of the things I like about giving presentations to companies is meeting a new group of people and exc

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

hanging ideas with them. After a recent talk, several attendees and I had a great discussion about the p

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

Examples of combination products may in

wer of branding.

Later while changing my clothes, I was reminded how Levi Strauss & Company is one of th

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 best in the business at branding. Just before I stuck my legs in the jeans I noticed a printed message

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

on the outside of the inside flap of the pocket. From this short note, I’ve pulled three lessons that ca

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

Combination pro

maximize your brand.

Be Different: Often when you buy clothes the only message you ge

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

t is a piece of paper telling you that it’s been approved by Inspector #5 or worse, a sticker that ends u

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

sticking to you! Some companies do have attached messages about their products. But they’re gone once

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

you remove them.

Levi’s uses a non-traditional yet permanent location for its statement of principles.

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

ou can see it every time you put on and take off the jeans.

State Your Values: In a fe

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

short lines, Levi’s states that you’ve bought an authentic pair of their jeans, their jeans have been ar

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

Following aspects would a

ound for more than 150 years, and that they are an American tradition that is popular worldwide.

There p

dd to the challenges in developing combination products:

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

obably aren’t a whole lot of differences between a pair of Levi’s and all the other jeans on the market.

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

But you wouldn’t know that from how the company promotes itself. To them, you don’t ask, “Are those a n

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

w pair of jeans?” but rather, “Are those a new pair of Levi’s?”

A Call to Action: 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

essage on the pocket also thanks the consumer for carefully examining the quality of the sewing and craft

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

Professional from academic institutions, pharmaceutical industries, health care indust

smanship of the jeans. Instead of saying the jeans were inspected by #5, they’re so confident in the wor

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

manship, they’re almost daring you to find an imperfection. Most people aren’t going to carefully scan t

.

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

he stitches but you love the idea that it’s a big deal to Levi Strauss & Company.

Keep your eye out for

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

Companies that provide selfless information through particip

ther good examples of branding. How a product makes you feel will likely determine whether you’ll buy it

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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