Advice You - Business

OK, through your Value Chain analysis you’ve discovered that a key component in your assembly instructions was discontinued. The yellow piece of paper 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

explained Step 13 in tricycle assembly was deleted; the attendant result was a huge up-spike in Helpline calls from frustrated customers asking about Step

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

Examples of combination products may in

13.

Your solution—bring back the yellow. You mention this to management, and it’s approved. It takes a while—after all; you’ve still got the entire curre

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

nt inventory in the stores. But there’s also a quicker way to distribute that flyer. You can email it directly to the customers that call in to the 1-800

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

elpline. Plus, you can post a link to it on your website. Although the frequency of Helpline calls won’t diminish immediately, you can aid in reduc

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

Combination pro

ing the duration of the calls.

At first glance, you might think the above answer to Step 13 illustrates an example of a classic “packaging” solution

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

. Remember, Package is “your face to the customer”. The appropriate package reinforces your Brand in the customer’s mind. But, there is more to it than

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

that.

See you wouldn’t have known the problem existed at all if you hadn’t sought input from Helpline and Shipping staff in your search for a better under

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

tanding of how your company value chain intersects your customer value chain.

In his classic Competitive Advantage Michael Porter ment

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

ions two types of buyer criteria:

use criteria = what your product does for your customer

signaling criteria = how your customer

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

thinks or feels about what the product does for them

Unaided, Step 13 in your assembly process isn’t easy. But, once the customer reads the quick ins

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

Following aspects would a

tructions on the yellow sheet and knows how to properly insert the stove bolt, then it’s a breeze.

Many marketers think of signaling criteria and use crite

dd to the challenges in developing combination products:

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

ia as living in different silos. At least they must, because that’s the way their marketing appears. It’s as if they never talk to their customers about h

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

ow they really use their products.

In reality, signaling criteria can reinforce use criteria and help to position you in an extremely powerful position, es

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

pecially against a competitor that has a superior product.

Imagine that your #1 competitor in the Trike business has no Step 13 in their assembly. They us

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

ed to, but they received so many complaints they engineered it out of the process. To a person not trained in marketing, it might appear that this is an ad

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

Professional from academic institutions, pharmaceutical industries, health care indust

antage the competitor will use to crush you. But you can turn it into a non-event with proper use of the yellow-sheet explanation sheet.

Effectively, you

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

“out-signal” your competitor’s engineering advantage and negate it.

Can you always do this? Of course not. But, inside the mind of the customer, we often

.

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

operate at a closer parity with our competitors than we think.

It’s our job as marketers to make sure we do everything we can to signal to the customer th

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

Companies that provide selfless information through particip

at our product is, in fact, performing for them up to their expectations, not ours.

And a Value Chain analysis is a great tool to insure that happen

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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