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When you’re ready to invest your time in developing a solid Value Chain analysis, you want to leverage that time in the most efficient and effective manner. That means looking in the mo

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

st high-value places in both your company and in your customer’s interaction with your product (service).

A good place to start is by discovering complaints from your customer service d

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

Examples of combination products may in

ept.

Imagine you are in the tricycle building business. You sell your trikes partially assembled to retailers who sell them to end users. You pack assembly instructions in the carton

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

that the trike comes in. Plus, you supply a 1-800 customer Helpline staffed during daylight ours.

OK, as a smart marketer you decide that the Helpline folks who handle those1-800 assem

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

ly questions are a great place to start in your Value Chain analysis. You discover that 40% of the customer calls relate to an assembly question for a one inch stove bolt that is part

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

Combination pro

of the rear axle assembly. Customers invariably can’t figure out how to properly tighten this bolt.

It’s Step 13 in the assembly process

So, you dig a bit. You ask the requisite who

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

/what/when questions concerning the product, model changes, has this particular question been asked in the past, was there a change in supplier, just when did this question became the

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

dominant Helpline question, etc.

After you’ve pulled more than a few hairs out, you realize that the Helpline staff has discussed this problem with the folks in product development

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

Creating an engineering solution would involve an expensive retooling and it just isn’t worth it. But, it isn’t like the Helpline staff never tried to solve the problem. That’s a rel

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

ief. So you thank your lucky stars your staff wants to make it easier for the customer—it’s not an adversarial relationship.

But, you find out that Helpline staff never discusse

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

d the stove bolt problem with Shipping, and never spoke of it with Marketing. You speak with both, and uncover a key fact: In a previous model, there was actually an additional, separat

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

Following aspects would a

e flyer on brightly-colored yellow paper that was a supplement to the assembly brochure. This yellow flyer instructed the customer exactly how to tighten the bolt. The bright yellow pa

dd to the challenges in developing combination products:

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

er really leapt out when the customer opened the tricycle’s packing carton. There was no way to miss it.

But the separate flyer cost a bit more money, and it was one extra piece to ins

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

ert into the package, and sometimes they’d get left laying about on the floor and get swept up and trashed; so in a round of cost-cutting Marketing was ordered that the yellow flyer be i

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

ncorporated into the body of the assembly instructions.

There wasn’t any battle. There wasn’t any consulting of the 1-800 Helpline staff, there was just acquiescence on Marketing’s par

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

t—they had to write a new ad campaign anyway and fighting for some assembly copy’s right to stand alone on its own flyer just wasn’t worth it. Truthfully, nobody in Marketing thought mu

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

Professional from academic institutions, pharmaceutical industries, health care indust

h about it. So they just pulled out their old copy of the Assembly instructions, and underneath the stove bolt step, where it used to say: “See attached flyer” they simply double-checke

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

d to see that they had the right copy in place, determined there wasn’t enough room for the illustration of the stove bolt that was on the current flyer without over-sizing the assembly

.

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

instructions, and so they dropped the illustration and just left the copy.

That’s how Step 13 in the assembly of the trike became notorious among the Helpline staff.

Of course, you’ll

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

Companies that provide selfless information through particip

come up with a solution. And that solution will look like a Package solution—which it is—but it’s a solution as a result of a Value Chain analysis.

We’ll review your solution next time

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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