Advice You - Business

A few weeks ago, some friends and I were on our yearly trip to Nantucket. According to ritual we stopped by our favorite ice cream shop as soon as we got of

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

f the boat. My friend asked for whipped cream on his small cup of chocolate ice cream. The clerk proceeded to tell him that “whipped cream only comes with s

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

Examples of combination products may in

undaes.” Thinking it was a cost issue, he offered to pay the extra twenty-five cents that they charge to put candy on a cup of ice cream, which he felt woul

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

d surely cover the cost of a squirt of whipped cream. The clerk refused the offer saying that was the “candy charge” and there is “no way” to charge him for

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

just whipped cream. She went on to say that “the shop policy is that whipped cream can only be put on sundaes.” So in order to get whipped cream. he would

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

Combination pro

have to order a sundae with no hot fudge, no nuts and no cherry.

He settled for his chocolate ice cream without the added calories, but for the rest of the

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

weekend we all had to listen as he told the entire island (or at least the half that would listen) how ridiculous this policy was. Needless to say, we did

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

ot pay a visit to that shop on our way back to the boat and it probably won’t be our first stop on the island next year.

Small things can turn a basic inte

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

raction into an extraordinary customer experience or a massive disappointment. This story illustrates how a too restrictive policy hurt the clerk’s chance t

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

o be extraordinary and ruined any chance of maintaining my friend as an advocate. All too often companies that claim to be creating better and more standard

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

ized customer experiences end up micromanaging their way out of customer loyalty by creating inflexible rules and policies.

Honestly, I don’t know why the

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

Following aspects would a

“no whipped cream” policy was in effect. Maybe it had something to do with inventory control, maybe the clerk didn’t know how to ring it up because it was n

dd to the challenges in developing combination products:

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

ot a standard sale, or maybe the manager emphasized during training to only put whipped cream on sundaes. Whatever the reason, the clerk didn’t feel empower

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

ed to solve the problem and create an extraordinary customer experience and therefore the policy hurt long-term customer loyalty.

Instead of trying to crea

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

e specific rules which dictate how employees should act in all situations, companies must instead examine all aspects of their business and define broader g

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

oals and values which guide the organization. The company can then put employees in control of living up to these broader guidelines and encourage their sta

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

Professional from academic institutions, pharmaceutical industries, health care indust

ff to be responsible for determining what is adding to or subtracting from the customer experience and act accordingly.

The customer is NOT always right, b

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

ut if you want to retain a loyal patron you need to do everything you can to ensure that they have an extraordinary experience each and every time they 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

with you. By outlining the broader goals and values for the organization to follow, the employees are able to interact with the customer in a way which seem

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

Companies that provide selfless information through particip

s right for the situation, instead of going through a predefined set of motions which does not fit the situation and will never result in a positive outcome

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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