Write You - Business

The business world sometimes appears to be a war zone. Customers and clients feel that businesses don’t respect them. Workers mutter about the treatment from customers or clients, co-

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

workers, supervisors, or employers. Employers complain about employees and customers or clients. Everyone seems to be angry about someone else. Let’s choose one battleground and exami

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

Examples of combination products may in

e it: the relationship between business’ representatives and customers (which includes clients). The old adage still exists somewhere that the customer is always right.

Mrs. Smith fum

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 as she left the store. If the door weren’t automatic, she would have slammed it behind her. “Fifteen minutes I stood there while those clerks visited. Don’t they know without custome

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

s, they wouldn’t have jobs?” she complained to her friend. That business probably lost a customer.

In another business, the receptionist tried to keep a smile on her face as a client

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

Combination pro

berated her because the person he wanted to see wasn’t available. “I’m sorry, sir. Mr. Moore had a meeting across town and hasn’t returned. I’ll gladly take a message.” She smiled broa

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

dly. “I’m sure he will contact you as soon as possible.” She shrugged. “I really don’t know what else I can do unless you’d like to talk to someone else.”

The angry man paused and sta

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

ed at the young woman. “I’m sorry. There’s nothing you could do. I’m sorry I took my frustration out on you.” He gave a half-smile. “Is there someone else who might help me?” That busi

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

ess probably kept a client.

At an ice cream shop that made their own ice cream sandwiches, a woman ordered one of the sandwiches. The clerk informed her that the ice cream hadn’t had

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

ime to solidify yet, but if she would wait about ten minutes the sandwiches would be ready. The woman glared before stating, “I want one now. I don’t want to wait ten minutes.”

“If I

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

give one now, ma’am, the ice cream would drip everywhere. I don’t think you’d be satisfied.”

“I don’t believe you. Now are you going to give me an ice cream sandwich or not?”

The cle

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

Following aspects would a

rk looked toward her supervisor who gave a brief nod. The young clerk went to the freezer and removed a paper wrapped sandwich. She took the woman’s money and gave her the sandwich. Th

dd to the challenges in developing combination products:

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

woman walked out of the shop and returned moments later, ice cream dripping down her blouse. “Look at the mess. I want my money back,” she yelled.

The clerk hesitated, not sure what

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

he should do.

“I said I want my money back, and now,” the woman insisted.

As the clerk opened the money drawer, her supervisor joined her. He patted her shoulder. “Give her the money

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

” He then turned to the woman on the other side of the counter. “You owe this young lady an apology. She told you, and very nicely, that the sandwiches weren’t ready, but you insisted

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

he sell you one. You do not have the right to speak to her as you have.” He took a deep breath and continued calmly. “Please take your business elsewhere if you can’t or won’t treat my

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

Professional from academic institutions, pharmaceutical industries, health care indust

employees better than you did Marsha.”

That business may have lost a customer, but the supervisor was correct to support his employee since in that case the customer was not right.

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

s the customer always right? No, but many times she or he is. People relying on customers or clients in order to have a business need to treat the customers with respect. If employees

.

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

re being mistreated by a customer, a supervisor should step in and protect the employee. Personal conversations and personal business should wait until the customer’s needs have been m

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

Companies that provide selfless information through particip

t. Many times a smile and respectful speech can change the attitude of an unhappy customer. Most of the time the customer has to be happy in order for an employee to have a job to keep

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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