Main Subject - Business

Mistakes happen and they often occur when you can not afford them. I remember one painful mistake many years ago. I was managing a print shop and an important customer came

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

in for their business card order. The business cards were printed, but needed to be cut down to size. I went to the drying rack and took them to the paper cutter. I placed

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

Examples of combination products may in

the cards in the cutter for the first cut, pushed the button and *$%&. I watched the powerful cutting blade slice through the logo of the cards. I wanted to run out the doo

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

and hide. Apparently, someone had placed the top card upside down and I didn't check the stack of cards for position. It was clearly my mistake and the customer would not

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

e leaving with their finished business cards.

I took the cards to the front counter and showed my mistake to the customer and admitted that it was my error. The customer w

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

Combination pro

s upset, but understanding. In this situation the only solution was to ask the customer what they wanted us to do. I remember vividly how the customer handled the situation

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

He stood there for a minute and I waited for him to tell me to quit my job and drive off a cliff. He was very understanding and asked if we would deliver the order when it

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

was finished. I was both shocked and pleased the customer took it easy on me.

The Customer is Always Right and Often Forgiving

In my story, we admitted

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

ur mistake and were able to show the results of my error. We reprinted the cards and delivered them to the customer to their satisfaction. We didn't discount the business c

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

rds because the customer didn't ask us to. The customer didn't ask for anything special. They just asked us to deliver their business cards as soon as we could. Well, we re

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

rinted the business cards and I personally delivered them. The customer will always be gracious when they understand a situation and will help you through a challenge when

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

Following aspects would a

you are up front with them.

We simply performed what we needed to do to resolve the situation. I remember willing to do just about anything we could if the customer would

dd to the challenges in developing combination products:

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

ave asked. The customer didn't ask and remained a key customer for years because we were human and continued to perform for them.

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

Production mistakes happen when you are rushed and pushed to perform. Every manufacturing business should have a production schedule. The business will run smoothly wh
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
n this production schedule is maintained. Not every job requires rush service and production performs better when it follows a regular schedule.

Never ask the cust
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
mer when they need their order. They will always want it sooner than they need it. Instead, tell them when it will be ready. If they need it sooner than your schedule allow
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
, they will tell you. If they need a job sooner, move up the job to match their schedule. When you deliver their job sooner than expected, the customer will appreciate it m
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
re.

Check and double check some areas of production. In the cutting area, I recommend the old adage of "measure twice, cut once". Develop a culture of do
.

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
ble checks to eliminate errors.

Automate your business with technology to eliminate mistakes. At Selling Magic we automate the selling process so you can
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
do more in less time. Think of our system as you would a robot that does not make mistakes. Automation in production and selling will deliver a business advantage.

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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Main Subject - When Mistakes Happen - Do What You Are Trained To Do

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