Advice You - Business

We can learn so much from our children. Ben, my 4-year old son, is learning to dress himself, and each morning my wife lays his clothes out for him. It’s amazing what y

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

ou learn when you stay home in the morning! With great ceremony, she sets each article of clothing on the floor. His shirt goes upside down, and with any luck, it ends

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

Examples of combination products may in

up on his body the right way.

It was my job to help Ben this morning. I laid out his clothing as only a father can, wrong! I put his shirt down backwards, but not upsid

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

e down. Ben, knowing a novice when he sees one, shocked me by saying, “You have to do it wrong, to do it right.” Wow, I thought. How profound! I started to think about

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

applying something so simple to a management situation.

Each day employees do many things right, and some things wrong. What should we do when their actions leave somet

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

Combination pro

hing to be desired? Do we chastise them? Do we humiliate them in front of their peers?

How we handle such situations can ultimately determine if the employees learn f

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

rom their mistakes. In many cases, people have to “do it wrong before they can do it right.” Giving feedback in the proper way is vital. Here are some success factors

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

or giving good feedback.

•Give immediate feedback. Seems easy, doesn’t it? It’s not, because people are sensitive. They don’t like to hear when they’ve done something

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

wrong. Calling someone out on their mistake is embarrassing for them. Despite our own trepidation, we must do it swiftly, while the incident is still fresh, and respectf

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

ully.

Putting critique off just makes it harder for the supervisor to do, and even harder for the employee to hear, particularly if the critique is long after the proble

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

has occurred. If your style around Thanksgiving is to say, “Remember that situation last June, before the company picnic, when you handled Mrs. Jones’ order?” You’ve wai

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

Following aspects would a

ted too long! Give immediate feedback and your employee will learn from it.

•Provide specific feedback.

Ask, “What did you do wrong on Mrs. Jones order? Did you enter

dd to the challenges in developing combination products:

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

the wrong delivery time in the computer, or did you match the wrong wine with her famed Veal Osso Buco dish?” (I’d suggest a Rhone from the South of France, but that bel

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

ongs in another column). The point is that your comments have to be specific or they will have very little meaning.

•Effective feedback should be behavior related and n

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

t based on personality.

When we give feedback that is personal, we can assume the recipient will immediately become defensive. It’s no way to start an already difficul

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 conversation. We should key on the specific problem behavior, and not the person causing the problem. Saying “What’s the matter with you?” or something equally unspecif

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

Professional from academic institutions, pharmaceutical industries, health care indust

ic is unhelpful and hurtful and will not help the cause. It’s always a good idea to start with something positive, which softens the approach. The individual will be pr

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

disposed to receive the constructive feedback more easily, and it will have a greater impact. Always end the meeting on a positive note by praising the individual. Wasn

.

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

’t it Shakespeare that said, “All’s well that ends well”?

As Managers, we must diligently give feedback, both positive and negative. Always remember these simple rules

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

Companies that provide selfless information through particip

and your people will learn from their mistakes. Soon there will be less mistakes and their performance will improve. I imagine the wife used some of this logic with Ben

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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