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Recently while waiting for our lunch to be served in a nearby restaurant, my husband Michael and I were discussing our son’s upcoming science fair project. Michael was describing the steps that my son should follow to complete the assignme

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

nt. While Michael was going through this elaborate process, I diligently tried to follow what he was saying, but I sat there completely clueless. As I struggled to gain a better understanding of what he was talking about, my normally affa

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

Examples of combination products may in

ble husband started to show distinct sings of irritation. His unspoken message was ‘what’s wrong with you, why don’t you understand me?” He then proceeded to draw his plan on a napkin in an effort to get his brilliant idea into my dense h

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

ad. It worked. When Michael started to show me what he was describing, I was able to easily understand his ideas.

People often have problems when they communicate with each other. The communication process is very complex and there are

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

many opportunities for breakdowns to occur. As a result, people can become frustrated, instructions are not carried out correctly, people get offended, and conflict can occur. You can minimize these problems and increase the odds that oth

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

Combination pro

rs will understand you by following these simple steps:

Take responsibility for the communication – When we communicate with others it is very tempting to blame them for not understanding us. Surely we with our outstanding orato

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

ry skills cannot possible be at fault. The problem with this attitude is that it does not achieve our outcome of getting the other person to comprehend what we are trying to say. When we take responsibility for getting a message across to

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

others it frees us to do whatever it takes to achieve that result.

Check non-verbal feedback – When you speak to someone don’t assume that you are making yourself clear to the other person. Check for non-verbal feedback. People give

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

us many clues as to whether or not they understand us. Do they look confused? Are they unusually quiet? When asked if they have any questions, do they answer with a hesitant no? These are all subtle signs that the individual is not sure

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

of what you just said. Continue communicating until you see signs that your message has gotten through.

Be flexible – When communicating with others, he/she who has the most flexibility wins. If you speak to someone and you can tell

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

by the non-verbal cues that he has no idea what you are talking about, change the way you are communicating. That is what my husband did. When he realized I did not understand his words, he began drawing pictures. Keep changing your comm

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

Following aspects would a

unication style until you find the one that works with that particular individual.

Recognize that people understand information in different ways – People do not understand things in the same way. Some people understand things better

dd to the challenges in developing combination products:

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

when they see them, others when they hear them and others when they do or get a feeling about them. Several years ago, a life insurance salesman came in to meet with Tammi, one of my employees, to discuss insurance needs. He started to de

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

cribe different insurance options and as he was doing so, Tammi’s eyes started to glaze over. I could tell that she had no clue what the salesman was saying. (He obviously wasn’t very good with non-verbal cues.) I told him that Tammi und

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

erstands things better when they are written down. He replied that he would write things down later on in his presentation. (I guess flexibility wasn’t his strong point either.)

When he finally began to write things down, it was as if a

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

ight bulb had gone off in Tammi’s brain. Her eyes cleared up, she shook her head up and down at key point and it was obvious by her non-verbal feedback that she was beginning to understand the salesman’s presentation. Use non-verbal cues

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

Professional from academic institutions, pharmaceutical industries, health care indust

to determine if the person understands you. If not, try showing her what you mean or getting her emotionally involved in what you are saying.

Don’t Make People Wrong – When we communicate with others the chances are very good that we

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

will have to change strategies along the way. Don’t make people wrong because their communication style is different from yours (no what’s wrong with you attitude.) If you do, you will not only have to deal with communication problems but

.

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

also conflict and negative feelings. Instead recognize that each person’s uniqueness adds color to the mosaic of life and do whatever you need to do to get your message across correctly.

While it isn’t possible to completely elimin

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

Companies that provide selfless information through particip

ate communication problems, by following these steps you can minimize misunderstandings, reduce frustrations, and achieve better outcomes. As for Michael, he’s learned to draw pictures for me when we talk and now I understand him just fine

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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