Main Subject - Business

Trust is the fundamental currency of business. Without trust our economies cannot function. And yet many organisations, teams and individuals struggle with trust. They struggle to

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

gain their customers trust; they fail to develop their employees trust. Without trust stakeholders become cynical, disillusioned and de-motivated. Where they can, they move on. Hop

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

Examples of combination products may in

fully to work with others (suppliers and employers) in whom they can trust.

How about your organisation? What level of trust do you think you deserve?

Here is a short test.

Consid

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

er how many of the following undermining behaviours are to be found in your organisation;

Saying one thing and doing another
Not following through on commitments

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

li>

Taking credit for another’s work

Not sharing information in a timely manner or at all

Shooting the messenger

Listening with the intent to repl

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

Combination pro

rather than understand

Not delegating the best assignments to help develop others

Revealing confidences and confidential information about others

Sho

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

wing superficial concern about others

Acting like you know something you don’t

Being defensive about feedback

If you see any of these behaviours regul

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

rly demonstrated by your employees then you probably have a problem. One that without action on your part could lead to the destruction of any trust that still exists. Ultimately l

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

w or no trust organisations become dysfunctional and fail to achieve results. The end result is going to be failure.

What can be done?

Firstly, own up to the problem. Recognise an

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

d accept that it is a real problem; one that needs to be given priority. Also appreciate that it starts at the top. Building trust cannot be achieved if the prevailing attitude is –

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

Do what we say, not what we do.

One of the most effective ways to build trust is to work with the 3 C’s (as used by Novations Consulting Partners).

Consideration – conveying a genui

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

Following aspects would a

e interest in the well being of others. People are more likely to trust you if they believe you share their concerns about the success of the organisation, if they believe you care a

dd to the challenges in developing combination products:

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

bout their needs and if they believe you will go out of your way to help them when they need it.

Credibility – conveying evidence that you are trustworthy and have relevant knowledge

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

skills and influence. People need to have confidence that you have the required knowledge and ability to do your job and that you can successfully exert your influence to be effecti

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

e in the role. Most importantly people must believe that you are ethical and honest.

Consistency – providing steady, reliable guidance, support and follow-through to accomplish the

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

work. Consistency is based on reliability and dependability. It means making sure your actions match your words. It means following through on the commitments you make. It means s

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

Professional from academic institutions, pharmaceutical industries, health care indust

tting clear standards and expectations and then providing the support necessary to attain the goal.

Creating a climate of trust taps into people’s desire to contribute and feel value

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

. People who trust and are trusted are more productive and loyal. They communicate openly and directly. They are willing to share ideas and take appropriate risks. They show creat

.

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

ivity and initiative. In other words – organisations based on trust work better.

Wouldn’t you want to work in one yourself?

Trust – takes a lifetime to build and just a moment to l

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

Companies that provide selfless information through particip

se. You might think about including a session on trust on the agenda of your next board meeting or team session.

And contact me on +44 (0)1252 727980 for more information and advice

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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