Advice You - Business

Phrases like “walk the talk” and “lead by example” are commonplace management and leadership language. These phrases provide frameworks for discussion on effective leadership. I’ve even used them in past ar

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

ticles. That said, I want to make the case today that it is not enough in today’s marketplace to simply “walk the talk” or “lead by example”. Both of these phrases lack the intent to change and improve. Ch

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

Examples of combination products may in

nge is always happening and continuous improvement is vital to our businesses today. Consider this alternative phrase instead: “Improve to Lead.”

When have you ever heard the phrase, “improve to lead”? I c

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

n’t imagine you, or too many others, are nodding your heads right now and thinking, “sure, I hear it all the time.” A short analysis of the business books lining the shelves of the national bookstores and th

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

public library in my area show that the focus on improvement is regarding processes, not people, not managing, and not leading. There is sure to be a counter-point to this debate that says “improvement is i

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

Combination pro

plied in our common leadership phrases”, like those mentioned earlier. I submit to you that improvement is not implied. Without a conscious reminder that improvement must be a regular part of doing business

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

it is too easy for people to become comfortable and even complacent in their jobs. Improvement implies change and people inherently do not like to change. This may be why the phrase “we’ve always done it t

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

is way” is also commonplace in business.

The “we’ve always done it this way” phrase, or some form of it, can become common rhetoric when people are not encouraged or empowered to seek continuous improvement.

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

Always doing things the way they have always been done gives the mind permission to shut off. Mistakes can be made when people don’t understand the “how” and the “why” behind a process they execute. An und

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

rlying assumption in this article is that mediocrity and complacency are bad for business. So, as a leader, how do you combat these business busters?

Successful leaders today realize that they must continua

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

ly improve themselves and be change agents for improving the business. This is not advocating change for change’s sake, but rather improving or changing when it can positively impact you or the organization.

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

Following aspects would a

Lead by fostering continuous improvement. In other words, improve in order to lead.

Start with yourself. Improve yourself and become a stronger leader than you are already. Establish a plan for your own

dd to the challenges in developing combination products:

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

improvement and make it known to those around you. Identify ways you can do your job better and then look around to see if others might benefit from your discovery.

So how do you do this? How do you have a

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

continuous improvement attitude all the time? To start, you can simply ask the following questions:

*

Have I thought through all the options?

*

Am I allowing different points of view to surface?

*

Is t

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

ere a better way to do this?

*

Is there a more efficient way to do this?

*

Is this approach a band-aid or does it really fix the problem?

*

Do those around me understand that they can make suggestions 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

d offer up improvements?

Continue into your department. Improve the ability of the department and create a great team. Encourage team members to find ways to improve themselves. Empower your team to chall

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

Professional from academic institutions, pharmaceutical industries, health care indust

nge the “we’ve always done it this way” parts of their jobs. Give people permission to explore new and better ways of doing things. Identify ways people can develop themselves.

Expand into the whole compan

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

. Improve processes that are cross-departmental and improve the whole company. Work with your peers to establish task forces or teams to focus on workplace improvements. Share the improvement plans you hav

.

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

and your team have created as a best practice for the organization. Evangelize continuous improvement and you will be improving to lead!

"Improve to lead" is an on-going effort that can be embraced by anyo

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

Companies that provide selfless information through particip

e at any level. As a manager and leader in an organization, take the lead on the effort. The more people see your willingness to look at new ways of doing things, the more they will embrace the idea as well

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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