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“Words do not label things already there. Words are like the knife of the carver; they free the idea, the thing from the general formlessness of the outside. As a man speaks, not only is his language in a

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

state of birth, but also the very thing about which he is talking.”

In the top of my coat closet I keep a number of different hats, but when I go for a walk I most frequently put on the black felt one.

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

Examples of combination products may in

In the same way, I recommend that you think of team coaching as just one more hat that you wear at work, a tool that complements the other management styles and approaches you may use.

As a coach, you’ll

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

empower your staff member and help them improve their job performance. And it’s not that hard to get started, even if you’ve never really seen yourself as a coach before. One of the most effective ways t

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

begin the process of creating a climate of coaching is to explain your new goal to your team—you’re a problem solver, a friend, and the owner of the business; essentially, a business coach.

One of the m

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

Combination pro

ost effective ways to begin the process of creating a climate of coaching is to explain your new goal to your team. “At various times I may wear the hat of the business owner, other times as a problem so

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

lver, and at other times, as your friend. Another new hat or relationship I’d like to also introduce is that of being a coach.

You don’t need to claim to be an excellent coach, especially if you’re new.

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

In fact, I’ve found that it’s far better to elicit assistance from your staff, so together you learn how to be both a good coach and coachable players. The key is to communicate, which means everyone take

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

s turns talking and listening.

Introducing the role of a coach to your staff might go like this: “First, I want you to know that it’s my goal and desire to manage this practice as well as I can. I’ve rec

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

ently been introduced to coaching, and feel strongly that developing my abilities as a coach will enhance the quality of our practice and create an environment where we’ll all enjoy working.

“As a coach,

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

my job is to help you be the best you can be at your job. Of course, it’s in my self-interest to have you be great at your job, and I trust it’s also in yours. While I don’t claim to be a masterful coach

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

Following aspects would a

yet, I’m sure together we can learn to create a relationship that helps everyone win.”

Handling personnel issues makes up a good chunk of your job as a coach. And I’m not denying that you’ll continue to

dd to the challenges in developing combination products:

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

face some difficult moments. These strategies from my playbook may help:

Call time out on staff conflicts

While conflicts are a normal part of almost any situation involving human beings, it’s possible

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

to transform a conflict between two staff members into an occasion that will deepen the level of cooperation and collaboration in the future. Conflicts arise when one or more of the people involved become

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

upset. Upsets stem from an undelivered communication (or miscommunication), a thwarted intention or commitment, or an unfulfilled expectation.

Interestingly, these are all internal states. The problem is

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

occurring at an emotional level with the person who’s upset—although most of us think we’re upset about something outside ourselves, that someone else has done something to make us upset. Start by shari

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

Professional from academic institutions, pharmaceutical industries, health care indust

ng this new perspective with your staff members and ask them to work with it for a few weeks. Tell your team that you hope this perspective will help lessen conflicts and encourage cooperation. Then check

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

in periodically to monitor the results. Remember, when introducing a new concept like this, use a coaching approach of “try this on and see how it fits.” Encourage people to keep an open mind, and not le

.

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 their old beliefs get in the way. You can both check in individually, with a “What are you learning about yourself from that coaching conversation we had the other day about upsets,” as well as checking

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

Companies that provide selfless information through particip

in collectively during a staff meeting.

©2005 Brad Swift of Life On Purpose Institute, Inc. This article can be reprinted freely online, as long as the entire article and this resource box are included

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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The only way to develop a sound holistic understanding is to create a framework.

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