Main Subject - Business

In my book Talking Points: 25 Tips for Clear, Credible Communication, Tip #17 states: “Managers and professionals in positions of responsibility got there by finding solutions to problems. They didn’t rely on someone else to come

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

up with the remedy. They worked to find solutions proactively.” Those of us in positions of responsibility can demonstrate our management fitness by looking for and adding a proactive step whenever we encounter potential problem

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

Examples of combination products may in

. Adding that proactive step demonstrates our ability to take responsibility for the outcome of situations. Nothing speaks “management” more than this.

Finding creative solutions to unusual and routine situations helps develop

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

your management skills.

In addition to taking that proactive step ourselves, part of our responsibility as managers is teaching our staff how to do this for themselves. Most of us in our careers have worked for a manager who ten

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

ed to monitor every detail of our work. The result is we felt no empowerment to seek solutions on our own and to find methods of handling problems without that person’s involvement. The problem this sort of micro-monitoring cause

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

Combination pro

is lack of motivation on the part of the employee to seek out alternative, workable solutions.

Usually a micro-monitoring manager has an idea in mind about the best process or best solution when dealing with a problem. This “be

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

t process” generally comes from that manager’s experience of having had that particular solution work the last time on a similar problem; hence, the attitude is born that this one solution will work on every similar problem. This

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 where the rut begins. When managers rely on solutions that worked in the past for current situations, they are no longer open to new ideas. As a result, they tend to direct their staff to use those same solutions on every pro

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

lem in the future. The staff, then, begins to lose creativity when they encounter problems.

This method of management causes problems. It doesn’t encourage creative problem solving among employees, nor does it encourage employee

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

to try new ways of doing things. Instead, employees who have worked under this sort of manager previously will look to their next manager to “solve” their problems for them. And if these employees aspire to positions in manageme

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

t while relying on their managers to solve their problems, they will find their aspirations thwarted.

The staff members who are promoted above their peers to positions in management get there because they demonstrate their manag

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

Following aspects would a

ment fitness in finding solutions to problems and finding creative solutions to unusual and routine situations. When in management, these new managers run the risk of solving their staff’s problems because they enjoy problem-solv

dd to the challenges in developing combination products:

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

ng so much. But these managers are going to have to remember how they got there and encourage their own team members to be creative in finding solutions to their own problems and not solve them for their team.

One of the best wa

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

s to encourage staff members to find their own proactive solutions is to use a series of questions to help them realize you are empowering them to seek solutions. For instance, let’s say that your employee, Sam, comes to you with

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

a situation—perhaps a failure in a process. Sam presents the situation to you by saying the process failed and then he asks what you’d like him to do about it. Instead of telling Sam what to do, ask Sam what he thinks should be

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

one. Sam may at first be hesitant to give you any ideas because he may be gun-shy from previous micro-monitoring managers. Be patient with Sam; build trust with him so he knows you are truly interested in his ideas and that you t

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

Professional from academic institutions, pharmaceutical industries, health care indust

ust his ability to work things out.

You might try a process I call the “blue sky” thinking process. Consider posing a question to Sam this way: “If money and time were not an issue, what would you do to solve this dilemma?” In e

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

ery wacky idea, a good idea is waiting to be developed. Through a series of questions and answers with Sam, you’ll discover that a good idea is just waiting to come out. And Sam’s confidence and creativity will be awakened. He’ll

.

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

learn through this repeated process to start coming up with his own solutions. As his manager, you’ll set the appropriate accountability with him on implementing his solutions so that Sam doesn’t act without the proper authority

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

Companies that provide selfless information through particip

o do so.

Following this process will not only increase Sam’s management fitness by learning to find proactive solutions, it will further demonstrate your own management fitness by growing your staff into creative problem solvers

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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