Advice You - Business

Delivering the greatest return on investment is clearly what every business leader wants. Experienced leaders may indeed be better qualified to undertake specific tasks than most of the people on the team. Leaders presumably attained their positions in part by their outstanding perf

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

ormance and experience in similar roles. However, does that really make them the best person to do the job?

“If you want it done right, do it yourself!” Does that sound familiar? Heard it at work lately? Said it yourself perhaps? Did you feel motivated hearing your boss say that

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

Examples of combination products may in

? Did it build any trust between the team and the boss? Does it show confidence on the boss’s part? Does the team feel confident? Do they feel empowered? Will they really go all out and do their best? What’s likely to happen the first time they make even a small mistake?

Balanc

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

ing the desire to control the process and the outcome against the need to empower the organization to perform at its peak can indeed be a challenge. To be successful, a leader must learn to use their experience and expertise to direct, to guide, to advise, to motivate, and to nudge 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

he organization toward expected objectives. In sports, a good coach functions in the same way with the players on the team. Playing the game is still the job of the team, not the coach.

A good coach learns to identify and exploit the unique talents and skills of each individual pla

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

Combination pro

er. Then with the expertise and guidance of the experienced coach, the team is molded and shaped into a high performing and unique engine. Team members performing at heir full potential, each knowing what is required of them and how to work with the others, and all united to a commo

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

n purpose will be empowered to make the best decisions and create optimal solutions to move forward. This powerful engine will drive the company toward its goals with seemingly unstoppable momentum.

Maintaining absolute control over every action and dictating how each process and mi

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

lestone is to be achieved will not achieve this kind of empowerment. Leaders must learn to trust the team. They must accept that the team will often choose different approaches to solving problems or managing projects. They might even feel uncomfortable with the approach chosen as

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

they could have done it better. This is where the leader needs to step back and look at the bigger picture. That is, how can they motivate and empower the entire organization to believe in and accomplish the goals and mission of the company?

Brushing team members aside and rushing

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

in with both feet to personally tackle the task directly will most likely demoralize the entire team. They will not feel respected for their abilities nor appreciated for anything they accomplish. The signal is that they are not good enough. They will similarly not be highly motiv

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

ted to put forward creative ideas to solve problems and move the business ahead faster. Most likely, they will crawl into their defensive shells and avoid being noticed lest their heads roll for having the audacity to make a decision or offer an out of the box idea.

The reward for e

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

Following aspects would a

mpowering the team and accepting those new uneasy solutions that the team creates will be astounding. For every one of those uneasy solutions, new creative solutions and ideas will surface that never would have seen the light of day. The true innovation power and problem solving ene

dd to the challenges in developing combination products:

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

rgy of all of the minds on the entire team will be unleashed. In this way the unique talents and brainpower of each team member allowed to develop and freely create without the constraints of fear, control, or humiliation.

Empowerment is what delegating is really all about. The spo

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

rts coach does not delegate the job of coaching to the players. Nor does the coach delegate the job of defining the mission and setting objectives. The coach does effectively delegate the job of each position on the team to the player who must execute that position.

Business leader

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

s likewise are not delegating the job of defining the mission and setting expectations – that is their job. The job that is being delegated to the team members is the actual work processes, projects, tasks, methods, and day-to-day activities required to accomplish the mission. The m

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

ssion becomes everyone’s purpose – leader and team member alike – but each plays their unique role.

Letting go of that control lever can be challenging, and it does require a leap of faith as accountability for specific tasks and processes is shifted to someone else. Start small. T

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

Professional from academic institutions, pharmaceutical industries, health care indust

his is a slow process of retraining both the leader to learn to delegate and the team to accept the accountability and freedom that comes with this new style. With each small step, both will gain more trust and acceptance and over time more steps, and bigger steps, can be taken with

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

more confidence.

Small detailed tasks that were previously dictated in great detail and monitored very frequently can easily be managed by someone else. Let them decide what to do next and review their progress next week. Agree on the objective or expected outcomes of the process,

.

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 let them get there. Of course, as a good coach would do, don’t forget to provide frequent encouragement, direction, guidance, and advice. Then enjoy the surprise as the team shows just how much they can accomplish.

Perhaps C. S. Lewis said it best: "It may be hard for an egg to

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

Companies that provide selfless information through particip

turn into a bird: it would be a jolly sight harder for it to learn to fly while remaining an egg. We are like eggs at present. And you cannot go on indefinitely being just an ordinary, decent egg. We must be hatched or go bad." The bird must be empowered to be a bird in order to fly

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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I also provide the client with the alternatives to Reverse Merger, such as Regulation D Offering, Direct Public Offering and private placement.

If your business involves selling a service, such as consultancy, you might find blatant advertising is counter-productive. After all, no-one wants to hire someone to help make their business more profitable when that other person is so obviously hungry for money! But you can't just sit back waiting for customers to find you; it simply doesn't work that way. You must get out there and drum up business yourself, based on subtle marketing methods that sometimes go unnoticed. But work wonderfully well, drumming up valuable advertising while costing little or even nothing. These neat ideas will get you started

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Advice You - Are You Still Doing it All Yourself

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