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If you’ve ever felt stranded as an entrepreneur with an abundance of experience in some areas and a definite lack of experience in others, you’d be a perfect candidate for a Master Mind group. These groups have existed for thousands of y

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

ears, but the phrase ‘Master Mind’ was made a common reference in business circles by Napoleon Hill in his book, “Think and Grow Rich”.

With the onset of entrepreneurship in the twenty-first century, many people are walking out the door

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

Examples of combination products may in

of the traditional office environment and into the realm of self-employment. However, along with all of the benefits of entrepreneurship come some of the following challenges:

• Insecurity

• Too Many Distractions

• No External Accoun

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

ability

• Lack of Collaboration

Enter the Master Mind group. This is a group of mutually supportive, mutually accountable professionals that realize the value of collective thought and of caring, but firm accountability. They meet regu

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

arly to review goals and achievements along the path to those goals. They provide input, insight and critique that strip away the polish of each other’s plans. They then closely examine the supporting evidence to ensure that success is a

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

Combination pro

sured rather than hoped for. They share ideas freely, realizing that collective thought is far greater than the ideas of any one individual.

Some see these groups as simply Lead Sharing opportunities. But those that take this approach m

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

iss the tremendous benefit of insight that a true Master Mind group can bring. As an entrepreneur, leads for people who need your service are a tremendous asset. But the benefits of lead sharing groups are limited. Learning to develop le

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

ds through brainstorming, developing a laser-focused presentation of your benefits and keeping your life in balance through the feedback of all the group members is much more beneficial than a simple leads group.

How many people

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

should a Master Mind group contain?

The Master Mind group should be large enough to provide input in every area of life. The collective group should contain a balance of experience and focus in the areas of:

• Personal Finance

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

• Accounting and Business Records

• Relationships

• Marketing

• Sales

• Personal Health

• Human Resources

The group need not have professionals in each of these areas, as this group is no substitute for Professional representation

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

But someone in the group should have experiences in each of these areas that they can share and ensure that any plans of their fellow members can withstand scrutiny in these areas.

Many groups have reported that the ideal size they’ve

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

Following aspects would a

found was from four to eight members. Groups with fewer members sometimes find that one person tends to become the Alpha personality and the group loses its benefit. Those with more members find that schedule conflicts become a challenge

dd to the challenges in developing combination products:

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

and the group is never complete.

How often should the group meet?

Because there are a lot of action commitments made in a Master Mind group, the ideal meeting frequency is once a month. Should you join a group, be prep

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

red for a lot of ‘cramming’ to get your commitments completed by each meeting. Monthly meetings come around all too frequently. But it is a tremendous motivator to a entrepreneur to have that external motivation to be accountable.

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

g>What should my group meetings cover?

Master Mind agendas can vary as widely as the people that make them up. Typically, the group chooses certain areas of their lives they want to focus on. Then, each member presents their pe

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

sonal plans to reach their goals in each of these areas. Other members:

• Offer feedback as to the viability of the plan,

• Discuss ideas to improve the overall action plan,

• Explain the resources needed that aren’t discussed in the

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

Professional from academic institutions, pharmaceutical industries, health care indust

plan, and

• Offer access to resources to help their fellow member reach his/her goals.

Each member commits to action steps they will take during the next month to help them move toward their own goals. Then, they become accountable to

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

he group to meet those commitments by the following month.

Whether you are a budding entrepreneur or a seasoned veteran, you owe it to yourself to put your own Master Mind group together. If you plan to see your business grow beyond you

.

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

experience and the fee-for-service advice of your professional counselors, this wealth of experience on demand could be exactly what your business needs to take it to the next level.

So, make a list of the key people that you feel woul

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

Companies that provide selfless information through particip

compliment your weaknesses and that could benefit from your strengths. Now, pick up the phone and call them today. Schedule the meeting that will definitely expand your view of your business and your understanding of business as a whole

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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