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If your company is at a point in its history and experiencing solid growth where you are considering looking for outside investors for your capital needs, then you want to know

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

if your business will be or can be attractive to investors. If you plan to search for equity investors, you should know that they will expect a significant return on their inve

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

Examples of combination products may in

stment (20% to 50% is not uncommon) and many times within 5 years. These investors will look carefully at the candidate company to characteristics that include, but are not lim

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

ted to: a solid and proven management team; potential company growth; solid business plan; and evidence of strategic thinking and planning in a strategic plan with vision, miss

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

ion core values and short term & long term goals.

And the equity investors will expect you to give up a portion of your business. So, one needs to carefully consider: Do I ne

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

Combination pro

ed equity investors as a source of capital to grow the business? If you decide to obtain equity financing, here are 5 major actions you will need to take and probably in this o

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

der (although they can be done simultaneously to some degree):

1. Build a trusted advisory team. Select an attorney, accountant/financial advisor and business coach to build

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

that team. This advisory team will be a key resource to your business and will help you develop your business plan, guide you through this process, provide introductions to key

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

contacts and networking for you.

2. Develop a strategic plan and a business plan. The strategic plan includes the vision and mission for your business, along with the core v

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

lues or guiding principles of your business and the short & long-term goals for the business. The business plan is the action plan and will include an executive summary, your b

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

usiness strategy, a SWOT analysis, market research, financial projections, etc. My advice is to try to find out what the investors like to see in the business plan and customiz

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

Following aspects would a

e it and tailor it to their needs.

3. Determine the value of your business. You will need t enlist a professional to assist in this and would recommend that you seek referral

dd to the challenges in developing combination products:

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

from your advisory team as to who may best be prepared to do the valuation.

4. Network! Again, use your advisory team for contacts. There are many investors in the network

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

that are not “publicly” known or advertised or that only work from referrals from trusted sources.

5. Interview and select an equity partner. Carefully plan for an interview

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

process and use the talents of your advisory team again. Prepare a list of questions to ask each prospective investor. Explore multiple revenue sources to get the best deal.

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

ou want to find the best personal fit and the best business fit when selecting the equity partner.

You will need to “keep the faith” and not get discouraged in your pursuit, as

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

Professional from academic institutions, pharmaceutical industries, health care indust

you will encounter disappointments. My advice is to use those disappointments as a learning tool and to identify the “lessons learned” in each disappointment. Use strategic t

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

hinking and planning to re-write parts of your business plan if necessary or to develop specific aspects of your business. Always stay focused on your vision, mission and goals

.

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

for your business. And always remain patient, persistent and positive in your search!

If you want to learn more about what resources are available to entrepreneurs and busines

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

Companies that provide selfless information through particip

s owners looking for investors and other insights into this process, please contact Glenn Ebersole through his web site at www.businesscoach4u.com or by email at jgecoach@aol.co

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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Consulting Vs Selling, How we can make sales by not doing selling but consulting. As we know, everybody loves to buy but hates to be sold. We need to engage in non-manipulative selling, and ask deeper questions that will make the sale.

The sales training professionals need to insure that their sales force can handle interrupted phone calls without losing their train of thought and without being upset or irritated at the prospect.

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