Advice You - Business

This third article in the series on Coaching Your Business to The Next Level Series.

Article #1 -- Top 7 Tips to Avoid the Top 7 Mistakes Small Business Owners Ma

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

ke. (See link at bottom of article to previous article.)

Article #2 -- Coaching Your Business to the Next Level Series Part 2

Assess Your Business

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

Examples of combination products may in

both Externally and Internally Mistake: Don’t presume that you know what is going on in your business. Take the time to assess your business both externally and

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

internally. Using an organizational assessment based upon proven criteria such as Baldrige may help you to focus o

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

n the directionally correct actions.

Many business owners resist assessments because they take time, cost money and potentially reveal what the business owner fears. And <

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

Combination pro

>FEAR in many instances is just False Evidence Appearing Real.

If you as a business owner, entrepreneur or department manager were to survey

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

your employees and ask them to list the top 3 goals for the company or department as they believe them to be, would you receive EXACTLY the same answer from each emp

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

loyee? As a small business coach who works with entrepreneurs to even large corporations, I have asked this question and have yet to receive exactly the same answers from al

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

l employees. The next question is the real shocker for the organization’s leadership. What are all of these missteps, misdirections, costing you?

To avoid these unintenti

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

onal mistakes, using an organizational assessment is one logical solution. The assessment should be have the following characteristics:

Based on nationally recog

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

ized criteria such as Baldrige

Be easily and quickly delivered such as via the Internet

Provide a paper based instrument if Internet is not available

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

Following aspects would a

i>Have a history of proven use (Customized solutions in many cases are expensive and build the income of the vendor at the expense of the client.)

Tailored to indu

dd to the challenges in developing combination products:

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

stry needs such as manufacturing, professional services, health care or education

Be affordable (Estimated range of $20 to $50 per person depending upon number of

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

employees for the instrument only. Analysis not included)

Include one on one confidential interviews to confirm or validate individual collected data using a cross

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

section of the employees

Provide a comprehensive report broken down by individual criterion, reporting groups, total responses and linked to current strategic pla

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

Be timely from collecting responses to delivering a final comprehensive analysis

Provide a simple action plan for immediate action

Include a d

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

Professional from academic institutions, pharmaceutical industries, health care indust

etailed debriefing between the decision-maker and the consultant

Can be replicated in one year as a check up

Assessments are indeed necessary to quick

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

ly turnaround current actions and to ensure alignment for all shareholders within any business or organization. By investing time to assess or survey where you truly are ri

.

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

ght now, will help you as the small business owner to executive avoid this second mistake of the 7 top mistakes<

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

Companies that provide selfless information through particip

/a> that many make. After all, would you agree to major surgery without a series of tests to determine what the real need is, then why should your business be any different

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

Understanding Dr. King's Messsage is key to understanding this holiday. It's about the American Dream and opportunity.

Business corporations are now facing one of the most competitive eras ever. With globalization and technology, businesses need to identify various areas for improvement in order to stay relevant.

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Advice You - Coaching Your Business To The Next Level Series Part 3 - Assessments

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