Advice You - Business

One of great challenges for any business is to learn to efficiently and cost effectively leverage knowledge on an enterprise wide basis. We have all heard the saying that “knowledge is power”…we’ve all also heard the refinem

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

ent of that saying which states that “the application of knowledge is power”. I prefer to take it one step further and say that “the successful application of knowledge at the right time, for the right reasons and with the p

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

Examples of combination products may in

oper emphasis results in a certainty of execution that creates power.” In this blog post I’ll provide you with some insights that will help you to not only leverage your knowledge to increase returns, but also how to protect

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 knowledge to mitigate risk.

Let’s begin by defining knowledge management (KM)…While this alone may spur fierce debate, for simplicity sake I’ll define knowledge management as: “an organization’s ability to collect and

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

convert data into information, turn information into knowledge and knowledge into an operating advantage.” The operational advantage created through effective KM should allow an enterprise to effectively address current need

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

Combination pro

s as well as to strategically drive innovation and forward planning.

Put more simply, a corporation’s employees must be able to acquire knowledge (learning), transfer knowledge (out of the head and into an information syste

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

), apply knowledge (from the information system into an actionable event), manage knowledge (execute with focus, timing and precision), and secure knowledge (keep it from evaporating or even worse from walking out the door t

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

o a competitor). Let’s see if we can bring this issue a bit closer to home for some of you…Ask yourself the following questions:

Have you ever had a disruption in business continuity because someone who possessed a weal

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

h of experience and/or information retired, quit or was terminated?

Have you ever lost a deal or had a major operational problem because somewhere in your organization the right hand didn’t know what the left hand

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

was doing?

Have you ever found yourself in the unenviable position of desiring to terminate an employee only to be held hostage by the fear of losing the knowledge that they possess?

While I could go on ad-na

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

seum with day-to-day operating examples of how a lack of KM discipline can adversely affect a business I think I’ve probably dredged-up enough painful memories for now. Let’s turn our attention to the following 3 practices/c

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

Following aspects would a

oncepts that can immediately be used to implement a KM system for your business:

1. KM is more about people than systems: In order for KM to flourish in a corporate environment the business must value data, informatio

dd to the challenges in developing combination products:

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

, business intelligence, research and other forms of knowledge as a strategic corporate asset. Furthermore KM must be recognized as one of the core elements of your corporate culture. Encourage and reward the public sharing

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

of knowledge and education.

2. While KM is more about people and culture than systems, you still need a system: Start with developing standard naming conventions, file protocols, nomenclature and other heterogeneous s

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

andards that put everyone on the same system. By requiring everyone to work on the same platform and environment and within the same toolsets a certain sense of continuity and community is developed. Develop a mantra of “doc

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

ument, document and when in doubt, document” and make this as painless as possible. There is an old technology axiom that states “usability drives adoptability”. Whatever toolset you select must be easy to use so that it is

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

Professional from academic institutions, pharmaceutical industries, health care indust

iewed by employees as something that makes their job easier, not more difficult. That being said, there is a plethora of add water and mix intranet and KM solutions that are affordable and easy to use.

3. Protect your

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

corporate knowledge: All employees should sign work for hire, non-disclosure, non-compete and non-circumvention agreements that make sure that all knowledge developed will remain corporate knowledge. Furthermore make it a

.

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

ractice to utilize copyrights, service marks, trademarks, license agreements, patents and other intellectual property protections to protect the corporate investment into knowledge assets.

The bottom line is that you can ha

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

Companies that provide selfless information through particip

rness disparate elements of data and information and convert them into corporate knowledge assets to create a sustainable competitive advantage, or you can choose to sit back and conduct business as usual…The choice is yours

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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Unless they have extensive experience in commercial real estate, most small business owners are overwhelmed when they look for real property to buy or lease for their business operations. They may find it difficult to get good information.

In the United States of America some industries have been targeted as those most apt to hire illegal aliens and this is due to a long track record of abuse of exploitation of Hispanic workers and also of fines and violations. There are many such industries such as landscaping and carwashes especially. But there are many other industries on that list.

In this day and age it can become increasingly difficult to even get your foot in the door and get an interview; once you’ve accomplished that you will want to make sure you continue to put your best foot forward and nail the interview as well.

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