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Advice You - 20th Century Business Methods are the Problem Not the Solution
Throughout the 20th century, various methods for operating and developing the business have been contrived and refined, becoming the conventional methods that we use today. We improve management and effect business change by overlaying new contrived methods on the
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
existing methods in place. Even with all the improvements, we continue to have fundamental problems with re-organizations, intangible assets, cost control, alignment, etc. We are still looking for the one right way to organize and manage the enterprise.
Over the p
Over 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
Examples of combination products may in
ast decade, we implemented breakthroughs like business process re-engineering, business transformation methods, and enterprise resource planning. But, these turned out to be just new names and methods to do the same old things.
Why are there so many different ways
Why are there so many different ways
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
to do the same thing? Why isn't there just one right way? It is simply because all of these different ways are wrong ways, and we do not know the one right way. Since all the different ways we do things are wrong, we can only define the right ways by identifying 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 wrong ways that are generally-accepted. The basis for our management methods is not that they are the fundamentally-sound and understood right away, but that they are the generally-accepted wrong way. When we come up with the one right way, it will be known and
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ccepted, and all of the wrong ways will be obsolete.
Since the beginning of business, no one has ever stopped to think, "Is the way things have always been done the best way". What we do is to accept the way that things have always been done as the basis and try t
Since the beginning of business, no one has ever stopped to think, "Is the way things have always been done the best way". What we do is to accept the way that things have always been done as the basis and try t
ucts have become life saving products for the pharmaceutical companies who doesnt have many innovative molecules in their product pipeline and have been inc
o improve the way that things have always been done.
New business methods contrive ways to alleviate the symptoms of fundamental problems inherent in the way things have always been done. This we can do ad infinitum without ever solving the problems. How many meth
New business methods contrive ways to alleviate the symptoms of fundamental problems inherent in the way things have always been done. This we can do ad infinitum without ever solving the problems. How many meth
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
ods do we have and how many books have been written about corporate governance, business organization, change management, investment management, capital development, performance management, cost and value management, solution alignment, intangible assets, business
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
collaboration, etc. Why do we keep coming up with new methods, if previous methods were supposed to have solved the problem?
Management improvement books are written using the existing body of knowledge or published record as the valid basis. Many of the books cut
Management improvement books are written using the existing body of knowledge or published record as the valid basis. Many of the books cut
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
, reorganize, and paste what has already been written. Other books describe innovative ways enterprises are coping with contrived methods. These approaches prevent new breakthroughs and can, at best, produce some incremental improvement.
The problem is that conven
The problem is that conven
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ional business organization and management methods do not organize and manage the business. Instead we contrived methods to organize and manage people, departments, functions, activities, duties, positions, tasks, and numerous other entities. Each method defines th
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ese entities in its own way. Each method is a overlay on the business that obscures business reality and compounds the problem of change.
We need to step back and take a completely new look at the basics of our business enterprise and build the one right way to or
We need to step back and take a completely new look at the basics of our business enterprise and build the one right way to or
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ganize and manage the business.
Conventional methods manage contrived entities, but fail to specifically identify and manage the only two entities that define the business and must be managed:
- Results: Specific economic outputs produced at any level from busine
Conventional methods manage contrived entities, but fail to specifically identify and manage the only two entities that define the business and must be managed:
- Results: Specific economic outputs produced at any level from busine
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ss performance
- Performance solutions: Specific invested capital utilized to produce specific results
These two entities are used in Result-performance Management (R-pM) to organize the enterprise. Any other entities used must be defined in terms of results prod
- Performance solutions: Specific invested capital utilized to produce specific results
These two entities are used in Result-performance Management (R-pM) to organize the enterprise. Any other entities used must be defined in terms of results prod
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
uced and performance solutions utilized.
R-pM is a new breakthrough that defines the results that enterprise management wants to produce and adds and deletes results as needed. R-pM defines the capital utilized in performance solutions, to show how costs are incur
R-pM is a new breakthrough that defines the results that enterprise management wants to produce and adds and deletes results as needed. R-pM defines the capital utilized in performance solutions, to show how costs are incur
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
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
ed. R-pM deploys solutions to be utilized to the results to be produced to show total performance costs against the result value created.
R-pM manages the enterprise in three dimensions for ongoing advantage
- Result: Manage economic output to reach revenue goals
R-pM manages the enterprise in three dimensions for ongoing advantage
- Result: Manage economic output to reach revenue goals
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
- Performance: Manage invested capital to reach profit-margin goals
- Management: Manage operations and development over time periods to reach return on investment and strategic value goals
R-pM develops new performance solutions over time to create value in ne
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
w results. R-pM governs the enterprise over time to create strategic value.
By organizing and managing the business, R-pM eliminates unsolvable performance problems, such as re-organizations, intangible assets, misalignments, ad-hoc development, change management,
By organizing and managing the business, R-pM eliminates unsolvable performance problems, such as re-organizations, intangible assets, misalignments, ad-hoc development, change management,
.
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
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 unknown costs. R-pM enables strategic value creation, result value-quality chains, transparent governance, beneficial development, result-performance optimization, business collaboration, consulting professionalism, solution-sharing, and many other advantages
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
prevented by contrived methods.
When we employ R-pM, we have the one fundamental right way to organize and manage any enterprise for the 21st century. We can then get rid of all the obsolete wrong ways and eliminate the unsolvable 20th century problems we all face
When we employ R-pM, we have the one fundamental right way to organize and manage any enterprise for the 21st century. We can then get rid of all the obsolete wrong ways and eliminate the unsolvable 20th century problems we all face
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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