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Main Subject - How to Apply EMyth Principles to Your Leadership Role
Following on from a previous article on 'The EMyth Perspective' inspired by Michael Gerber’s book “The EMyth Manager,” I thought it might be useful to give you the overall context to this perspective and explain all 5 of Gerber’s EMyth principles.
Gerber believes that every manager should treat the organisation (or their part in it) as a small business and think o
Gerber believes that every manager should treat the organisation (or their part in it) as a small business and think o
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
f themselves as small business owners; so these principles apply to leaders and managers in any size organisation, as well as to business owners.
The first core principle is concerned with your life. Gerber believes (as do I) that you need to think of your business as a way of getting more from your life. Obviously in order to do that you need to know the purpose
The first core principle is concerned with your life. Gerber believes (as do I) that you need to think of your business as a way of getting more from your life. Obviously in order to do that you need to know the purpose
; 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
of your life, or have a vision of who you want to be and the kind of life you want to lead: Gerber describes this as your primary aim.
Once you’ve established this you can then ask yourself whether the organisation’s aim serves your aim, whether the work you’re currently doing allows you to fulfil your aim, whether your company is a place where you can grow and exp
Once you’ve established this you can then ask yourself whether the organisation’s aim serves your aim, whether the work you’re currently doing allows you to fulfil your aim, whether your company is a place where you can grow and exp
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
erience yourself becoming the person you want to be.
In other words, as a manager you must do the internal work first, the work on yourself that enables you to answer these questions, otherwise you might fall into the trap of accepting the organisation’s purpose as your own, committing yourself to it, fighting battles for it and progressing well. But you might wak
In other words, as a manager you must do the internal work first, the work on yourself that enables you to answer these questions, otherwise you might fall into the trap of accepting the organisation’s purpose as your own, committing yourself to it, fighting battles for it and progressing well. But you might wak
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
up one day and ask yourself “Who am I?” “Where am I?” “What happened?” If so, you’ll realise you’ve passively relinquished responsibility for creating your own purpose, your own vision, your own life! Your vision, or primary aim, once created will become your internal benchmark against which you make all decisions concerning life and work.
The second EMyth pri
The second EMyth pri
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
nciple is ojectivisation or objectivising the business; viewing it as apart from rather than a part of you. You must see the business as a way of 'serving' your primary aim as opposed to 'being' your primary aim. Obviously, this would be impossible if you’d not worked on the creation of your own vision for your life, which is why the principles are in this order.
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
This principle involves deciding on the purpose of the business, or its strategic objectives. This means viewing the business as if it was a product sitting on a shelf and competing for the customer’s attention against a whole shelf of competing products (or businesses.) Put another way, this has less to do with what’s done in the business and more to do with how
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
it’s done. The commodity isn’t important – the way it’s delivered is! Your business is your product.
You develop your strategic objective by asking “How will my organisation look? How will it feel? How will it work? How will it justify its existence financially?” Write your Company Story – the standards and character of your organisation.
Once you’ve done th
You develop your strategic objective by asking “How will my organisation look? How will it feel? How will it work? How will it justify its existence financially?” Write your Company Story – the standards and character of your organisation.
Once you’ve done th
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
s the tactical objectives will start to reveal themselves, because once you determine this is the kind of organisation, then it’ll follow that that is what we must do to manifest it. The strategic objectives therefore become the external benchmark by which you can evaluate your role as a leader or manager.
The third EMyth principle involves working 'on' the busine
The third EMyth principle involves working 'on' the busine
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
ss rather than 'in' it. This flows from the first two principles in that if you can see the business as apart from you, that your business is not your life, then you will recognise that the primary purpose of your life is not to serve your business, but rather the primary purpose of your business is to serve your life.
Once this is truly understood, you can go to
Once this is truly understood, you can go to
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ork 'on' your business rather than 'in' it with a full understanding of why it’s absolutely necessary for you to do so. This needs to become the central theme of your daily activity, the prime catalyst for everything you do going forward. It means stepping out, taking the helicopter view so that you can more easily see what work you’re currently doing, and whether
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
it is moving you towards the business you want, because your role is to create a business that manifests the strategic objectives.
Systemisation, by which I mean developing an integrated system that does the work of the business whilst the people run the system, is the fourth EMyth principle. Gerber advocates The Franchise Prototype model where you pretend your bu
Systemisation, by which I mean developing an integrated system that does the work of the business whilst the people run the system, is the fourth EMyth principle. Gerber advocates The Franchise Prototype model where you pretend your bu
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
siness is (or will be) the prototype for thousands more just like it (not almost like it, but exactly like it) i.e. you pretend you’re going to franchise your business! (Note I said pretend – you don’t have to, unless of course you own the business and you want to.)
This franchise prototype model must follow certain rules:
• It must provide consistent value to cu
This franchise prototype model must follow certain rules:
• It must provide consistent value to cu
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
tomers, employees, suppliers and lenders, beyond what they expect.
What could your prototype do to provide consistently outstanding value?
• It must be operated by people with the lowest possible level of skill (i.e. necessary to fulfil the function.)
How can you give your customer the results he wants systematically, rather than personally? How can you create a
What could your prototype do to provide consistently outstanding value?
• It must be operated by people with the lowest possible level of skill (i.e. necessary to fulfil the function.)
How can you give your customer the results he wants systematically, rather than personally? How can you create a
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
business whose results are system dependant rather than people or expert dependant?
• It must stand out as a place of impeccable order.
How can you create structure and order? How can you create a business that says to its customers, your people know what they’re doing; a business that says to your people, you know what you’re doing?
• All work in the model mus
• It must stand out as a place of impeccable order.
How can you create structure and order? How can you create a business that says to its customers, your people know what they’re doing; a business that says to your people, you know what you’re doing?
• All work in the model mus
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
be documented in Operations manuals. This is your bible for “How we do it here.” It documents the purpose of the work, the specific steps to be taken, and the standards relating to both the process and the result. It is crucial for your prototype.
‘How do you do it’ in your organisation?
• It must provide a uniformly predictable service to customers. Looking
‘How do you do it’ in your organisation?
• It must provide a uniformly predictable service to customers. Looking
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
orderly is not enough; the business must also act orderly – it must do things in a predictable, uniform way.
How can you ensure that what you do, you do the same way each and every time?
• It must utilise a uniform colour, dress and facilities code. The model must be thought of as a package for your one and only product – your business.
How can you package your
How can you ensure that what you do, you do the same way each and every time?
• It must utilise a uniform colour, dress and facilities code. The model must be thought of as a package for your one and only product – your business.
How can you package your
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
usiness as carefully as a box of cereal?
Building the prototype of your business is a continuous business development process and this is the fifth and last EMyth principle.
Business Development from the EMyth perspective consists of 3 distinct but integrated processes – innovation, quantification & orchestration. Innovation is the ability to create what could be
Building the prototype of your business is a continuous business development process and this is the fifth and last EMyth principle.
Business Development from the EMyth perspective consists of 3 distinct but integrated processes – innovation, quantification & orchestration. Innovation is the ability to create what could be
.
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
. Quantification is recording and truly knowing the numbers in your organisation, so that you can recall the relationship between one event and another and a string of events that follow the same action. Orchestration is organising the work into replicable systems for consistent results. (My previous article gives more detail on these 3 processes.)
So, from the
So, from the
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
EMyth perspective, and the principles described:
What is your primary aim? What are your strategic objectives?
In order to leverage your time you need to be analysing your daily activities and asking yourself :
"Am I serving my primary aim (purpose of life) through the fulfilment of strategic objectives (purpose of business) by the work I’m doing at this moment?
What is your primary aim? What are your strategic objectives?
In order to leverage your time you need to be analysing your daily activities and asking yourself :
"Am I serving my primary aim (purpose of life) through the fulfilment of strategic objectives (purpose of business) by the work I’m doing at this moment?
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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