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E-Folder - Leverage: Systems
“Systemization” is one of the greatest sources of operational leverage. I would now like to explain this in detail. However, beware, this article isn’t for the faint of heart; you will have to pay close attention throughout. It’s not an easy read. On the other hand, systems are most definitely one of the greatest sources of leverage within an operational business; thus, I highly recommend the read.
First, what is a system? A
First, what is a system? A
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
system is a framework in which a routine process is carried out. This framework is a formalized set of procedures, tasks, controls, and measures which are utilized to carry out and complete a process in a desired manner.
Here is a common example: The hiring system which is a sub-system of the HR function. Other sub-systems of the HR function would include deployment, employee service, and so on. The hiring system is comprised
Here is a common example: The hiring system which is a sub-system of the HR function. Other sub-systems of the HR function would include deployment, employee service, and so on. The hiring system is comprised
; 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
f various procedures, tasks, controls, and measures which fulfill the system’s desired goal of effective recruitment. Procedurally, a business might solicit internal recruits for an open position; it might search for recruits outside the firm by creating a formal job description and distributing it through various recruitment channels. The potential hires from this external search might go through a pre-screening telephone interv
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ew, and thereafter go through an intensive one-on-one interview. The interview questions have been predetermined as well as the entire interview process—it is all formalized. Recruits are then measured objectively to determine compatibility and so forth.
The steps of this entire process has been predicted or experienced and from that knowledge and understanding, the framework is created. We all know this. This is the stuff the
The steps of this entire process has been predicted or experienced and from that knowledge and understanding, the framework is created. We all know this. This is the stuff the
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
teach you in operations management; more specifically, human resources management. Let me tell you, such knowledge gets you only so far. A business manager may know every single step and component of this process inside and out and yet the system may still perform inadequately or mediocrely under his/her supervision. How can this be?
This is the case simply because he or she doesn’t know how to leverage the system. In order
This is the case simply because he or she doesn’t know how to leverage the system. In order
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
o leverage a system, one must know and understand the ultimate goal of each component as well as the component’s relation to the whole. When this occurs, one spends the right amount of time on the right parts of the system for the right reasons, producing the right results, and it’s the right results that we want. When this is all understood, inefficiency is wringed out of the system. Actions that do not correlate positively to
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
the system’s improvement are eliminated. Actions that exponentially increase productivity and finally results are given close attention.
The great part of all this is that it’s all very very easy; one merely needs to think rather than perform the system duties absent-minded. I will now explain how one must view and understand various components of the hiring system in order to create leverage.
For the sake of brevity, let’s say
The great part of all this is that it’s all very very easy; one merely needs to think rather than perform the system duties absent-minded. I will now explain how one must view and understand various components of the hiring system in order to create leverage.
For the sake of brevity, let’s say
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
the chief components of the hiring system are as follows: Recruitment, Pre-Screening, and Interviewing. One will always find that the greatest leverage point, or fulcrum so to speak, is found at step no. 1. This is the point from which all other leverage flows. You will see what I mean in just a moment.
Recruitment: Step no. 1. Vitally important. Why so? Think about it (remember, no absent-mindedness). Imagine you get 10 r
Recruitment: Step no. 1. Vitally important. Why so? Think about it (remember, no absent-mindedness). Imagine you get 10 r
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
cruits for a sales position; the potential, a derivative of personal talent, of the sales position has just been determined. No matter how well you screen, no matter how well you interview, the performance of the hire will not and cannot exceed the performance level of the highest performer in the group of 10 recruits. On the other hand, let’s say that you get 30 recruits for a position. Probability tells us that there is like
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
y to be an individual or individuals in this group that exceed the talent level of the most talented individual in our group of 10. Once again, the potential of the position is limited to the talent level of the most talented individual, but it is no doubt greater than it was before. Of course, numbers are easy to work with and must follow the rule of relevancy which follows here. The ability to recruit the right individuals is
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
itally important. If you hire random individuals for a sales position, say 50 of them, you may not do any better than hiring 5 seasoned, experienced salespeople. Thus, as part of recruitment, you must focus on two things to maximize leverage: Numbers and Relevancy. And, of course, we could go into great detail how to achieve this, but you can do that elsewhere. Lastly, I want to mention another interesting fact about leverage
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
hich can be found in this step: It takes barely any more work to improve numbers and relevancy relative to the potential gain. This is a common trait of leverage; it will be found once again in the interview process.
Alright, so let’s say that we hired as many possible recruits as was appropriate, not too few, not too many; and let’s say that you did a very good job at recruiting individuals who were fit for the job. On to leve
Alright, so let’s say that we hired as many possible recruits as was appropriate, not too few, not too many; and let’s say that you did a very good job at recruiting individuals who were fit for the job. On to leve
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
age point 2 (which doesn’t have much leverage involved): Pre-Screening; let’s say that this pre-screening is a brief telephone interview. Now I’m not going to say much about this point because the amount of potential leverage has already been set. However, the important part is to get rid of the bad and keep the good, obviously. Do just the opposite, and well, you’re screwed. This step isn’t vitally important as it’ll simply he
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
p you in your next step, interviewing. Thus, the case will usually be that not as much time will be spent perfecting this step rather than the others.
Leverage point 3: Interviewing. And let’s assume that the interview decides who is chosen for the position. First, let’s look at one of the common traits of leverage found in hiring: Like recruiting, if you put a little more time and effort into interviews, the potential gain c
Leverage point 3: Interviewing. And let’s assume that the interview decides who is chosen for the position. First, let’s look at one of the common traits of leverage found in hiring: Like recruiting, if you put a little more time and effort into interviews, the potential gain c
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
n increase exponentially. The chances of filling a position with the highest potential player can be as low as 5% if you have a pathetic interview process (informal, subjective, etc). This means that the position is most likely to be filled with a mediocre player who will perform at such a level. Put a little more effort into the interview process, perfecting it, and all of a sudden your chances of picking the right person incre
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
ses greatly; and therefore, the productivity that arises from that position skyrockets—all for a little more work. That is leverage. Take one firm that places little emphasis on exacting the interview process and another one that takes it very seriously, and I’ll bet my life on the fact that the latter firm will win any head to head contest in the market. It will survive in the long run; the other will die. Once again, I want
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
o bring to your attention the fact that you will still only be able to hire the best recruit, no more. Thus, the better recruits, the better the potential final result.
Ok, so what I’ve just described is the hiring process or system (simplified). If the system is weak, the whole firm is weak. If the system is strong, the whole firm is strong (relatively). An increase in the effectiveness and efficiency of the system creates a
Ok, so what I’ve just described is the hiring process or system (simplified). If the system is weak, the whole firm is weak. If the system is strong, the whole firm is strong (relatively). An increase in the effectiveness and efficiency of the system creates a
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ultiple-fold increase in the effectiveness of the firm because the system produces numerous outputs, an aggregate, rather than one. And this is one of the key reasons why systems are absolutely vital and a huge source of leverage. This is especially true when you take in account all the systems of an organization as a whole. Systems are the pillars which support the firm. One weak pillar produces a weak whole.
Since these syst
Since these syst
.
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
ms are so important and, as a whole, create such leverage, it is very important to always be improving the systems; once again, this is because an improvement can create geometric gains over time. You can improve functions and tasks within the systems themselves, but the results can never exceed the effectiveness of the system itself—the potential of which is determined by leverage point one; thus, before inner improvement takes p
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
ace and improvement on leverage points that occur further down the system, it is usually more important to improve the system as a whole, focusing first on improving leverage point one and then every leverage point starting with the next most important. E.g. Improve recruitment before hiring. (This assumes they’re currently at the same level of effectiveness).
This has been a brief description of systems as a source of leverage
This has been a brief description of systems as a source of leverage
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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