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Main Subject - Designing and Deploying Human Centric Processes
A lot of effort has been carried out in the last years to re engineer processes in order to automate all or parts of them. A great number of companies have changed their processes as a result of the introduction of new software systems, aimed to
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
streamline the management of the back and front office. Companies have even taken care of processes crossing the company boundaries in order to optimize communications with clients, providers and partners. A characteristic of this interest is that
; 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
is has been driven by technology.
In the last years we have seen the introduction of ERP and CRM systems, Content and Document Management systems, Workflow Automation Applications, etc... that have (or hopefully will) help companies achieve a mo
In the last years we have seen the introduction of ERP and CRM systems, Content and Document Management systems, Workflow Automation Applications, etc... that have (or hopefully will) help companies achieve a mo
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
re efficient use of their resources. It seemed that CIOs believed that an impressive IT portfolio would directly result in better processes.
However less interest has been directed at the human side of process optimization. A lot of money is spen
However less interest has been directed at the human side of process optimization. A lot of money is spen
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
t on paying a team from a world class consultancy firm, best of breed software products licenses, etc... and it is usual that the importance of deploying the new processes effectively is underestimated. Designing and documenting enhanced processes
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
does not create value for the company. It is only when these new processes are carried out in the real world that value is created.
If we use the popular metaphor that compares a business with an orchestra, you can have the best musicians (employ
If we use the popular metaphor that compares a business with an orchestra, you can have the best musicians (employ
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
ees) playing the best instruments (software systems) with the music scores (processes) in order. Value appears when they start playing together in a coordinated manner.
The objective of most Business Process Reengineering (BPR) projects is to inc
The objective of most Business Process Reengineering (BPR) projects is to inc
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
rease the quality of products and services produced, to lower costs, to reduce development time, to increase client satisfaction, etc... At the bottom line what you need to achieve is that people work in a new and more efficient way.
The success
The success
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
of a BPR effort, specially when process are carried out by people, is therefore highly dependent on people's understanding of the following concepts:
"Who does what, how, when and where"
Who. The person in charge of each task in the process must
"Who does what, how, when and where"
Who. The person in charge of each task in the process must
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
be clear. It must be clear who is accountable for each activity.
What. The characteristics that the output of the activity must conform to. The value it adds to the process object.
How. The way in which the task must be performed must be clearl
What. The characteristics that the output of the activity must conform to. The value it adds to the process object.
How. The way in which the task must be performed must be clearl
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
known and made explicit (documented) with the necessary level of detail. It is important that this set of descriptions and instructions are easy to update, so best practices and lessons learned can be incorporated and widely employed.
When. Whic
When. Whic
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
h activities precede and follow the task.
Where the activity is carried out.
The importance of efficiently deploying a process is also dependant on the number of persons that will be following the procedure. The greater the number is, the more v
Where the activity is carried out.
The importance of efficiently deploying a process is also dependant on the number of persons that will be following the procedure. The greater the number is, the more v
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
alue that an efficient deployment provides. Think of the claim processing department of an insurance company, people analyzing mortgage requests in a commercial bank or a big call center. These units normally have a great number of people executin
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
g the same process.
The objective is that people executing the process perform it as close as possible to the new version of the process, in the shortest possible period of time. These two variables are extremely important to generate value and t
The objective is that people executing the process perform it as close as possible to the new version of the process, in the shortest possible period of time. These two variables are extremely important to generate value and t
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
o recover the resources invested in reengineering the process.
Some of the practices that can contribute to this objective include making the procedures easily available in a format that facilitates its look up, training, controlling, incentivati
Some of the practices that can contribute to this objective include making the procedures easily available in a format that facilitates its look up, training, controlling, incentivati
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
g process compliance, etc...
But applying this techniques alone is not a synonym for success.
The real challenge is to get participant buy in. These is were social and cultural factors must be taken in to account, and change management, knowled
The real challenge is to get participant buy in. These is were social and cultural factors must be taken in to account, and change management, knowled
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
ge management, management of expectations, etc... come into play.
Experience has shown, especially with knowledge workers, that involving process participants in decisions that affect them, ensuring that they are well informed and making them fee
Experience has shown, especially with knowledge workers, that involving process participants in decisions that affect them, ensuring that they are well informed and making them fee
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
l that their opinion is being taken into account, is more effective than forcing them to follow the new processes. Although there are some cases were strict discipline must be used to enforce compliance with the process, it is usually better to re
.
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
ward good attitudes than to punish non compliance.
Once the process is being carried out following the new process it is also very important to enable feedback to the system. Process participants' opinions are extremely important to enhance the p
Once the process is being carried out following the new process it is also very important to enable feedback to the system. Process participants' opinions are extremely important to enhance the 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
rocess and it is likely that they have some good ideas to improve it. For example, performing a specific task in a way that can be institutionalized as a best practice, incorporated to the procedure and deployed to every participant in the process
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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