Subjects - Business

Effective use of competency frameworks provides employees with a clearly-defined set of personal development objectives and managers with a consistent measurement tool that could be used across geographical, cultural and work boundaries.

The concept is s

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

imple. To complete any task, people need to have the behaviour, skills and knowledge to undertake the task. Defining the behaviour, skills and knowledge (competence) to undertake a set of tasks (a job) and measuring the competence of people allows manager

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

Examples of combination products may in

s and employees to understand the gap between desired and demonstrated competence and develop a plan to close the gap.

Many organisations however fail in their attempts to build a framework to proactively manage competencies.

The major reason for failur

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

e is that competence frameworks are developed and implemented with no clear business purpose in mind. Without a business purpose, there is no objective on which to base design decisions as the framework is built. The resultant design is usually flawed, se

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

rving too many masters and is discontinued after a year or two of use.

Competency development frameworks built with a clear business purpose in mind suffer from other fatal flaws limiting the use of and belief in the framework. Frameworks built which con

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

Combination pro

use tasks with competency are usually complex and difficult to administer and therefore are difficult to communicate to employees.

For a framework to be successful, not only do managers need to believe that business performance will improve, but employee

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

s also need to believe that the framework, especially the measurement of competence, is fair and transparent.

A common fault of competency frameworks is that they confuse competence with task. Tasks are better positioned in the job description. Framework

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

s which confuse tasks with competencies generally have between forty and fifty "competencies" described. Each job description tends to have between twenty and thirty competencies to be evaluated in an employee.

In the early days of the internet, before p

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

eople were careful about what they put in the public domain, I stumbled across NASA's competency framework. It was huge with hundreds of listed "competencies" and resembling a list of all of the tasks that astronauts and the support staff do. It was doome

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

d to fail to deliver any business purpose other than being a repository from which to write the "tasks" part of job descriptions.

Competency development frameworks should have about twelve competencies to describe and measure to be successful in the long

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

term. Any more makes them difficult to administer and communicate. The competencies need to cover the range of behaviours, skills and knowledge required to complete the tasks undertaken by the organisation or section in question.

The difference between b

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

Following aspects would a

ehaviour skills and knowledge can be examined through occupations which require the driving of a motor vehicle.

Firstly, a courier driver requires the behaviour, skills and knowledge as follows.

Behaviour; the driver must be courteous, punctual and not

dd to the challenges in developing combination products:

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

too much of a boy racer in the traffic as we don't want to accumulate fines. Skills; must be able to drive a car, evidenced by a licence, read a street directory and able to use a hand held computer to access orders, make payments etc. Knowledge; must kno

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

w the road rules, again evidenced by a licence, our delivery and credit terms and our returns policy.

Secondly, let us examine another driver, a specific one whose name is Michael Schumacher. Herr Schumacher needs to have the following skills behaviour a

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

nd knowledge.

Behaviour; has ice cool nerves, steely determination and confidence in his ability to the point of arrogance. Skills; a much higher level of driving skill than our courier driver, a licence will not suffice as evidence, able to change gears

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

by pressing buttons and have reflexes measured in milliseconds. Knowledge; must know the racing line of every Grand Prix track, the relationship between track, tyre and suspension set up.

Designing a framework with competencies defined at different level

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

Professional from academic institutions, pharmaceutical industries, health care indust

s, eg driving ability in the above example, allows a range of jobs to be described using the same competency set. Typically, a competency framework will have between three and five levels of each competency defined.

If significantly more than twelve comp

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

etencies need to be defined to cover the range of jobs in an organisation, it is better to develop separate linked frameworks. The linkage comes through the behaviours and some of the skills. Behaviours are closely related to the values and organisation d

.

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

esires and therefore the requirement is likely to be the same in different functions. Some skills will also be the same, for example, communication. However, the knowledge requirement of different functions is normally quite different.

Good competency fr

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

Companies that provide selfless information through particip

ameworks will be easy to administer, easy to understand and built for a business purpose. Bad competency frameworks will confuse competency and task and be difficult to administer and understand and will have been built without an obvious business purpose

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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Subjects - Competency Frameworks; The Good, the Bad and the Ugly

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