Summary - Self Improvement

Every day we deal with a variety of matters of urgent importance in our organizations. Seldom is leadership development on that urgent list. While perhaps not urgent, few things are of greater importance to the future of our organizations that the cons

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

cious and consistent development of our future leaders. Unfortunately, when we do put time and effort into leadership development, all too often those efforts fail.

In this article I will outline seven specific things you can do – as an individual want

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

Examples of combination products may in

ing to improve your leadership skills or when thinking about leadership development across an organization. Implementing any one of these suggestions will prove a valuable supplement to what you are already doing. Implementing most or all of them will

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

yield or more confident, competent and prepared leaders than your existing development efforts by themselves ever will.

The Seven Suggestions

Create opportunities for self discovery and to create desire.

Learning anything successfully re

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

uires a motivated and interested learner. This is especially true for leadership. Often leaders see themselves as technical experts. In many cases they have been promoted because they were good at their previous jobs – which may have had nothing to do

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

Combination pro

with leading. Leaders need to understand how influential they are and know how they are doing, what the gaps are and have a desire to improve. 360 Feedback processes are one way to raise awareness and create a felt need for improvement. While they can

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

be a powerful tool, the underlying purpose for their use is to create a clear desire for further development. However you accomplish this discovery and desire, it is critical to the development of greater leadership skills.

Set a goal / make a plan

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

.

Leaders, either on their own or with assistance, need to set an improvement goal – they need to have a clear picture of the areas they would like to develop. With a goal set, a plan can be put in place to move towards it. While this will often ha

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

pen during a training event, this goal needs to be in place before attending any training to maximize the value of that training.

Focus on strengths.

Too often leaders build a plan based solely on improving areas of weakness. While we certainly

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

want to improve in those areas, an equal amount of effort should be focused on enhancing and further developing areas of greatest strength. While there are several reasons for this, none are more compelling than the fact that less effort is required to

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

improve an area of strength or natural talent than to achieve similar levels of improvement in an area of weakness.

Find ways to learn.

Leaders can be challenged to look for a wide variety of learning resources – encourage them to look beyond th

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

Following aspects would a

e training workshops you might provide. Have them consider podcasts, websites, lectures, books, discussions with other leaders, finding mentors, working with a coach – the list goes on and on. Once people begin to look, they will see many ways they can

dd to the challenges in developing combination products:

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

learn.

Find ways to practice.

Learning the ideas and knowledge is one thing, but to become a more effective leader people must practice. Encourage leaders to integrate what they have learned into practice. Help them see that there are opportun

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

ities to practice everywhere – and not only at work. People will say they are busy – and they are. Challenge them to consider their leadership development as a integrated part of their work – among their most important tasks - rather than “one more th

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

ing to do”.

Get the leader’s leader involved.

Leaders can’t do it alone. Having the leader’s leader involved will help keep development as an important priority, but beyond that, the leader’s leader can provide coaching and help remove any obst

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

acles that might be in the way. Most of all, the leader’s leader can provide support and encouragement – two things that are critical when we are learning (and practicing) new skills.

Build systems organizationally to support the other six suggestio

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

Professional from academic institutions, pharmaceutical industries, health care indust

s.

We can do the six steps above as a motivated individual. But if we want to create a process for leadership development in our organization we have build ways to systematically provide people with the opportunities and options provided by the oth

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

er six suggestions.

What is Missing?

Notice that the suggestions above don’t talk about a training workshop, seminar or event as the key to your efforts. While you want any training you provide to be as useful and effective as possible, training

.

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

alone can only get you so far -which is why your current efforts are less effective than you’d like them to be. The seven suggestions above are meant to be an adjunct to your training efforts – to be a process to layer on top of your existing efforts.

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

Companies that provide selfless information through particip

Training alone won’t produce the leaders you need. It is one ingredient. The other seven suggestions in this article will, when added to a valuable, practical and effective training program, produce the leaders you desire – and your organization needs

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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