Advice You - Business

Change is always for the better. And I enjoy effecting change in organizations. It gives me a great amount of satisfaction to see the machinery - that includes people and processes - change to achieve a better level of operational excellence.

I have had considerable success in the numerous change managem

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

ent initiatives that I have led, however they have come with their own dose of challenges and associated learnings. As I reflect upon my past triumphs, there are 9 key steps - I call them mantras - that have ensured my success in all change management initiatives. The proof of the pudding lies in the fact that I have used these mantras successfull

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

Examples of combination products may in

y in managing and effecting change where such attempts had miserably failed. These are shared below for you to learn, adopt and adapt to your own unique environments & situations.

Mantra 1: Do not advocate the change from day 1

NEVER, NEVER, NEVER walk into an organization / a room and proclaim that you are there to make a change. Do that and

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

you / your efforts would be shown the door. Always position yourself as a facilitator who is there to work with them to see if there is a more effective way to do things. Mantra 2: Understand why the previous attempts had failed

To succeed, learn from previous mistakes. More importantly, understand why the previous attempts had failed. Di

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

ssect the cause to a great extent to get to the root cause of the failure. Get inputs from all quarters and people across the hierarchy to get about their views of why the previous attempts had failed. Now dissect the cause and arrive at your version of why the failure happened. This is what you will avoid at all costs. Mantra 3: Core team of key infl

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

Combination pro

uencers

Identify the groups that will be affected by the change that you are going to bring in. Now go into each affected group and find out who are the key influencers within them. This is the step that will define your success/failure. Create a core team with these people in it. Build a deep and trusting professional relationship with your core team. Get a view from

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

everyone of how the team should approach this challenge. Mantra 4: Least Common Denominator

Never try to force a process / model onto your core team. Rather, use your core team to first identify a least common denominator (LCD) i.e. the minimum that is acceptable to all affected parties. Thereafter evolve an elaborate model out of your LCD and bri

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

ng it to the final state that you have envisoned but not shared (remember, you are not supposed to impose but rather extract and evolve). Your role during this stage would be that of a listener and a facilitator. Mantra 5: Sell change to Sr. Management

Now that you have a blueprint for implementation, go ahead, show it to the Sr.

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

Mgmt. Do remember to include the names of people who have contributed to this and whose inputs have been taken into consideration. This will greatly increase your chances of getting a buy-in from the Sr. Mgmt. More importantly, listen and watch to the facial expressions and body language of the Sr. Mgmt team as you are presenting your case. Listen and understand their questions and answer t

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

o the point - there is no room for beating around the bush when it comes to the Sr. Mgmt. Own up for anything that you would have missed out and give a plan of action to incorporate their recommendations. NEVER leave the room without getting an in-principle agreement to your recommendations. If their suggestions warrant a major change, then schedule a follow-on session there and then and se

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

t expectations that that session would be to go over the suggestions and sign off on the approach. Do this and you have struck gold. And now you move on to rolling out the change. Mantra 6: Before rollout, identify noise-makers and address them

These are the people who could topple your applecart. Its easy to identify suc

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

Following aspects would a

h people - there are 2 types. Ones have a loud voice, sly smiles, have been in the system for a long time, have an opinion about everything and have the ability to influence their teams through brute force. The second type are passively destructive in the sense that they won't speak up at meetings, have a closed body-language and believe in working 1:1 with people and influencing

dd to the challenges in developing combination products:

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

them - to not subscribe to your recommendations. A two-pronged strategy to deal with such people includes 1)Selecting influencers as part of your core team and 2)Working individually with these people and pre-empting their concerns during such 1:1 sessions. Mantra 7: Roll out the change phase-wise

Slow and steady

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

wins the race - this applies to change management more than anything else. Look for quick-wins. Traget the most pro-change entities within the organization to effect the change first. This will help boost the morale of your core team. After the first success, take the most difficult customer as your next target. You will need full support from your core team and might have to get i

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

n the big guns at times. Succeed here and the rest of your work becomes a cake-walk. Mantra 8: Be lavish in your appreciation of other's contributions

Remember, this is not the first and the last change management initiative that you would be heading. So be generous in showing appreciation of oth

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

er's contributions. They will return the favour the next time they team up with you. Mantra 9: Enjoy what you are doing

This is the most important thing to do. Your enthusiasm about the change should be contagious. It should not only trickle down to the team but also bubble up to the Sr. Managemen

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

Professional from academic institutions, pharmaceutical industries, health care indust

t because they would be the influencers who would give you the required fire-power to effect the change.

My experience tells me that mantras these can be applied to any change management initiative - particularly if previous attempts have failed - with slight adjustments to cater to the uniqueness of the environment / situation.

CAUTION: Once you succeed in a major c

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

hange management initiative, you will be called in again and again. So be prepared. But believe me, each is a challenge in its own and you will enjoy it - in fact, it might get addictive.

Hope this helps you. God luck with leading change!!!

About the Author Shaju Nair is heading the Technology Competence and Consulting Division at a leading software products company in I

.

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

ndia. He has focused on the use of emerging technologies to differentiate products, processes and services and continuously seeks out opportunities for improvement.

Shaju has proactively acquired cross-industry, multi-geography experience with large multinational companies as well as silicon valley startups. His educational background includes institutions like Berkeley (International Busi

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

Companies that provide selfless information through particip

ness Management and International Finance), San Jose State University (Executive Business Programme - Executive MBA equivalent), University of California, Santa Cruz (Honors in Project and Program Management) and Gujarat University (Masters in Computer Applications). Additionally, he has written and published papers on various topics around technology, business management and brand building

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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