Main Subject - Business

A few years ago, community volunteers working for Save the Children, an internationally recognized nongovernmental organization, made a clever observation. Helping Vietnamese communities in which child malnutrition was the norm, they discovered that a small group of very poor families were able to nourish their children against all expectations. All families in the community shared the same resources and the same socioeconomic status. Their limitations were the same. The community workers were fascinated by the apparen

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

t abnormality of the very small group. What did these mothers do differently?

They found out that in the anomalous group, every mother “was going out to the rice paddies and collecting tiny shrimps and crabs the size of one joint of one finger and adding these to the child’s diet, along with the greens from sweet potato tops. Although readily available and free for the taking, the conventional wisdom held these foods to be inappropriate, or even dangerous, for young children. Along with the addition of the shrimps/

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

Examples of combination products may in

crabs and greens, there were certain other positive deviant practices involving frequency of feeding and quality of care of the child. It was apparent that the use of these foods and practices constituted enough of a difference to produce a well-nourished child.”

A wealth of similar observations has been made, mainly by non-governmental organization (NGO) programs. They all fall into the same category of ‘positive deviance’. Although the term has its roots in sociology and social psychology, it is the NGO communit

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

y that has spread the concept around the world. Today there are hundreds of community and third world initiatives using positive deviance, many of them tackling the problem of child malnutrition, while others address HIV, family planning, prevention of human trafficking, etc. All these projects share the following characteristics:
(1) most of the solutions are already inside the community or the group;
(2) there is a focus on finding out what the ‘successful deviants’ do that makes them succeed; and (3) t

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

his knowledge is transferred to others.
A standard methodology based on these simple principles has been used by many in these now diverse projects.

‘Deviance’ and its opposite ‘conformity’ are terms used in social psychology to define levels of adjustments, adaptations or responses to norms, whether in a community, a group or a particular environment. Conformity as a mechanism is usually adaptive, that is, it allows us to become accepted in a group or part of it. It creates a sense of belonging, whether this is

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

Combination pro

something sought consciously or that happens by default. Conformity is sometimes visual; we adopt a special dress code, a way of talking or behaving, or other stereotypes of the environment where we live and work. Long hair in a group of long-haired people is a sign of conformity with the group but it becomes a sign of dis-conformity or deviance if you live surrounded by short-haired folk in gray suits.

The same applies for Friday dress-downs, a practice started in the US a long time ago in which workers are allowed

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

to wear casual clothes on Fridays and expected to wear suits or similar business dress throughout the rest of the week. Incidentally, what started as an idea of loosening-up sometimes became another form of tyranny. In this system, one is effectively forced to wear a particular form of uniform on Fridays, so the original element of partial unconformity became a point of conformity because people had to comply with a new rule. It would have been different if people were allowed to dress casually any time but that wasn’t

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 case. Fridays, in this ‘liberating’ system are as dictatorial as Mondays because both carry a conduct code. As I have observed many times, casual dress codes, far from creating diversity of clothing, have constructed their own kind of uniformity. A casual dress code for an off-site management meeting or retreat very often means that everybody wears the same polo neck, Dockers trousers, laced boat shoes and sunglasses as if ready to go to the golf course. But this is another story.

The word ‘positive’ associated t

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

o deviance seems an apparent contradiction. How can deviance be positive in the context of norms, following rules or playing by the book? But the findings of the Save the Children field-workers suggest that ignoring these deviances is foolish. I believe the applications of this concept to management are plentiful. Our organizations are usually designed to follow rules and norms, with plenty of processes and systems that one has to adhere to. After all, these process and systems ensure consistency of quality and homogen

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

eity in the way of doing things. They are there for a reason; they have been proven effective in reaching some goals, achieving particular outcomes or providing management with some sort of control.

Rule-breakers
Conventional wisdom says you would not run a company without rules, processes and systems, and without obliging people to stick to them. Although this is obviously something that breeds success in many places, the reality is that, in any organization, you find people who do not follow the rules or

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

the internal conventional wisdom. Some of them may succeed, others may fail. Some may be difficult to manage while others may just be a bit of a pain and others not difficult at all. Management attention is on the ones who follow, on the normative side of the organization, on the creation of an even more robust system in which processes can be followed by anybody and repeated again and again. Indeed, the term ‘creative’ has become an accepted way of describing people who do not conform fully or come up with unexpectedl

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

Following aspects would a

y different ways of working. So when we say that Paul and Mary are team players and very committed, we usually mean they conform to the norm. When we say that Peter is somehow ‘creative’, we sometimes do not mean creative but nonconformist, surprising, often cutting corners and eventually getting away with murder. I am of course exaggerating here to caricature the point.

What do we benchmark? We benchmark good practices, achievements, cost-effective processes and efficient ways of getting from A to B. We don’t benchma

dd to the challenges in developing combination products:

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

rk anomalies, deviations or non-conformity. We benchmark the perfection of the current reality to make it a far-better-more-of-the-same. We discard deviations from the norm and label them as defects, difficult people, anomalies, lack of quality, unconformity, non-compliance, etc.

So far, despite the appearance to some readers, I am not making any judgments, but just focusing my camera on the day-to-day life of organizations. Yes, companies need quality systems, rules of management, processes and procedures to follow.

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

In industries such as pharmaceuticals, regulators will provide an entire framework from which any deviance is punishable. It would be foolish to run a manufacturing department with no quality handbook or a regulatory division that doesn’t pay attention to the regulatory requirements.

But the language of conformity, compliance, standard processes and systems is pervasive. It has the ability to create two things: a sometimes false sense of homogeneity and control, which is by default associated with good management prac

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

tice, and blindness or rejection of anything else that doesn’t conform. We should pay more attention to the deviants, the ones who have created success in similar circumstances where others have failed; the ones who didn’t quite follow the rules but cut through bureaucracy and made it; the ones who are ‘different’ and still achieving or even achieving more. Why are they special? Can we learn from them? Can we transfer that learning?

I know this may create lots of antibodies in conventional management but I suggest tha

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

t positive deviance benchmarking, if we can call it that, has potential implications for learning. Let’s take change management, for example. It’s well acknowledged that the best changes come from inside, that is, when internal players drive the process, perhaps with external consulting help, but without the standard legion of MBA consultants doing the job for you. Any change management program that does not integrate the study of internal positive deviances, and deviant people, would miss out on great power. In other

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

Professional from academic institutions, pharmaceutical industries, health care indust

words, in some cases, the ingredients for Side order: positive deviance in generally malnourished Vietnamese communities meant some children had enough to eat change may not only be inside the organization, they may have already been experimented with by those who – whether frustrated with the system or not – have tried ways to solve problems, improve productivity, create innovation or, say, speed up product development, not by complying with norms but by bypassing them. If this is true, you can’t afford to fire these

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

people because they don’t comply – you should give them the job of showing what can be changed by not complying.

My rule of thumb is that the more rules and regulations there are, the greater the opportunity for positive deviance. At one end of my spectrum there is a theoretical organizational world with no rules, no deviance or deviant people because there are no clear norms. At the other end, a super-structured, highly normative environment characterized by rules and heavily mapped with processes and systems, creati

.

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

ng and highlighting the deviances more strongly. The more rules there are, the greater the opportunity to break them. Far from ignoring, dismissing, let alone punishing the rule breakers, we should look at them with the same diligence that the Save the Children volunteers observed the few surprisingly well-nourished Vietnamese children surrounded by malnutrition. Maybe there is something there that holds the clue for innovation, for moving forward fast, or for being more effective.

If you are in charge, by all means h

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

Companies that provide selfless information through particip

ave your quality systems in place, your standard processes and systems, your standard operating procedure, your benchmarking department and your well-crafted world of rules. I hope, above all, that you care about something deeply if you insist on non-negotiable rules and behaviors for people. Positive deviance detective work, however, may provide clues for the future that no quality system, SOP system or cook-book system may ever give you. Benchmark deviance with the same diligence that you benchmark norms. It pays off

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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