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It was a noble effort, even if I was naive. Last week I returned from a thirty-day trip to Germany, China, Singapore, Japan, Australia, and New Zealand. In each country, I led Skilled Facilitator workshops. Some of you reading this participated in these workshops.

For years, my clients have asked, "What do people outsi

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

de the United States think about The Skilled Facilitator approach? Can it work in Europe and Asia, especially given the emphasis on saving face? How?" I set out on my trip, naively thinking that I could come back with ready answers. I have begun to form some answers; but mostly, I have developed more questions. If I hav

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

Examples of combination products may in

e learned anything on the trip, it's that the issue of using the Skilled Facilitator approach in different cultures is a complex one. Mastering this topic in a one-month trip is about as realistic as expecting to master the approach itself in one month.

In this column, I'll share some of the things that my clients shar

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

ed with me and that made an impression on me. In future columns, I'll share some of the implications for using the Skilled Facilitator approach in different cultures.

First, people in every country I visited have been using the Skilled Facilitator approach to guide their work. This may not be a surprise to you, but it

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

was to me. There is a dedicated group of people in each country who are using the approach to inform their work, as facilitator, consultants, coaches, and leaders.

People from every country had concerns about using the Skilled Facilitator approach; almost all of these concerns were similar in kind (if not intensity) to

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

Combination pro

the concerns my United States' clients express. Although participants in every country didn't name "saving face" as a potential barrier to using the approach, participants in every country did use face saving strategies.

In Europe, a participant who works in Eastern European countries impressed on me that when citizen

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 in these nations used to share relevant information, sometimes they faced prison terms or worse. (This was similar to a comment my colleague Anne Davidson heard from our clients in the former Soviet Union). Fortunately, the other European participants in this workshop did not share this experience.

Participants in Ch

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

ina, Singapore, and Japan talked openly about the need to save face and at the same time how saving face creates problems. In one of my conversations in Tokyo, a colleague told me that because Japan is such a homogenous nation, managers expected that their direct reports are able to correctly make inferences without tes

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

ting them out. When I asked if this worked, she told me that it created problems. Making a gross generalization, among my workshops in Shanghai, Tokyo, and Singapore, my impression is that the issue of saving face was less an issue in Singapore. I don't know whether this was a function of the particular people in the wo

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

rkshop, my impression that Singaporeans seem to think of themselves as more Western than the others, or something else. Those of you with experience in Singapore and China and Japan: What are your thoughts?

In Tokyo, I conducted my workshop in English and it was translated - or more accurately, interpreted - into Japan

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

ese. I learned that in Japanese there is no word for "you" that is not offensive. If I'm going to test out an inference I'm making about you (and your surname is Teramura) , it would roughly be translated as, "Mr. Schwarz is inferring that Ms. Teramura thinks that Mr. Schwarz will be late delivering the report. Is Mr. S

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

Following aspects would a

chwarz thinking correctly?" I know the difference between the languages reflects deeper cultural differences; I'm just not sure yet what this example reflects. What do you think?

I also learned that, in Japan, if I'm testing an inference about you, it's "helpful" to frame it in a way that suggests that I was not so cle

dd to the challenges in developing combination products:

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

ver to think about this, but that you were the one to think of what I'm saying. This is one of the many ways that people show humility and respect to others. I still don't understand how you do this if you are the one testing the inference; but then I realize that my thinking is limited to both the English language and

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

the frames associated with it. In Japanese, it may be relatively simple. Japanese colleagues: please help me understand how you accomplish this.

One of my biggest surprises came in Australia (and was reinforced in New Zealand), when participants told me that Australians are reluctant to give positive feedback. They cal

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

led it "tall poppy syndrome": those who receive feedback stand up tall only to get cut down like the tall poppies growing in the field. When I asked where this notion originated, several participants told me that most Australians today were descended from convicts (the British sent their prisoners there), and people did

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

not like the idea of others acting above their station. I'm not certain whether the motivation to withhold positive feedback is to protect people from being subsequently being "cut down" or because they do not want people to feel better than others. Australian colleagues: please help clarify this.

In almost every work

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

Professional from academic institutions, pharmaceutical industries, health care indust

shop, I asked participants if they could use some elements of the approach in their work, and if they could adapt it effectively to use within their culture. Almost all participants thought they could even though the approach was countercultural. What I took from this is that people believe it was possible to honor the

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

core values and principles of the approach even as they adapt it to their particular cultural context. For example, in Tokyo, one participant told me that he believed it was possible to test inferences directly with a superior as long as he could convey the respect he had for the other person and could also convey his p

.

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

ure intent for testing the inference. To me, this seems like a combination of compassion and transparency. Still, I don't want to mislead you; the issue of saving face and protecting others does have a cultural layer in the Asian countries I visited that is not present to the same degree in the United States.

I had man

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

Companies that provide selfless information through particip

y more experiences, which I'll continue to share in future columns. I just wanted to give you some initial impressions. What are your reactions or own experiences about this? Please join our conversation at the Mutual Learning Action Group on using the Skilled Facilitator approach in Asian cultures.

© 2005 Roger Schwar

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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