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If your organization has people, then interpersonal skills are needed.

I work with companies that are on a path

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

they call the lean journey. Whatever you call it, it’s based on the Toyota Production System. Some manufacturer

; 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 embraced it and it became known as Lean Manufacturing, expanded into the Lean Office or Lean Enterprise. Durin

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

g this transformation the approach became focused on tools, but Toyota’s approach is about people.

The focus of

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

Lean Manufacturing training has been on technical skills such as value stream mapping, 5S, and set-up reduction.

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

Combination pro

People skills; also known as “soft skills” or interpersonal skills haven’t been much of a priority. Difficulty

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

in moving from a traditional to a lean organization is usually blamed on the culture of the organization. If thi

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 is true than interpersonal skill training needs to be a higher priority. Communication often determines if the

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

transition succeeds or not. Could the “soft” stuff actually be more important than the “hard” stuff?

Somehow, m

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

any companies seem to believe that training managers to “create a vision” and engineers to map the value stream,

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

make work instructions visible and dictate how to clean and organize will magically transform the company.

How

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

Following aspects would a

ever, as we all know, it’s the people who do the work, not maps or set-up calculations. In a Lean organization,

dd to the challenges in developing combination products:

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

t’s the people who do the work that create the standardized work, not managers or engineers. In his book, The T

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

oyota Way, Jeffrey Liker explains, “it’s the people who bring the system to life: working, communicating, resolv

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

ing issues, and growing together.”

Toyota, on its website, states that “Improvements and suggestions by team me

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

mbers are the cornerstone of Toyota’s success.” Managers act as coaches and develop their people. Once again, le

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

Professional from academic institutions, pharmaceutical industries, health care indust

’s not forget, it’s the people who do the work. Continuous improvement is part of the work.

It’s easy to see (b

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

ut somehow difficult for some of us to embrace) that any organization can effectively follow Toyota’s lead. Mana

.

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

gers only need to coach and develop their people. Communication is the key. Interpersonal skills training, the “

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

Companies that provide selfless information through particip

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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