Main Subject - Business

Getting people involved in measuring and improving performance is one of the greatest challenges (and greatest enablers) in designing measures that le

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

ad to improvement. But just inviting them to a workshop, or telling them to come up with measures, rarely works. Here are my favourite ways to authent

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

Examples of combination products may in

cally involve people, in a way that has meaning for them.

Idea #1: ask them what their biggest obstacles are to doing their job well

What will get p

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

ople's attention more than talking about what bugs them the most? And what better a place to start involving them in performance improvement than in h

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

lping them improve what matters to them? Even if what bugs them isn't strategically important right now, it's a valuable exercise that will lead to th

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

Combination pro

m thinking more easily on what 'bugs the organisation' (the biggest obstacles to the organising performing well).

Idea #2: ask them to give feedback

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

on someone else's measures

Aside from the obvious value that comes from getting feedback from others, this approach makes it safe for people to start

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

getting familiar with performance measures, without feeling imposed. As part of my PuMP Implementer Program, we use a measure gallery as a way gatheri

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

g feedback from the wider organisation on the measures a team has just freshly designed. These measure galleries have been known to generate lots of i

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

terest in other parts of the organisation to further explore performance measures for themselves.

Idea #3: coach them as individual people, rather th

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

n facilitating or teaching them as a group

The group approach, where you get people in the room and walk them through designing measures, is certainl

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

Following aspects would a

y very efficient. But it can leave people behind - people that are worried about a problem on the job, people that are starting from less experience w

dd to the challenges in developing combination products:

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

th measurement, people that feel cynical about measurement ("It's just another big stick!"). Outside of workshop time, you may well need to share a co

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

fee or chat over the phone to support a few participants that are feeling less than committed to the process.

Idea #4: ask them why they aren't as in

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

olved as you'd like

Often we just assume that people don't care, or haven't got the time, or just have a bad attitude, and that's why they won't get

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

nvolved in measuring performance. (And you know what assumptions are, don't you?) Instead, just ask. Not everyone will feel confident to give you an h

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

Professional from academic institutions, pharmaceutical industries, health care indust

onest answer, but some will. And the conversation you can then have to explore their objectives, answer their questions, take on their ideas, could be

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

just the opportunity you need to get them more involved.

Idea #5: role model the design and use of great measures

Your actions speak louder than you

.

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

words. You can't expect anyone to get involved in something you aren't involved in yourself. So establishing a few great performance measures that wi

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

Companies that provide selfless information through particip

l help you improve performance, and then using those measures to make performance improve, can be a great way to show others the value of doing it too

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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