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Main Subject - Six Reasons to K.I.S.S.
Six Reasons to K.I.S.S.
“Very often, people confuse simple with simplistic. The nuance is lost on most.”
- Clement Mok, Chief Creative Officer, Sapient
We’ve all heard THIS acronym, K.I.S.S. – Keep it
“Very often, people confuse simple with simplistic. The nuance is lost on most.”
- Clement Mok, Chief Creative Officer, Sapient
We’ve all heard THIS acronym, K.I.S.S. – Keep it
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
Simple, Stupid! While I prefer, Keep it Splendidly Simple; the point is the same. Make it simple! All of us have heard the phrase. All of us nervously laugh and knowingly nod our heads when we hear it. All too often we don’t
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
follow this sage advice.
We’ve all heard the joke that a consultant is someone who will tell you about how to design, build and sell a watch, when all you wanted to know was the time. We are stereotyped often as people who l
We’ve all heard the joke that a consultant is someone who will tell you about how to design, build and sell a watch, when all you wanted to know was the time. We are stereotyped often as people who l
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ike to make things more complicated, if for no other reason, than to justify our fee.
While I don’t completely agree with the stereotype, as is usually true with these things, it contains a grain of truth. I believe we can ser
While I don’t completely agree with the stereotype, as is usually true with these things, it contains a grain of truth. I believe we can ser
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ve both ourselves and our clients better if we remember to keep our proposals, project plans, reports and other services more elegant (defined in my dictionary as, “ingeniously simple and pleasing, or excellent”), or simple. Here
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
are six reasons why we should strive to make simple one of the criteria for our work products:
1. Simple reduces errors. The more complex something becomes, the easier it is to make mistakes. Want your client
1. Simple reduces errors. The more complex something becomes, the easier it is to make mistakes. Want your client
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 implement your 18-step model? How likely will they be able to successfully navigate each step without errors or frustration? Not very likely. Which is of the following is more likely to succeed? A nine-page booklet of step
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 to follow in using the new software, or a concise job aid, that gives 80% of the users all the detail they’ll ever need, in a more usable format? (Even if you do need to provide the in-depth handbook, perhaps you need to write t
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
he job aid too!) When we design simple, elegant solutions, the error rate drops.
2. Simple is motivating. Simple plans give people confidence that they can succeed. When people understand the four key po
2. Simple is motivating. Simple plans give people confidence that they can succeed. When people understand the four key po
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
ints in your presentation, they are more motivated to apply them, because they feel like they have a fighting chance of success.
3. Simple is more effective. People are bright, but people have many things
3. Simple is more effective. People are bright, but people have many things
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
on their mind. When presenting findings to clients, we often have a 100 page report and a one page executive summary. The one page is probably too high an overview to lead to effective decisions, and how many people will actuall
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
y read your 100 page report? (When was the last time you read a 100 page report?). What clients need from us is the ability not only to analyze, or come up with the reams of data, but also the ability to synthesize, or draw toge
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ther the key elements in new and all encompassing ways. A simpler report can lead us to that. The simpler, five-pager, will force you to synthesize and provide the client with something much more valuable than the briefcase brea
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ker.
4. Simple saves time. This one is easy. It is common sense. When we make things simpler, we save time for the client (and ourselves in the long run). Enough said.
5. Simple brings fo
4. Simple saves time. This one is easy. It is common sense. When we make things simpler, we save time for the client (and ourselves in the long run). Enough said.
5. Simple brings fo
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
cus. Having one clear goal is easier for people to follow, than knowing the Nine Strategic Initiatives of the First Half of the Year. One is motivating, the other a hopeless clutter for the mind. I recently read, “When e
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
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
erything is important, nothing is.”. It hit home and helped my perspective about keeping it simple. If we want to stay focused, we have to keep it simple.
6. Simple is easier to sell. Being simple in our
6. Simple is easier to sell. Being simple in our
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
approach does not mean “quick and dirty”, or incomplete. Remember that simple and elegant can be synonyms. Would you rather buy an elegant, simple approach, or something very detailed and elaborate? Think about your answer bef
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ore you design your next consulting engagement.
A short comment in a recent Leadership Team meeting I was facilitating nudged me to write this. They were discussing a vision for their organization, and someone was talking abou
A short comment in a recent Leadership Team meeting I was facilitating nudged me to write this. They were discussing a vision for their organization, and someone was talking abou
.
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
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
t keeping things simple. They stated it as, “Sealed with a KISS”. I’ve decided to use that a criteria for all of our client work, and for internal efforts as well (even my personal projects!). Hopefully this piece has given you
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
pause to think about this concept, and accept my premise. My next article will focus on how to keep or make things simpler, but including those ideas now might clutter your mind. Until then, try “sealing things with a KISS”.
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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