We Practice Medicine Differently Here

[ or the "Not Invented Here (NIH)" syndrome ]

Going into new markets with a new medical solution (whether a medical device or a digital health software solution) involves several steps for dealing with barriers of entry. One of them is the topic of clinical validation.

It does not really matter to which country you attempt to go into, you will always get asked first where have you tried your solution and to show your clinical results. And it really does not matter what your response to that is as you should expect to hear the most frequently heard global response phrase: "Well, We Practice Medicine Differently Here".

You should not be alarmed or shocked at this statement as it just means that they want to do clinical validation by themselves. For that you need to identify a Key Opinion Leader (KOL) in the target market and attempt to work with him on doing a short pilot study to show him that the solution works also in their country. Then, once successful, to have the KOL give you a short letter stating that you have his stamp of approval that it works in that specific country. Once you have a local KOL make that statement no one can refute it.

With that letter you can then go onto the business side of things and start talking about market entry and distribution, once you have obtained the needed regulatory approvals / certifications with potential strategic partners.

I personally heard this statement in about 100 countries or more. From Japan to California  (yes California is a different country isn't it……….) and from South Africa to Argentina. Several countries have solutions for you to be able to do clinical pilots prior to getting any regulatory approval such as Japan where I have had done many of these swift clinical validation exercises.

The trick is to find the correct person to help you on the ground and to help manage the maze. To identify the correct KOL, to help implement the pilot study, to help interact with all involved to be able to bridge between you and those involved in Culture, Language and real meanings.

Now its time to make your plans how you achieve all of this in the shortest time period and with the least amount of expenses

Show me the clinical value and I will tell you how much you will sell

Rani Shifron is the managing partner at Healthier Globe, a global Digital Health and MedTech hub and a strategic innovation partner that scouts, builds, nurtures, secures funding and scales up Medical Device & Digital Health Startups, for further information please WhatsApp me @+972–54–688–0960 or email me at [email protected]

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