MedTalk Pei is the show I record with the people who have already done it. Notified bodies, test labs, multinational managers, founders, clinicians. Different companies, and somehow the same lessons.
Every episode is also on video. Pick a guest whose problem sounds like yours.
I get to ask the questions I would be too embarrassed to ask in a meeting. Dozens of episodes later, the same three answers keep coming back.
It should be first. Roughly half of the products a consultant sees were built before anyone decided who would buy them.
A factory can work overtime. Cells in a lab do not grow faster because you are in a hurry.
Molding, sterilization, testing and regulatory work are four different trades. Nobody is good at all four.
BSI on ISO 13485 and IVDR. Alumni of Stryker, Becton Dickinson, Intel and Amazon. Founders of test labs, CROs, clinics and distributors. Taipei Tech and Taipei Medical University. SIDAM Group in Italy, and Silicon Valley in the US.
The guests are not selling to you. They are telling you what it cost them. That is the only reason this show is worth twenty minutes of your time.
“About half of our clients build the product first, then work out who is going to buy it.”
“You never try, you never know. So are you willing to take challenges?”
“ISO 13485 is not paperwork. It is the language a device speaks before it travels.”
I am second generation at Chi Feng, an injection molder in New Taipei City. I started this show because a customer once told me he thought we did not make a part we had been making for years, so he went somewhere else. He was not blaming me. He simply could not find us.
If you are not sure whether we make your part, send the drawing and ask. It costs you one email. It cost me a customer.