They are not independent as you are manufacturing trying to point out. When you sell a HAD to the market you have regulatory requirements depending on each market that leads back to compliance issues on each level from manufacturing, component selection etc. When you do changes in your product you need to go through the approval process time after time particularly for a medical device.
When you develop a chipset you still have compliance but usually on function and specifications.
What I am saying is that it's a strategic direction that deviate from chipset manufacturing or OEM. What category you are selling your HAD you need to follow different standard. It requires usually a whole team to do this, compliance. The company is stretching them thin.
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