Operating Theory · Sep 10, 2026
Where the device thesis should be rejected
The rejection criteria, written before we get attached to anything. Novel materials, exotic sensing physics, sterile manufacturing, life-sustaining risk, and trial-scale evidence requirements all put a category outside this thesis.
Under the pillar Consumer tech for medical grade devices
The criteria
Reject when the device requires novel implantable materials or a difficult biological interface. Reject when the sensing physics has no commodity equivalent, which is the case for continuous glucose monitoring, where the sensor chemistry is the device and no phone contains one. Reject when precision requirements exceed what commodity parts can hold over the device life. Reject when manufacturing is sterile, single-use, or implantable. Reject when energy delivery is unusual. Reject when the function is life-sustaining and failure is fatal. Reject when the claim needs a prospective clinical trial.
The reimbursement rejections
Two more, from the payment side rather than the engineering side. Reject when the category is in competitive bidding and the price already sits at the floor, because a cheaper device wins nothing. Reject when the supplier is effectively paid for documentation and enrollment rather than for the device, because in that market a better device is not the constraint.
Why writing these down first matters
A research program that never rejects anything is marketing. The rejection list is what makes the acceptance list mean something, and every category we close with a reason makes the next screening faster.