Technical Risk Assessment
No early stage medical device is without risk. The technical risk assessment provides an independent analysis of the risks between where the project is today and a successful market launch. Technical risk assessments identify lower risk funding opportunities and establish benchmarks for future funding to ensure technical risk is being consistently reduced. This analysis provides a context for judging where technical progress reduces risk and where it does not.
Answering this question involves examining the planned design and the set of necessary components which the device will incorporate to ascertain the amount of novel engineering that will be necessary to bring the device to fruition.
For example, a next generation peristaltic pump is a straightforward implementation of technology that already exists; a next generation peristaltic pump that measures heart rate by monitoring variations in downstream pressure is novel and requires inventing a sensor capable of measuring downstream pressure more accurately than the current sensors can. Funding the invention of this hypothetical sensor is risky.
A technical risk assessment report on this new sensor quantifies the difference between currently available sensors and the sensor that the company would need to invent.
Additionally, it would describe the difference in the size of the signal the company is attempting to measure versus the noise in the pressure as a result of the peristaltic nature of the pump and head height variations. This will allow you to better understand the novel elements of the design and likelihood of making those in a commercial setting.
Does the technology to implement the device currently exist?
Medical devices are complex devices to design even when the design focuses exclusively on making a minimum viable product. The technical risk analysis will identify non-core features that have been added to increase the marketability of the device rather than its functionality in vivo. The minimum version of the device that would pass regulatory review will be identified and contrasted with the cost of adding non-core features prior to the regulatory filing. Similarly, the relative difficulty of adding each non-core feature back into the product after the regulatory filing will be assessed.
What is the simplest design that meets regulatory requirements?
Medical devices have different requirements than consumer goods, particularly around Electromagnetic Compatibility (EMC). Most consumer grade products could not pass medical grade testing for ESD, radiated emissions, water ingress, or clean-ability.
An example of this is the proliferation of home voice assistants. These products, while wildly popular for consumer user, would need the following changes to be a suitable medical device:
Two internal power supplies to prevent silent shutoff in the event of battery failure.
EMC hardening, not particularly difficult for a device where size is unimportant.
Improved security of personal data to comply with HIPAA. Two options:
Centralized model requires more robust privacy controls than currently implemented. This model also requires a loss of internet to not result in unacceptable risk.
Edge AI - lacks an ability to improve but prevents HIPAA violations by not collecting data. Also does not require an internet connection.
Access control - the speaker will need to only allow authorized users (like nurses and doctors) to perform clinically relevant actions and prevent users from manipulation. This ranges in importance from not very important for diagnostic tools to extremely important for opiod delivery systems.
Consumer products are allowed to stop working, sometimes shock users, break when subjected to abuse, get dirty, lose connection, power off, and be confusing while medical devices are not. Consumer products assume a healthy immune system and the ability of the consumer to protect themselves, medical devices have to assume a comatose immuno-compromised user who cannot protect themselves. Mild annoyances in consumer products would lead to recalls of medical products. This analysis will help you predict where these differences will manifest for a particular medical device.