What Ethics Have to Do With Medical Technology Assessment
One of the reasons new medical technology undergoes assessment is to address potential legal and ethical concerns generated by the new technology. The last thing anyone wants is for a new treatment or piece of equipment to cause more problems than it solves, including setting off issues with rights, religious and social considerations, and more. The assessment helps researchers determine if the technology is worth putting into general use given what controversies or additional conditions it might generate.
Ensuring Patient Rights
How would the technology affect the rights of the patient? For example, if a piece of technology could give a person an early warning of a rise in blood pressure but does so by flashing a very bright light that everyone around them could see, that would most likely violate patient privacy. If a new treatment required a blood transfusion from family members but those members refused to participate, using the technology (and essentially forcing people to participate) would violate those people's rights. Those are two rather blatant examples, but needless to say, the technology has to be usable without violating anyone's rights.
Investigating Secondary Effects
Most medical treatments and equipment will have some sort of side effect, such as an injection making your arm a bit sore. But sometimes the technologies can also have secondary effects in which new conditions are created as a result of using the technology. These are still technically side effects, but they're the ones that become long-lasting or permanent, or that have damaging effects. For example, a medication that could heal a terrible infection could lead to permanent hearing loss (these are known as "ototoxic" medications). The assessment would have to weigh the benefit of healing the infection with the potential for that person to lose their hearing.
Verifying Success
The assessment also needs to verify that using the technology in a wider, real-life field will be successful. A technology that shows promise in controlled studies but no real success in real-life application, and also has bad side effects, may not be the most ethical thing to unleash on patients who are desperately seeking treatment solutions. It makes no sense from an ethical standpoint to subject people to technology that isn't going to help.
The assessment will take these and many other issues into account. If your company has created a new piece of medical technology, hire consultants to conduct a medical technology assessment to find potential issues with the technology early on.