The final guidance is part of the agency’s effort to provide better patient access to new devices via stronger and streamlined clinical trials.
Should your IDE device be reimbursed? FDA’s latest draft guidance will help CMS make the decision.
Billing in clinical trials has changed recently, so here is a summary of where it has been and where it is heading.
FDA recently released changes and updated guidance documents to its pre-market assessment of medical devices. Susan Alpert, M.D., Ph.D., Principal, SFA Consulting LLC, provides the perspective of the industry and offers suggestions on what can be done to improve pre-market risk management.
While safety and efficacy are prime drivers, a med-tech product’s form and its function have a much deeper and stronger relation than one might assume.
As a designer, it can be easy fall into the trap of focusing on and designing for the user. While this is all very good for the user, it’s not so great for the many other people who must interact with the product throughout its life. The intended user of a product is not the only user and there are a number of “stakeholders” in a product’s life.