Assoc. Dr. Kazibe Koyuncu (Turkey)
Assoc. Dr. Kazibe Koyuncu (Turkey)Medicana Kadıköy Hospital

Jan-Paul Roovers and Astrid Vollebregt conducted a wonderful discussion on the journey of product development. A practical innovation could be defined as safe and effective and should be cost-effective. The journey starts with the constitution of the prototype of the device. Then the device is improved with analysis and measurements. The device goes through deliberate experiments if  possible. Once the prototype is ready, the safety of the device when used in humans is tested with ex-vivo studies. Then learning curves are established and the data of the device is collected by larger studies or randomized controlled studies.

Also, new surgical operations can be criticized as they lack evaluation using an RCT. An ideal surgical operation should be designed using the IDEAL framework. IDEAL stands for idea, development, exploration, assessment, and long-term monitoring. At each stage of the IDEAL, key questions should be asked. At stage 1, the key question is, “What is the new treatment concept? “; at stage 2, the key questions are “Have we perfected and stabilized it? and “Can agree on what it is and who should get it (for the purposes of an RCT)?” The stage 3 key question is “ Is it better than current practice?” and the stage 4 question is “Are there any surprises?” Using the IDEAL framework provides both ethical and practical superiority. One of the most important ethical advantages is the reduction of adverse effects of the new procedure. In healthcare innovations, there are 4 key questions to be asked in order to have a successful outcome. These questions are:

  1. What exactly is the innovative “product” to be evaluated?
  2. How does it fit in the (existing) healthcare landscape?
  3. Whose perspectives and values need to be addressed?
  4. What is the stage or Technology Readiness Level (TLR) in the product life cycle?

Also, after marketing, post-marketing surveillance is done by regulators like the FDA. The FDA has the authority to issue recalls and safety alerts to correct or remove the devices from the market.