-Always the possibility that complications/adverse events from use of NovoSorb may arise as more patients are treated with NovoSorb. Whilst clinical trials are meant to mitigate this risk, the increased sample size following entry to market of a medical device is the real test of safety
-Approval by regulatory bodies removed or not granted
-My sense is that medical professionals are risk adverse meaning they are reluctant to try new products on patients, consequently penetration into the market is always slow with new medical devices. Risk is that PolyNovo can not convince surgeons to adopt the use of NovoSorb
-Facility to manufacture NovoSorb is likley highly sophisticated meaning NovoSorb can not be produced anywhere and destruction of the facility by fire for example would cripple the supply chain
-NovoSorb likely needs to be sterile, contamination of the product and subsequent infection of the patient would critically wound PolyNovo