TSO3 Competitive Advantage The short report by Spruce Point Capital Management indicates that TSO3 has no real competitive advantage over its incumbents and uses its own FDA Filing (510(k) - Indication for Use - IFU) to "prove" it.
While I believe the lack of transparency in placements is a hinderence and has merit, there are a few key rebuttals with regards to competitive advantage:
- A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device. In laymen's terms, the FDA Filing is meant to highlight how it is equivalent to exisitng approved devices, not a means of comparing competitive advantages.
The short report paints a picture of no competitive advantages at all. However, I believe there are 4 key competitive advantages of TSO3 VP4 which are as follows:
- Mixed Loads Capability: This removes the need for sorting instruments by hospital staff members. VP4 is the only low termperature sterilizer that can process mixed loads in the SAME CYCLE with load weights up to 75lbs. The advantage is that it reduces labor costs and maximizes productivity from increased throughput capacity.
- Single Cycle: This means that you don't have to put in another consumable part way-through and/or select the right cycle based on the particular instruments that need to be sanitized. Reduces the amount of staff training and human error which can lead to lawsuits.
- Dynamic Delivery of the Sterilant: Other hydrogen peroxide sterilizers deliver fixed doses of the consumable regardless of load size (i.e. 25lb or 50lb will use the same amount of sterilant). This wastes consumables. VP4 is the only dynamic system which essentially adjusts the quantity of injected sterilant based on a multitude of factors including load type, weight & temperature.
-Sterilizing Endoscopes with > than 2 channels: All of TSO3's competitios are only able to sterilize up to 2 channels.I want to highlight that all of the OEMs (Olympus,Pentax, FujiFilm) have partnerd with TSO3 for validation data for sterilization of duodenscopes based upon its ability to sterilize 4-channel colonscopes using the VP4.
The short report also mentions VP4's placement at the bottom of Getinge's product list. Notice how the first Getinge Product's are not available for sale in the U.S. (probably due to no FDA claim).