Our company has a high impact product called the MAC System that is cleared by the FDA for both the hospital and at home.  At the moment, we are only selling in the hospital because that is where the domain knowledge is with the current sales team assembled.  We understand there is revenue to be made at-home, quite significant revenue, however reimbursement and product acquisition post-hospital stay is a complicating challenge.    There are also rental vs. buy business model decisions that need to be considered as well for the home market due to reimbursement headwinds.

- Gaining a firm understanding of the reimbursement landscape will be a key driver.  There is a process of obtaining our own reimbursement code from CMS, so further research on timing, duration, cost and anticipated reimbursement received will be a critical factor to setting up the financial model for the at-home market.  

- The Rent vs. Busy decision for our device is another issue needed to address.  If the above-mentioned reimbursement isn't possible or the reimbursement amount is minimal, we may need to find alternative ways to capitalize on the at-home market which would be achieved via renting rather than buying.  Our device includes a capital and a consumable.  The idea would be to possibly rent the capital and bill for only the consumable straps, but we would need to make sure we still account for our costs and have a favorable margin to substantiate the overhead required to maintain this program.  This would include shipping, disinfecting, reprocessing, re-packing, and billing.   Additionally, there is concern about retrieval of the capital and minimizing lost hardware. 

- Would reimbursement headwinds become more manageable if we were if we were able to connect our device at home via an app to show insurance companies the utilization and wear-time achieved by patients? It is possible that this could give confidence to drive reimbursement similar to the way C-PAP machines work.  Insurance doesn't want to pay for a product that isn't being used.  If the patient doesn't use it then the patient wouldn't get reimbursed.  We believe that we could model our use similar to the C-PAP machine.    Further research is needed though to validate that model.   

A scalable and launchable business plan that would generate a clear sales channel for the at-home market and model with favorable margins and returns.