In the last blog post where I talked about business models I mentioned that higher device classification, and ergo the increase in clinical evidence that comes with it, can lead to more sophisticated business models. These sophisticated business models are both a blessing and a curse. In most industries, the person who uses the product is also the person who decides to buy the product, and is usually the one who pays for the product. In healthcare, this is not the case. The person who benefits from the “product” (the patient) is different than the person who authorizes the “purchase” (the doctor or other healthcare worker) and is different from the person who pays (the payer). Furthermore, these business models are not only complicated, but may differ wildly from country-to-country, or even province-to-province. Understanding this specific relationship is instrumental in developing a business model in healthcare, especially one that involves reimbursement.
There are several different paths that you can take to have your product reimbursed, ranging from public or private payers, government programs, social assistance, charitable organizations and non-profits. The reimbursement strategy you chose will depend on the type of device you are creating. For companies creating mobility devices, the best fit is the Ontario Assistive Devices Program (ADP). If accepted, ADP pays 75% of the price towards the purchase of mobility and positioning devices for people who have chronic physical disability and meet the ADP criteria (see ADP website for latest criteria). Examples of the type of mobility devices ADP covers are power wheelchairs, crutches, power dynamic tilt devices etc. There are many small requirements that need to be met for ADP to consider listing the product, but the major requirements are:
One of the major drawbacks is that ADP currently does not list digital health devices or mobile medical applications as mobility devices. This may prove to be a bump in the road for companies who are trying to gain reimbursement for their device to help lower the cost for patients. However, if significant patient benefit can be shown through clinical testing and if the necessary support from front-line healthcare workers (for example occupational and physical therapists) is secured, it may be possible.
SENSIMAT Systems Inc.
910 Rowntree Dairy Rd. Unit 13
Canada L4L 5W5