Hello, my name is Christine McDonough. I'm Assistant Professor in the Departments of Physical Therapy and in Orthopedic Surgery at the University of Pittsburgh. It's possible that commercializing a product intended to improve or support a human's health or medical condition has put you into a product category that will require complying with regulations for medical devices. Understanding these regulations is an important step for increasing your chances of success in your overall commercialization plan. Additionally, whether or not you are developing a medical device will affect the products ability to be paid for through health care reimbursement. Let's begin with the United States Food and Drug Administration or US FDA's definition of a medical device. For our purposes, we'll simplify it. The FDA defines a medical device as an instrument, apparatus, or other device that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in humans or other animals. The FDA's primary focus will be in reviewing the safety and effectiveness of your product. This includes the safety risks your product may impose on users or in claims about the effectiveness of your product that may or may not be supported by medical literature or appropriate testing. For the full definition with specifics related to combinations with pharmaceuticals and software, visit fda.gov or use the resources that I've included in your module after this video. If you're marketing the sale of your product in the US, the FDA will be a major regulatory body. Depending on the technology and other factors, it may be necessary to comply with other regulatory bodies even if what you are developing is not a medical device. This can include federal regulators such as the Federal Communications Commission or FCC, or industrial standards developed by the International Standardization Organization, ISO or the International Electrotechnical Commission, IEC to name a few. Similar to the US, the European Union and other countries may have regulations specific to medical devices or technologies that emit radiation or communication frequencies. We will not be covering these in detail in this video, but a treat webinar has been provided in the module resources for more information if you believe any of this applies to you. Specific to the US FDA, a good place to begin is in developing intended use and indication for use statements. The intended use will describe the general purpose of the device, or its function and include the indications for use. Indications for use describes the disease or condition that the device will diagnose, treat, prevent, cure, or mitigate including a description of the target patient population. In this example of a blood glucose test system or a glucometer, the product intends to give a quantitative measurement of the amount of glucose in fresh capillary whole blood. This product has been cleared by the FDA as safe and effective in diabetes treatment decision-making. If you're developing a medical device, these indications and intended use statements will help you to identify appropriate classification for your medical device product. They will possibly help identify a predicate device or a device that is already being marketed for sale that will support your FDA submission and identify possible testing and standards that you'll need to perform for the submission. The treat center has developed worksheets for forming these statements for your regulatory strategy. I've made them available within the module resources. Developing indications and intended use statements are important to your regulatory strategy, but also important in researching the product's ability to be paid for through healthcare reimbursement. Reimbursement by definition, is a sum paid to cover money that has been spent or lost. In healthcare, reimbursement is payment by a payer or insurer for health care services or products being delivered to a person. Reimbursement is often thought of as a three-legged stool, where coding, coverage, and payment support the seat. Seventy-five percent of the health care dollar spent in the United States come from public and private payers. Public payer programs are funded through US tax dollars. These payers include Medicare, which is a public health insurance program for individuals 65 and older, and Veterans Affairs healthcare for our veterans military population or Department of Defense. Tricare for the active military population is a public payer program. Medicaid is for individuals deemed medically needy or due to financial eligibility. Many assistive technology products tend to rely solely on Medicare or Medicaid payment, due to the types of patients they're trying to help. Fortunately, the publicly funded nature of these programs allows for more transparency than you may find in your research of coverage and payment by private payers. In contrast, private payers or private health insurance include plans that are either purchased from one of many private companies by an individual, but more often by an employer for employees. There are over 1,000 private payers for example, Cigna or Aetna covering 200 million Americans with various plans, even within single companies. I've included more resources in this module to help you perform a coding and coverage search relevant to your product. The US health care system as a testing ground for alternative payment models. Though these alternative payment models are increasing in popularity, fee for service as a payment model remains dominant in the United States. Services and products are itemized in fee-for-service and individual items are assigned to code. Coverage and payment for those items, are determined by the payer or insurer in negotiation with other health care stakeholders. Bundled care allows a player to provide a single payment for an episode of care. For example, a payer may set a price ceiling for a total knee replacement. Any service or product that the health care facility or provider uses exceeding that set payment would not be reimbursable. Value or Merit Based payment is a payment or increased incentive payments based on patient outcomes or quality measures. A good example of this is documentation of patient pain assessment and follow-up care. Consider and research what payment model best suits the product you are developing, particularly if coding and coverage does not currently support your product. Visit the module resources for more information on new technology payment opportunities. Medical coding is the nomenclature used to communicate between health care providers and suppliers, and payers. Though I won't be going into detail on the coding types, there is a link in the module resources for more information and how to perform a code search. The assistive technology or medical product you are creating likely fits into one of two categories. If the product is an item that will be used in a healthcare setting such as a physical therapy clinic, then it is likely that the product will be paid for as a procedural code. An example of this is a current procedural terminology or CPT code, where the physical therapist or skilled health care professional is paid not for the use of the product, but rather for the delivery of care and the time and skill level assigned to that code. In some cases, there may also be a code for the product. The second category to consider, is whether the product will be used at home. This would be referred to as durable medical equipment or prosthetics, orthotics, and supplies: often abbreviated as DMEPOS. DMEPOS may include things like wheelchairs, walkers and canes, or prosthetic limb, orthotic brace, even glucometers, test stripes or enteral feeding supplies. These types of products will be covered under the HCPCS Level 2 codes, and a link to a database to search for existing codes is included in the module resources. An important note when developing a reimbursement strategy for your product and communicating with your customers, is that you can't guarantee reimbursement for your customers. You can however, provide reimbursement education or resources that lessen the burden for new coding and new coverage negotiations with payers, such as a hotline or a page dedicated to reimbursement on your website. A regulatory and reimbursement strategy describes the approach that will be used to meet regulatory, and industrial standards and third-party payment for the product. For medical devices, this means a plan for achieving US FDA clearance, and determining who will pay for this product. Whether it can be reimbursed by public or private payers or whether it must be paid for out of pocket. It's also important for you to remember that these regulatory and payment policies and guidance documents are not set in stone. This is an ever-changing landscape that is important for you to monitor especially if your product development timeline spans multiple years. Additional resources for next steps in developing your specific strategy are available at treatcenter.org. I highly recommend that you create an account and access the educational materials found within the regulatory strategy module.