Short answer: Before Q3 begins, medical device companies should verify five key compliance areas: FDA establishment registration, QMSR implementation, inspection readiness, U.S. Agent designation (for foreign manufacturers), and the status of any open FDA 483 corrective actions. Addressing these items now can help avoid compliance issues and last-minute challenges during the October registration renewal period.
In recent years, reimbursement by insurers has trumped FDA regulatory approval as the medical device industry’s biggest concern and remains at the forefront of stakeholders’ minds. To prevent reimbursement issues from impacting financing goals, device manufacturers must develop a well-planned reimbursement strategy in parallel with their regulatory and clinical strategies in the early phases of
These days, it often seems the main struggle for medical device companies is not earning FDA regulatory approval, but rather, securing reimbursement and payment from CMS and private payers. Here are some tips for you to consider. First, develop a reimbursement strategy early on in your product’s development by receiving recommendations from a consulting reimbursement
It is extremely important that those who work in a medical device company know the various players they must deal with to achieve success. A provider is a person or institution who directly provides medical, surgical or health services and who bills an insurance company for services rendered and is paid for them in the
What Medical Device Companies Need to Know The path to medical device commercialization in the U.S. is long and complex with many hurdles. The two most significant challenges are obtaining FDA approval and positive coverage decisions from payers. The most important players in these coverage decisions are Medicare and large commercial insurers, such as Aetna,
Given the complexities of reimbursement, what can a manufacturer do to influence the process and achieve the best possible result? First and foremost, it is never too soon to begin thinking about issues related to coverage and reimbursement. Many companies develop unique medical devices with the expectation that issues such as coding, coverage and payment
In the US, there are publicly funded payers such as Medicaid and Medicare, and privately funded payers such as managed care companies. In general, the extent and range of benefits provided are governed by law in public payer systems and by contracts between the private payers and the purchasers of health care (usually employers). Medicare
When you are asked: “Why should I use your medical device when the device I’m using now results in patient outcomes which seem to be adequate”, your answer should be a convincing value story (aka value proposition). A VALUE STORY is a clear and concise statement which demonstrates the clinical and economic benefits of using your
If you don’t plan where you are going, you’ll never get there. Once you have conducted a comprehensive reimbursement landscape assessment from the beginning and not before launch, it is critical to develop a reimbursement roadmap. This document is a visual, month-by-month plan for action for both the financial and operational aspects of the business
No matter how hard it is to manufacture a safe and efficacious medical device, it is not going to generate the anticipated revenues unless it can be properly reimbursed by insurers. While considerable time, effort and expense are required to successfully carry out a reimbursement strategy, such a plan is essential to assuring a favorable
mdi Consultants, Inc