*Please note: while some cost estimates are provided by Pathway NPI’s experts in this article, the question “How much does it cost to launch a medical device?” can vary on a number of extenuating factors. Our expertise in the Design, Regulatory, and Manufacturing phases of medical device design means you’ll get the most efficient single-source solution available. Please contact us to set up a consultation and get started.
It’s no secret that launching a medical device is expensive. In fact, the cost to launch a medical device can range from hundreds of thousands to over $30 million. The cost of launching a new medical device depends on many factors, such as the complexity of the device, the size of the market, regulatory requirements, and more.
One way to get an idea of the cost to launch a medical device is to look at the cost of bringing a new drug to market. According to estimates from the Tufts Center for the Study of Drug Development, it costs approximately $2.6 billion to bring a new drug to market in the United States. This number represents a steep overall rise in drug development costs over the last decade or so. The cost was $802 million in 2003.
While the cost of launching a new medical device is not as high as the cost of bringing a new drug to market, it is still a significant investment. Below, we will break down some of the key cost components associated with launching a new medical device.
The Cost of Design and Engineering
The cost of designing and engineering a new medical device can vary widely depending on the complexity of the device. Simple devices that only require design and development work can cost as little as $50,000 to bring to market. More complex devices that require significant engineering work can cost millions of dollars to develop.
In addition to the cost of design and engineering, companies also need to factor in the cost of tooling and prototyping when budgeting for a new medical device. Tooling costs can range from a few thousand dollars for simple injection molded plastic parts to several hundred thousand dollars for more complex metal components. Prototyping costs can also add up quickly, especially if multiple iterations are required.
Pathway NPI offers budget-friendly rapid prototyping services that are ideal even for small start-ups in the healthcare, biotech, and therapeutics industries. Bring a new product to market quickly and efficiently.
The Cost of Regulatory Approval
The cost of regulatory approval for a new medical device can vary depending on the complexity of the device and the regulatory pathway chosen.
For example, a simple Class I device that does not require premarket notification may cost only $20,000 to $50,000 to get through FDA review. On the other hand, a more complex Class III device that goes through the Premarket Approval (PMA) process may cost millions of dollars and take several years to get FDA approval.
The cost of regulatory approval also varies depending on the country in which the device will be marketed. For example, it is generally more expensive to get approval for a new medical device in Europe than it is in the United States.
Pathway NPI offers comprehensive regulatory services to help companies navigate the complex and ever-changing world of medical device regulations. We can help you choose the right regulatory pathway for your device and ensure that your device meets all applicable requirements.
The Cost of Manufacturing
The cost of manufacturing a new medical device can vary depending on the complexity of the device, the number of units required, and the chosen manufacturing process. In general, however, the cost of manufacturing a new medical device can range from a few thousand dollars to several million dollars.
One way to reduce the cost of manufacturing is to partner with a contract manufacturer that specializes in medical devices. Contract manufacturers typically have experience with a wide variety of materials and manufacturing processes, which can help save time and money during development. In addition, contract manufacturers usually have established relationships with suppliers, which can lead to cost savings on components and materials.
Pathway NPI is a leading contract manufacturer in the medical device industry and has partnered with dozens of businesses here in Southern California. We invite you to get in touch and begin the process of bringing your device to life!