What Are the Major Steps Involved in the Manufacturing of a Medical Device? Part 1
What Are the Major Steps Involved in the Manufacturing of a Medical Device? Roberson Machine Company is a proven leader in medical device manufacturing. In addition to manufacturing devices with our unparalleled CNC machining services, to save time and money, we have the ability to take your idea from concept to prototyping to full production. And do so all under one roof.
The medical device manufacturing industry is a rapidly developing field, not only because of advances being made in our manufacturing processes but also because of continuous developments in the medical field. Roberson Machine Company has made a name for itself by constantly and consistently following best practices for designing and manufacturing medical devices. By using these best practices, we improve our performance by increasing quality and reducing waste, rework, and accidents. These practices include:
- Know Electronic Medical Device Reporting (eMDR)
- Follow quality system practices
- Utilize design controls for product development
The U.S. Food and Drug Administration (FDR) requires incidents involving a medical device, including certain malfunctions and incidents that resulted in serious injury or death, to be reported using eMDR.
We take our quality management standards seriously, rigorously checking our medical device manufacturing processes at every stage to guarantee consistent results. NQA is a global certification company that puts Quality Management Systems in place, with standards that must be met, before a company can begin servicing customers in our fields. We are ISO 9001- and AS9100-certified and are proud of our delegation.
Design controls are criteria required by the FDA to be met before moving the design toward final approval. They’re critical for medical device manufacturing due to the multi-step process required for certification and the guarantee that the device is on-track to meet our stringent regulations applicable to medical devices.
How Long Does It Take to Develop and Manufacture a Medical Device?
Developing and gaining approval for a new medical device can take 3 to 7 years to bring a device from concept to approval, according to studies, compared to an average of 12 years for drugs. This may seem like a long time, but it includes the entire device lifecycle.
Similar to drugs, medical devices go through a review process by the FDA before they can be marketed for use in patients. The governmental requirements are for all medical devices that are manufactured, repackaged, relabelled, or imported for sale. Under the requirements, a medical device is defined as any device used to diagnose, prevent, or treat a medical disease or condition without having any chemical action on any part of the body. The three classes of medical devices are:
- Class I devices are low-risk devices that are the quickest to gain FDA approval. Examples include bandages, handheld surgical instruments, and nonelectric wheelchairs. The majority of these can be self-registered with the FDA and can be approved in as little as one week.
- Class II devices are intermediate-risk devices. Approximately 43 percent of medical devices fall under this category and a manufacturer needs to prove device safety and efficacy through substantial comparison to another approved device. Examples include computed tomography (CT) scanners or infusion pumps for intravenous medications. The FDA will provide receipt of a submission for approval within 60 days, but the average time to receive clearance is 177 days, with just 19 percent being cleared within three months. Anaesthesiology devices have the longest average time to approval (245 days), while toxicology devices have the shortest (163 days).
- Class III devices are high-risk devices that are very important to health or sustaining life. They account for around 10 percent of products and include defibrillators, pacemakers, and deep-brain stimulators. The FDA requires adequate scientific evidence to show safety and efficacy of these products. The average time of approval is 243 days after submission.
What Are the Major Steps Involved in the Manufacturing of a Medical Device? | Roberson Machine Company
Whether you need contract manufacturing solutions, precision CNC machining services, or advanced insights into the world of medical device manufacturing, Roberson Machine Company is just a phone call, or click, away — call us at 573-646-3996 or contact us today.
Click here for Part 2 of this blog.