FDA approval of medical devices starts with design

FDA approval of medical devices starts with design

Designing and manufacturing a medical device incorporates many of the same methods and processes as designing and building a car, except for one big difference: the U.S. Food and Drug Administration (FDA). Something as simple as a basic wooden tongue depressor or as complex as a programmable pacemaker with microchip technology are both considered medical devices by the FDA, the government arm that regulates the design, manufacture, packaging, and safety of medical devices. Lab equipment, test kits, and radiation-emitting products such as ultrasound, x-ray, and laser machinery also fall under the FDA’s regulated medical devices.

The medical device industry encompasses a wide variety of products and technologies, from hand tools and implantable screws, to computer-controlled surgical machines and artificial organs. According to Forrester Research, the U.S. is the world’s largest medical device market, valued at $43 billion. The industry is expected to grow at a rate of 9 percent per year through 2004. The development of more innovative medical devices in areas such as orthopedic implants, cardiovascular treatment, and surgical equipment continues to increase.

To account for the diverse design, manufacturing, and control procedures used to make such devices, the FDA has compiled Current Good Manufacturing Practice (CGMP) requirements that help manufacturers comply with FDA regulations. These CGMP regulations ultimately protect patients and users of medical devices from purchasing ineffective or dangerous products.

So how far into the design and production of a medical device should a manufacturer go before worrying about FDA compliance? According to the FDA, they must think about compliance at the very beginning, before the product is even designed. The FDA’s Center for Devices and Radiological Health (CDRH) – responsible for the regulation of medical devices and ionizing and non-ionizing radiation– emitting electronic products – has issued CGMP requirements for design controls that guide manufacturers from the very first drawing they make of a new device.

Design controls are a set of procedures incorporated into the design and development process that cover the life of the medical device, from design to production, distribution, maintenance, and obsolescence of the device. The design controls apply to all changes to the device or the manufacturing process, including those that occur long after a device has been introduced to the market. They include everything from the initial design input and review, to verification and validation of the design, to design changes and a history file of those changes. Once the device is designed, the FDA has further regulations covering clinical evaluation, manufacturing, packaging, labeling, and post-market surveillance of the device.

Sound mind-boggling? The FDA, and some commercially available software packages, can help medical device manufacturers get started.

Reducing the Risk

While the FDA is the best place to go for exact information on compliance with their regulations, there are a number of commercially available software packages that can help medical device manufacturers streamline their processes, reporting, and quality procedures to ensure compliance with CGMP standards.

NetRegulus is a provider of product quality intelligence software and services for FDA-regulated medical product manufacturers. Based in Oakbrook Terrace, IL, NetRegulus offers their PQIntelligence(TM) software, an enterprise-wide, Web-enabled data management package that lets users track products and product-related information from initial bench testing all the way through to product phase-out. It automates, organizes, and manages clinical, regulatory, and product data. It also provides tools to track marketing trends, file on-time regulatory reports, handle postmarket surveillance, manage clinical and scientific studies, and manage quality audits, field actions, and recalls.

Pilgrim Software (Tampa, FL) offers the Quality & Manufacturing Integrated System (Q&MIS(R)) suite of software that helps manufacturers analyze their manufacturing process, recognize trends and measure quality, and meet FDA guidelines. Also an enterprise-wide application, the Web-based product allows users to integrate audits, calibration management, document control issues, supplier quality management, preventive maintenance operations, internal process controls, and training processes into one approach. These different functions also can work as standalone applications.

Other companies, such as EduNeer- ing, provide online compliance education and risk management solutions for FDA compliance. In 1999, EduNeer- ing entered into a Cooperative Research & Development Agreement (CRADA) with the FDA to jointly develop online training programs and courses, which will ensure that everyone in industry and government has access to the same tools and core knowledge, enhancing compliance efforts by regulated manufacturers.

Earlier this year, Able Software received clearance from the FDA to market its 3D-DOCTOR software for medical imaging applications. 3D-DOCTOR is also a rendering and measurement software for computer tomography (CT), magnetic resonance imaging (MRI), microscopy, and other volumetric images. It creates 3D surface models from cross-section images in real time on a standard PC, letting doctors perform 3D visualizations of CT/MRI images. In effect, the software creates CAD models from medical images.

The software currently is in use by leading medical research organizations, and according to the company, the FDA clearance should help 3D-DOCTOR become more widely and rapidly adopted in other applications, including prototyping of medical devices.

Visit umasatech.com/features for more information on medical device manufacturing.

NASA/industry Partnership Improves Medical Device

NASA has consistently been in the forefront of innovative medical device development. The pacemaker, ingestible thermometer, microencapsulated drugs, cool vests, laser angio- plasty, and magnetic resonance imaging (MRI) systems all trace their roots to NASA-developed technologies. The technology behind a surgical tool that uses artificial intelligence to increase the safety, accuracy, and efficiency of delicate surgical operations has been licensed by NASA to a commercial company for development of an early breast cancer diagnostic device.

Originally developed by Dr. Robert Mah of NASA’s Ames Research Center in California, the “Smart Surgical Probe” was licensed to BioLuminate of Dublin, CA, which plans to develop, produce, and market a measurement device for early breast cancer detection. The device will consist of a disposable needle that will be used for each patient test. The needle will be used only after initial screening steps indicate the presence of a suspicious lesion.

The device provides six specific measurements of known cancer indicators, including oxygen partial pressure, electrical impedance, temperature, deoxygenated hemoglobin, vascularization, and tissue density.The measurements are taken simultaneously in real time as a small 20 to 21 gauge disposable needle, connected to a computer, is inserted into the lesion.The needle is expected to exceed the accuracy achieved by core needle biopsies, and should approach the accuracy of surgical biopsies.

Since results are provided in real time, doctors and patients don’t need to wait for pathology results, which could take up to two months from the first exam to the final diagnosis. If the resuits indicate the presence of cancer, treatments can begin immediately.

The average cost of breast cancer biopsies is approximately $2,620 per patient. The BioLuminate procedure is estimated to cost $525 per test, which includes a $250 disposable needle. The test system itself is expected to cost less than $50,000, and will include an electronic box about the size of a small typewriter that contains a computer, optical components, conversion electronics, and a display.

The combination of the NASA-developed probe technology, with BioLuminate’s approach to reduce the size of the probe to a small needle, makes this partnership a unique one in the medical device industry.

For more information, visit BioLuminate at www.bioluminate.com.

Copyright Associated Business Publications Oct 2001

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