Stability, operational testing, safe transportation, packaging, and electrical safety tests are among the many services that qualified contract testing providers must be able to offer to medical device manufacturers, according to Glenn Kruschinski, test-lab director at Cincinnati Sub-Zero Products Inc. (Cincinnati).
MPMN: How can contract testing service providers help OEMs overcome their main manufacturing challenges?
Kruschinski: With increasing pressure from FDA and other regulatory bodies to comply with a host of specifications, medical device OEMs face a great deal of design validation, documentation, and product testing challenges. At the same time, they try to get new products to market faster and stay ahead of the competition. For example, all medical device equipment utilizing electronics is required to meet the IEC 60601-1 standard governing safety and performance testing requirements. All new products, and many product changes as well, must follow this standard. Thus, OEMs benefit from outsourcing their testing needs to a contract testing laboratory. Instead of investing in the various types of equipment that are required for performing testing procedures in-house, OEMs can contract out their testing needs to a lab that also provides third-party design verification and validation testing services.
MPMN: Which tests should OEMs expect contract testing service providers to perform?
Kruschinski: Test laboratories should be able to offer stability testing services and ICH Q1A guidance document testing, which involves long-term testing of products in simulated environments under different temperature extremes. Labs should also be able to accommodate International Safe Transit Association (ISTA) specifications for performing critical tests involving transportation, shipping conditions, and packaging. In addition, testing service providers should be able to comply with the ASTM 1980 standard regulating accelerated aging for simulated life testing, customer-specified analyses that often require operational testing, and electromagnetic compatibility compliance testing—a set of design-validation procedures that ensures the electrical safety of medical devices.
MPMN: To fully support medical device OEMs, which technologies and equipment should testing partners offer?
Kruschinski: From the environmental simulation standpoint, testing service partners should offer several types of environmental test chambers, including smaller reach-in chambers and large walk-in rooms suitable for performing batch/lot and package testing. Suppliers must also be able to equip such chambers with temperature and/or humidity, temperature and vibration, and temperature and altitude testing capabilities. In addition, vibration shakers that can accommodate a range of product sizes should be offered for performing reliability and transportation tests. Data-acquisition technology for documenting and reporting test results is also crucial.
Testing, consulting, and certification
A comprehensive transitional analysis program for compliance evaluation and testing based on the third edition of IEC/EN/UL 60601-1 and 60601-1-2 for product safety and electromagnetic compatibility is available from D.L.S. Electronic Systems Inc. Providing medical device manufacturers with testing, consulting, and certification services, the company offers detailed engineering support at all stages of the compliance process, from initial design through final formal compliance testing. The transitional analysis program includes a detailed review of testing previously performed to determine whether it shows compliance with the updated standard.
D.L.S. Electronic Systems Inc.
Because biomedical components used in such applications as orthopedics are subject to complex loading forces over long periods of time, their design must be supported by material data gathered under in vivo conditions, a function that can be performed by DatapointLabs. The data gathered by the company are calibrated into models ready for use in finite-element analysis for structural integrity and creep studies or in computer-aided engineering for such processability analyses as injection molding simulation. The service provider can measure mechanical and viscoelastic properties under conditions specified as relevant for the application. It tests the mechanical, rheological, and thermal properties of materials used in orthopedic implants, catheters, stents, pacemakers, and other applications.
Extractables and leachables characterization
EAG Life Sciences specializes in the evaluation of extractables and leachables in medical devices. Exceeding the requirements of ISO 10993 for biocompatibility testing, the company is equipped to characterize, identify, and quantify extractables and leachables in a variety of devices, including packaging components, implantable devices, and drug-delivery devices for orally inhaled nasal drug products and parenterals. It can identify chemicals released or migrating from product or packaging components made of rubber, plastic, or glass under various conditions of normal use.
EAG Life Sciences
MARYLAND HEIGHTS, MO
V&V testing services
A team of software quality assurance experts is available at Full Spectrum Software Inc. to provide verification and validation (V&V) services for third-party-developed medical device and life science software and informatics systems. Certified to ISO 13485 standards for the development of medical devices, the company is able to design and develop all aspects of V&V documentation in compliance with the client’s quality management system and appropriate standards. It can help expedite product validation, ensure product reliability, and streamline both automated and manual test protocols. Services cover a variety of platforms for medical imaging systems, child incubators, image-guided radiation therapy, patient-positioning systems, and other medical devices.
Full Spectrum Software Inc.
Contract testing services
Cincinnati Sub-Zero Testing Services provides accelerated-aging, stability, package, and reliability testing services for manufacturers of medical devices, medical packaging, medical test kits, respirators, inhalers, medical electronics, adhesives, and other products. The company subjects items under test to simulated environmental conditions involving temperature, humidity, altitude, corrosive assault, shock, and vibration. Customized testing can be performed for essentially any product at any point in the design cycle. The contractor’s service offering includes HALT and HASS testing for optimizing design or production processes and product reliability, along with tests that meet various ASTM specifications. Its facilities are equipped with more than 35 environmental chambers covering a temperature range of –99.4° to 374°F, six vibration tables, and two corrosion chambers.
Cincinnati Sub-Zero Testing Services