Company insight
Device validation gets a jump-start
Microspec says it is ‘setting standards’ with its JumpStart programme. Company founder and CEO Tim Steele explains what the programme is and how it can help device manufacturers get ahead of challenging and often time-consuming validation protocols.
T
he butterfly effect or not, the idea that even the smallest of issues can ultimately have substantial effects is not in doubt. In the medical device world, every element of a device is vulnerable to this. From its design and manufacture to ultimate use, small and often unintentional deviations can result in significant and sometimes dangerous consequences. That is why qualification and validation protocols are essential; the likes of installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). “IQ documents that equipment has been installed according to the manufacturer’s specifications, is properly connected to the required utilities and operates as designed,” explains Tim Steele, founder and CEO of Microspec, an ISO 13485 contract manufacturer specialising in custom medical tubing for medical device customers. “QQ typically represents worst-case process conditions and quality outcomes.”
expertise in extrusion within the industry, Microspec engages in strategic partnerships with the customer contributing design and material input,” he continues.
Navigate complexity
Qualification and validation processes are complex, requiring significant input from all parties. However, increasingly demanding timeframes are adding to the complexities, which is why Microspec has launched its JumpStart initiative. Steele says: “It is expected, within the development of the extrusion process, to negotiate with the customer print specifications and tolerances, and to align product specifications and design intent with manufacturability and capability requirements. These negotiations are critical to the process and ensure a robust and validated process is achieved.”
During the development of the part in early phases of the project, it is important
“Being able to deliver this support, and to react quickly and adjust within aggressive timelines is critical to a successful validation programme.”
The company, founded in 1989, ran its first extrusion in 1990; it continues to do so today, serving as an industry leader with a global reputation for innovation, quality and a willingness to accept challenges. “These are complex geometries and extrusions with multiple lumens, manufactured to customer-supplied designs and specifications, and used in a variety of innovative medical devices,” says Steele. Products include extruded custom bump tubing, co-extrusions, microextrusions, multilumen tubing, profile extrusions and coated wires. “In addition to a proven
to identify and mitigate factors that pose risks to the validation. Among them is understanding and minimising sources of variation in the process or due to measurement error, defining inspection methods, evaluating process performance with multiple lots of raw materials, and understanding product normalisation. “Microspec recognised the need and the opportunity to develop the JumpStart Validation Programme to improve the validation delivery timeline needed to meet and support the aggressive customer timelines, and requirements
Medical Device Developments /
www.nsmedicaldevices.com
for customer design validation (DV) builds and product launch,” Steele says. “We realised terrific gains by identifying early the intent to validate and thereby engaging the customer up front in the development of the extrusion process to leverage prototype extrusions and data, and align with validation and capability objectives and requirements.”
A new standard
The company says JumpStart is defined by discrete phases with targeted and customised activities and objectives, from prototyping and development through OQ/PQ that are intended to streamline the path to validation. The first phase, which takes between seven and 15 weeks, includes the initial feasibility extrusion, nominal process development extrusion and a quality review. Phase two runs for between five and 11 weeks and includes a tooling capability and process window study, quality review, and an internal and customer review. Finally, taking between four and eight weeks, phase three covers OQ and PQ validation.
Steele says JumpStart supports customers through validation processes and results in validated components that meet the requirements of the customer’s DV builds, master validation plan and submission, as well as their product launch. “Being able to deliver this support, and to react quickly and adjust within aggressive timelines is critical to a successful validation programme. Having the engineering expertise and technical capability to design and manufacture in-house allows Microspec to react quickly within aggressive timelines. We are setting a new standard in the industry,” Steele concludes. ●
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