Mark Rauenzahn, Innova Engineered Plastics CEO: “With decades of experience managing highly engineered, multi-part projects, we support the full product development lifecycle—from concept and prototyping to manufacturing, assembly, and full-scale production.”

The Silicon Review

Innova Engineered Plastics, formerly ThermoFab, established in 1976, is a leading manufacturer of engineered heavy-gauge plastic enclosures and related components. Originally founded to manufacture early CAD and computer enclosures, the company quickly evolved to meet the growing demands of high-performance industries. By 1985, Innova expanded into its Shirley, Massachusetts facility, enabling advanced five-axis CNC machining and in-house painting, marking a significant step toward becoming a global supplier of precision plastic solutions.

Under CEO Mark Rauenzahn’s leadership, Innova has become a trusted partner to some of the world’s most innovative companies, with primary markets including Medical Device, Life Sciences, Aerospace & Defense, and Test & Measurement Instrumentation, and other critical highly regulated industries. Innova has expanded its capabilities to meet evolving needs in surgical robotics, organ transport devices, genetic sequencing devices, people scanning technologies, autonomous robots, information technology solutions and more.

Innova operates from its headquarters in Shirley, MA, and has an additional facility in Mexicali, Mexico, strategically positioned to serve a global customer base. Known for its commitment to durability, aesthetic excellence, and tight tolerances, Innova leverages decades of innovation and precision to continually push the limits of what engineered plastics can achieve in the most demanding environments.

In conversation with Mark Rauenzahn, CEO of Innova Engineered Plastics

Can you explain your services in brief?

Innova Engineered Plastics (formerly ThermoFab) is the leading provider of engineered heavy gauge plastic enclosures and related single use components for Medical Device, Life Sciences, Aerospace & Defense, Test & Measurement Instrumentation, and other critical highly regulated industries. We specialize in four core manufacturing processes: injection molding, reaction injection molding (RIM), thermoforming, and cast urethane. These expanded capabilities allow us to achieve intricate details and complex geometries, enhancing both the aesthetics and functionality of your product. We are the only company with all four technologies under one roof and help customers choose the best method for their application.

With decades of experience managing complex, multi-part projects, we support the full product development lifecycle—from concept and prototyping to manufacturing, assembly, and full-scale production. Our team collaborates with you at every stage to bring concepts to life.

We support parts up to 6ft x 8ft using a wide range of materials. Typical components include:

Medical device enclosures/housings
Robot enclosures/housing
User interface/display enclosures
Workstation enclosures
Battery enclosures
Camera enclosures
Electronic equipment enclosures

Innova specializes in heavy-gauge plastic enclosures for critical industries like medical devices and defense. Could you elaborate on the technical challenges involved in designing and manufacturing these components?

Designing and manufacturing heavy-gauge plastic enclosures for critical sectors like medical and defense brings technical challenges. These components require precise tolerances, exceptional durability, functional performance and compatibility with regulatory standards. Our team addresses these challenges by leveraging our expertise in plastic molding and advanced assembly, combined with early-stage design collaboration.

We work closely with customers to ensure material selections meet requirements for durability, chemical resistance, and performance. For example, surgical robotics enclosures must endure repeated sterilization while offering high impact resistance. Additionally, our ability to apply Design for Manufacturing and Assembly (DFMA) principles early in the product lifecycle help streamline development and optimize cost without compromising performance. Our vertically approach—from prototyping through production—enables Innova to solve complex challenges.

With the recent expansion into Mexicali, Mexico, how is Innova leveraging advanced manufacturing techniques to enhance production capabilities and meet growing demand?

With the launch of our new facility in Mexicali, Mexico, Innova Engineered Plastics is expanding not just in capacity but in capabilities as well. We are the only company in our industry that offers all four major molding processes—thermoforming, injection molding, reaction injection molding (RIM), and cast urethane—all under one roof. This allows us to tailor the optimal manufacturing method to each customer’s design, volume, and performance requirements.

This expanded footprint gives customers faster access to production, more capacity, and a broader range of solutions—all supported by advanced automation and expert engineering. Whether launching a new product or scaling an existing one, Innova has the right process to fit your needs.

Your company offers a comprehensive suite of services, from design and prototyping to full-scale production. How does this integrated approach add value for clients, particularly in terms of cost-effectiveness and time-to-market?

Early involvement in the product development process is a key differentiator that drives measurable value for our customers. By engaging with customers from the outset and applying our process design guidelines—including Design for Manufacturing and Assembly (DFMA), we help optimize designs for production, ensure parts meet regulatory requirements, and consistently meet quality standards. Over 80% of the products we manufacture, we supported some elements of the design.

Our fully integrated approach—from concept development and prototyping to production and enclosure assembly—streamlines communication, enhances quality control, and provides faster turnaround times.

Quality assurance is critical in regulated industries. How do Innova's ISO 9001:2015 and ISO 13485:2016 certifications reflect your commitment to quality, and what processes are in place to maintain these standards?

Innova recently achieved ISO 13485:2016 certification, which is for the medical device industry and builds on the principles of ISO 9001, which Innova is also certified in. ISO 13485:2016 is a comprehensive standard that helps medical device manufacturers establish a quality management system, ensuring the production of high-quality products that meet stringent regulatory requirements.

Our ISO 13485:2016 certification is harmonized with FDA expectations and includes the ISO 13485:2016+A11:2021 amendment, which integrates requirements of the European medical devices regulations and IVD medical devices regulation, which further aligns our processes with regulatory expectations.

Our comprehensive quality management system oversees all regulatory and quality requirements throughout the product lifecycle. This system includes proactive risk management to identify and mitigate potential issues, enhancing product safety and reliability. We have established control measures to ensure consistency and quality during manufacturing, regularly reviewing and refining processes for improvement. This commitment to continuous improvement helps us stay ahead in the industry and better serve our customers. We are now taking this one step further and going after an AS9100 certification to more fully be integrated with the aerospace industry.

What does the future hold for your company and its customers?

Looking to the future, Innova is exploring opportunities for growth through strategic acquisitions to expand our capabilities. By acquiring new companies, we aim to create synergies from a capacity and technology standpoint, delivering innovative solutions across every stage of the product lifecycle.

Meet the leader behind Innova Engineered Plastics

As CEO, Mark Rauenzahn has been instrumental in uniting the team around a shared vision of growth, innovation, and customer success. Under his leadership, Innova has expanded capabilities, added new facilities, and increased its presence in key markets. Mark’s strategic focus on team development and operational excellence has driven strategic investments in machinery, equipment, and processes—ensuring we deliver greater value to our customers while positioning the company for long-term success.