Design & Development
We partner with you to turn complex concepts into commercially viable life science instruments. Our teams integrate regulatory strategy, DfX optimization, and rigorous testing from day one, ensuring your product is compliant, reliable, and optimized for global scale, accelerating your path to market.
Receive your quote directly from the manufacturer.
Our Design & Development services cover the complete ideation and engineering journey for complex medical and diagnostic devices:
- Product Strategy: We help define the technical and commercial roadmap, ensuring the device architecture, regulatory strategy (e.g., FDA, MDR compliance), and budget align with market goals from the outset.
- Product Development: Our experts manage the full engineering development, delivering a production-ready design that focuses heavily on compliance, intellectual property protection, and uncompromising reliability.
- Design for Excellence (DfX): We embed manufacturability, testability, and serviceability into the design, which critically reduces costs and time-to-market when scaling up production.
- Test Engineering: We develop and integrate custom, robust testing strategies and equipment to guarantee the quality and performance required for sensitive life-saving devices.
Technology readiness levels: A framework to help accelerate life science instrument development
Critically evaluating the commercial readiness or maturity of technology for a life sciences product can be challenging. Plexus has found great value in using the Technology Readiness Levels (TRL) framework to help scope life science instrument development projects, build alignment, identify risks and bring clarity to life sciences project management.
Is your life science technology ready for manufacturing?
Product development is complex, and it’s crucial to consider key factors that can prevent manufacturing delays.
In this article, Plexus outlines how to build a successful product, develop a strategy for supply chains and implementation of manufacturing tests, and how the Plexus product development process can support you in the timely launch of life-changing products.
Four keys to accelerating your medical device development timeline
In this article, Plexus outlines four important factors to consider when you’re looking to accelerate your life science or medical device design and development efforts.
From improving medical device time to market, planning for variability, and choosing the right design and engineering partner, discover how working smarter can avoid product launch delays.
Molecular diagnostic instrument
Getting your new molecular diagnostic (MDx) product to market quickly matters not only to you and your shareholders, but to the physicians and patients who need it.
A new technology company approached Plexus with a high investment hurdle - to launch and distribute a new MDx instrument for rapid bacterial detection, identification and antimicrobial susceptibility testing. This case study showcases how Plexus was able to minimize design and development delays, increase collaboration and help bring a new IVD technology to market.
Three key considerations to ensure a reputation for life science innovation
Life science technology demands fast-paced innovation. In this article, Plexus outlines the keys to staying at the forefront of life science product innovation, including how the right partner can cement your place as a leader in life science innovation.
Smart engineering strategies to future proof your system development
Wednesday, February 18 at 16:00 GMT | 17:00 CET | 11:00 EST | 08:00 PST
Join us for an in-depth session exploring the essential framework that guides life sciences and MedTech products from early scientific concept to sustained, high-volume production. We unpack the critical differences between R&D/assay development and production-ready medical projects, showing how an engineering-led approach anticipates the complexities of regulatory demands, scalability challenges, and long-term data capture.
Learn where early, strategic collaboration creates a decisive competitive advantage, and how addressing the non-obvious challenges early can mean the difference between a promising breakthrough and a reliable, profitable commercial product.
Key learning objectives:
- Recognize and adapt to the fundamental differences between scientific discovery (assay development) and product development (regulatory requirements).
- Understand how early engineering collaboration ensures the instrument development (hardware/software) supports and accelerates potential changes in the assay and data analysis.
- Identify the critical, non-obvious manufacturing and supply chain focus areas that must be addressed early to guarantee a smooth, successful product launch.
- Learn how to leverage Plexus's full-cycle expertise to transform a scientific concept into a high-quality, scalable, and commercially viable product.
Who should attend?
This event is perfect for individuals working in:
- Product & strategy management
- R&D
- Engineering & technical
- Quality & regulatory
- Assay development
Certificate of attendance
If you attend the live webinar, you will automatically receive a certificate of attendance, including a learning outcomes summary, for continuing education purposes. If you view the on-demand webinar, you can request a certificate of attendance by emailing editor@selectscience.net.
