Medical device development
With experience co-developing devices with the top 25 pharma and biotech companies, we have strong expertise in product development and engineering.
Product development and engineering
Having worked with the world’s top 25 pharma and biotech companies to co-develop devices that have made a mark in the market, SHL Medical wields clear knowledge and experience in product development and engineering. Over the years, we have collaborated on new device concepts and platform-based offerings, as well as customer-owned technologies for bespoke projects. These successes have all been made possible by our insistence on science-based product development principles covering design input, testing, processes, and manufacturing engineering.
Our commitment to scientific and engineering best practices has enabled us to develop a systematic manufacturing process that consistently delivers products of highest possible quality. With more than two decades in the drug delivery industry, we have full mastery of the development process for device projects – encompassing early feasibility studies through to final assembly.
An overview of our development services
Design engineering
Our design engineering team manages pre-approval, device development, and post-approval lifecycle, ensuring seamless continuity from feasibility to production.
- Concurrent engineering
- Decades of iterative experience
- End-to-end from feasibility to manufacturing
Process development
With over two decades in drug delivery, we excel from feasibility studies to assembly. Our commitment to scientific best practices ensures a manufacturing process that delivers high-quality products.
- Vertical integration of processes
- Design for manufacturing and assembly
- Rigorous reviews by in-house experts
Testing and simulation
We prioritize users' needs in design and device performance. Our global team conducts comprehensive tests in dedicated labs, using in-house machines with interchangeable fixtures.
- Primary package characterization
- Custom testing machines
- Multiple in-house testing labs
Manufacturing
Our manufacturing science sets an industry standard. To support rapid growth, our manufacturing engineering department transforms production into advanced, cost-effective solutions.
- Excellence through continuous improvement
- Digital infrastructure for lean manufacturing
- Expertise in intralogistics and infrastructure
Support for container free testing
We support Container Free Release (CoFR) testing, enabling quality control without pre-filled syringes. This approach offers significant time and cost savings by eliminating syringe provision and shipping, while reducing supply chain risks.
- Time and cost savings
- Supply chain risk mitigation
Robustness studies
Container Closure Integrity Testing (CCIT)
At our Deerfield Beach site, we offer Container Closure Integrity Testing (CCIT) using the dye ingress test method. This service is available for a variety of devices, including syringes, cartridges, autoinjectors, and safety syringes. CCIT is a cost-effective alternative to sterility testing and helps ensure compliance with ISO 11608-3. By supporting multiple device configurations, we help our customers save both time and money.
Transportation studies
We offer transportation studies to support worldwide regulatory filings for combination products or fully assembled, labeled, and packaged products. Adhering to the FDA-recognized ASTM D4169 standard, we provide studies for autoinjectors and multiple configurations, saving time and money. Both simulated and real-world studies are available through an SHL-qualified external lab.
Curious to know more?
Covering the full drug delivery value chain, we provide peace of mind by offering end-to-end services.
Services
Learn more about the integrated services we offer.
Products
Learn more about our products
Partnerships
We are building a partnership network in various areas to enhance offerings for customers along the entire device value chain.