Expertise

Injector pen device design and engineering

With more than 20 years of developing industry-leading drug delivery devices, Shaily pridesitself on being at the forefront of engineering excellence. Our commitment to innovation and quality enables us to consistently push boundaries and set new standards in the field, ensuring our devices meet the needs of both healthcare professionals and patients worldwide.

At Shaily Innovations, we've crafted a holistic approach for developing our advanced drug delivery devices. When taking an idea from concept to commercialisation, our streamlined approach ensures efficiency and great quality design.

Our Approach

Patient-led

Our key goal lies in addressing patient and healthcare worker needs, designing products that enhance and enrich the lives of those we serve. It’s important that each device we craft not only meets industry standards but also resonates with the individuals who rely on them, ensuring ease of use, simplicity and reliability.

Drug-led

When designing Combination Products, it’s crucial for us to consider the chemical qualities of the drug as well as its functional mechanism. With every drug comes its own distinct set of characteristics which we meticulously research and design for. From drug viscosity to sterilization methods, dose volumes, needle sizes, projected shelf life, number of doses, and temperatures - each element demands careful consideration and rigorous testing.

Precision Engineering

When designing drug delivery devices, it’s critical to follow a rigorous engineering process – ensuring optimal functionality, reliability, and dose accuracy. At Shaily Innovations, we take pride in our expert engineering capabilities and our ability to think creatively while tackling big design challenges.

Our Engineering process involves:

  • Design for manufacture and assembly
  • Material and process selection
  • Statistically driven tolerance stack analysis
  • Cost reduction / value engineering
  • CAD Design
  • Engineering calculation and simulation
  • Mechanisms and systems
  • Testing and experimentation

Discovering Intellectual Property

When developing our platforms, we consistently seek ways to enhance their design, aiming to improve user-experience, reduce costs, ensure greater reliability and ultimately create a superior product. In addition to making a better product, this approach is designed to find new Intellectual Property for our clients – a crucial part of our innovation strategy.  

During this process, we can support with:

  • Patent landscaping and identifying competitor patents
  • Supporting patent applications
  • Generating patent drawings
  • Patent analysis and defence writing
  • Creating functional description documentation to greatly assist the patent writing and searching processes.

Verification and Regulatory Support

At Shaily Innovations., we excel in supporting verification to 11608:2022 standards. Through Shaily Innovations, we assist in defining test criteria, outlining necessary tests based on product requirements, and developing testing protocols.

We also help with jig design, machine procurement, and analyse test data from verification studies. Our expertise includes validating test methods and swiftly addressing issues through root cause analysis, ensuring compliance and successful verification outcomes.

Design History File and Risk Management File Preparation

At Shaily Innovations, our verification and regulatory support encompass a comprehensive array of services tailored to meet stringent standards and compliance requirements.

We excel in preparing combination product design history files, including drug components, and meticulously generated FDA-approved design history files. Our team has expertise in assisting in client documentation, ensuring meticulousness and adherence to regulations.

The risk analysis approach and documents produced align with ISO-14971 guidelines. This involves failure modes and effects analysis (FMEA), which leads to thorough benefit/risk analysis and the final outcome being a summary detailing acceptable risk levels for the product. Our ISO-13485 quality management certification underscores our commitment to maintaining exceptional quality standards and enforcing stringent document controls. For streamlined processes, we utilise Greenlight Guru for new platform development, enhancing efficiency in creating Design History Files (DHF) and Risk Management Files (RMF).