Detailed discussion on what to achieve

Design & Development

The second Sanner IDP Process® phase is device design. Concepting is further developed with more detailed CAD data, physical 3D models, material selection and regulatory assessments.   

Sanner Envelope

Sanner’s Design Center of Excellence, Springboard Pro, specializes in device design and development from the front end of innovation through to manufacture with a full suite of user insights, engineering, multidisciplinary science and forensic engineering, delivering a full-service offering.

All work is conducted according to “ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes and for complex devices such as pens or autoinjectors, testing is performed to the relevant ISO standard 11608.”

Springboard has extensive in-house capabilities for medical device development such as physics, engineering, electronics, software, and materials science. Over the years, Springboard has earned a strong reputation for fast and cost-effective regulated medical device development that delivers valuable intellectual property for customers.

Springboard’s expertise spans across drug delivery devices, such as autoinjectors, infusion pumps, inhalers and syringes, and equipment and consumables in the fields of diagnostics, respiratory, surgical, critical care, implantables, and biotechnology. With Springboard Pro, Sanner Group offers end-to-end development as Medical CDMO.

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Opportunity and research
 

Springboard can help you translate the business case into project requirements, and perform the research needed to find ways of meeting and exceeding those requirements.

The areas of research can include:

  • User research and Inclusive Medical Device Design to ensure user needs are understood properly.
  • Scientific research to build confidence in the fundamental scientific principles of operation.
  • Tech scouting and supplier research to ensure that existing technologies and supply chains are used where appropriate.

Springboard’s experience and multidisciplinary teams for device design and development can quickly provide clear insight into the heart of the toughest business and technical challenges, thanks to their collaborative way of working and advanced analytical techniques.

Sanner’s multidisciplinary teams for device design and development can quickly provide clear insights

Concept and feasibility

Springboard’s teams of industrial designers and engineers for medical device design can translate user and business needs into compelling medical devices and combination products. From the earliest stages of medical device design, we focus on creating robust yet innovative designs where the robustness minimizes issues later in development, and the innovation provides competitive advantage (and often new intellectual property for clients).

Most importantly we set-up a comprehensive risk assessment to determine potential challenges that the medical concept could pose in future development and manufacturing phases and try to eliminate them at the device concept phase.

 Springboard has teams of industrial designers and engineers for medical device design.

Science and forensic engineering

Springboard’s strengths in physics, materials science, chemistry, and bioengineering mean you can benefit from:

  1. Scientific understanding to remove the guesswork and risk from technical developments, and
  2. Solving the difficult problems in device design and development that others struggle with, and therefore reduce commercial risk and costs.

Springboard, as medical device development consultancy, has an excellent reputation for Forensic Engineering using a proven custom project management strategy to turn ill-defined technical conundrums into logical and manageable plans for resolution. Solutions are robust because they are derived from a holistic review (rather than “guess and test”) and are based on an understanding of the underlying science.

Springboard makes use of analytical and numerical multi-physics modelling to predict device performance and inform testing.

Engineering development

The mechanical, electronic, and software engineering staff work in conjunction with in-house industrial designer and human factors engineers to provide a team covering all required capabilities.

Springboard has industry-leading Computer Aided Engineering and simulation software for rapid product development.

In addition, a full suite of in-house prototyping and test laboratories mean that prototyping and testing can be conducted for all but the most specialist activities in medical device development. Springboard can handle various materials including drugs and hazardous chemicals subject to risk assessment.

Statistical software is used to plan, record and analyze test results. Calibrated equipment is traceable back to national standards.

Human factors and industrial design

Understanding the way the device is used in the real world is critical to its commercial success and regulatory approval.

In the medical device design process, Springboard conducts human factors studies to ensure users can use the devices safely and effectively. Users can include patients, carers, healthcare professionals, parents, teachers, and so on.

Formative human factors studies are used to inform the design, instructions for use, secondary packaging and any related services.

Springboard’s integrated medical device development services mean that summative human factors studies are more likely to gain regulatory approval.

Finally, industrial designers are used to optimize the design for usability, differentiation, brand language, and user preference. User experience and user interaction (UX/UI) experts create compelling user interfaces for physical and digital products and services.

Transfer to manufacture

As a full service medical CDMO, Springboard’s seamless collaboration with Sanner’s engineering and manufacturing team ensures that designs are accurately translated into drawings and specifications that can be used to manufacture the product consistently. We apply our extensive device manufacturing experience to ensure critical data, designs and development learnings are captured in our design transfer process.

Our Design for Manufacturing and Assembly (DfMA) approaches are targeted to minimize timelines and costs, for example using techniques such as mold-flow simulations, Sanner engineers analyze mold cavity filling and temperature conditions in the planned tooling for optimal manufacturing quality, this can avoid costly changes to the final tooling at later stages. Additionally, we optimize our tooling designs in digital formats, not only from a feasibility perspective, but also for manufacturing parameters such as cycle time.

Sanner’s manufacturing experts apply decades of experience in large scale manufacturing and their in-depth knowledge of a variety of different technologies, such as injection molding, injection blow molding or 2K injection-molding, to medical CDMO customer projects.