We design & develop medical devices
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Salthaus is a medical product design & development consultancy specialising in minimally invasive, or keyhole surgical devices.
We are experienced in helping our Clients bring innovative solutions to market safely and efficiently. Our strength is our flexible, pragmatic and positive approach to product development and the way we embrace engineering challenges, working with our clients and collaborators to arrive at the optimum solution.
Design & development consultancy
We work with medical device SMEs that intend to release new products to the market or strengthen existing lines.
Collaborative R&D partnerships
We work with academic and commercial partners on early stage research and development projects.
"...the Salthaus new product development process provides a stage-gated road map for regulatory approved, fully resolved & commercially viable product solutions"
we believe learning from past experience is crucial to future success. For this reason we have developed our own comprehensive New Product Development procedure that has been specifically created to enhance cross-departmental communication and place an emphasis on good design practices.
"We believe product design & development should be a methodical process that leaves room for engineering creativity."
This is an approach that results in safe, well resolved products without stifling innovation or ignoring brand values.The stage-gated system provides structure for regulatory compliance and continued commercial focus.
The seed idea can come from a variety of places - maybe a solution to a problem recognised by a medical professional or a gap in the businesses product offering highlighted by the sales and marketing team? The proposal is summarised using the minimal resource, ready for presentation to the Project Review Board (PRB).
Stage 1 has determined the proposed project fits within the companies business model. Stage 2 see an increase in resource - reviewing key market data and regulatory pathways to establish commercial feasibility.
With commercial feasibility established a product development team can be assigned. The deliverable of stage 3 is a fully resolved concept proposal that satisfies that Design Inputs. This may include functional prototypes or photo realistic renderings depending on what is appropriate for the project.
4.0 product design
The Concept is defined - now the pre-tooling component development and advance supplier liaison can commence. Fundamental engineering process such as tolerance studies, BOM generation and engineering drawing creation are completed. Final Advanced prototypes reduce risk and build confidence prior to tooling commitment.
5.0 design, develop & detail
Tooling refinement and document preperation ahead of producing multiple off-tool, off-process production intent devices for V&V testing.
Device performance testing to prove the Design Inputs have been achieved.
Clinical evaluation to prove the Design Inputs were correct and the product is suitable for the market.
The transition from development to production.
Regulatory approval has been received and the product can be released to the market.
10.0 post market surveillance
The product is closely monitored following production release. to ensure any potential issues can be quickly identified and resolved.
The key to a successful project – it's all about the process...
Understanding the user requirements is fundamental to the medical device design industry – clear documentation and project structure is essential to record the decision making processes that ensure we fulfil those requirements.
Our comprehensive new product development process allows us to structure projects with a strong focus on good design practices whilst ensuring compliance with the stringent regulatory requirements that opitimise the medical device industry.
The stage gate format provides flexibility and means projects can be broken down depending on commercial requirements. If a project is funded for example, it may initially run only to the proof of concept stage before further funding can be released. The process allows projects to be hibernated with a completely updated design history file ready to be resurrected when funding becomes available.
Want to learn more about minimally invasive surgery?
At Salthaus we often work on highly sensitive projects where confidentiality is essential and we take our commitments very seriously. As a result we are limited on what project information we can share. Please find some typical examples of our work below...
Commercial design projects
Collaborative R&D partnerships
Salthaus is based in the beautiful county of West Yorkshire in the UK. Our design studio is part of a converted mill near the UNESCO world heritage village of Saltaire.
We would love the opportunity to discuss how we could add value to your next project.
20 mercury quays, ashley lane, shipley, west yorkshire BD17 7DB,