Bespoke development & subcontracting
SGH Healthcaring creates and manufactures devices and takes charge of the industrialisation of bespoke plastics solutions for the medical market, primarily in the areas of drug administration, respiratory conditions, pre-analytics and e-health. Our experience and know-how have helped us broaden our skills into bespoke development to respond to all your requests, including the most demanding.
• Bespoke development:
We take care of the overall design of the product, based on its specification or a simple statement of your requirements, from intellectual property and identifying prior art right through to delivery of the final packaged product, ready to go on sale. Our development methods are governed by a strict, rigorous quality monitoring process, based on the four qualifying stages: design, installation, operations and performance.• Subcontracting:
We offer you access to modern, well-designed lean manufacturing facilities, providing high-speed production from small to very large runs along with our cleanrooms, printing and assembly workshops, including assembly of electronic devices. Every production run is under the permanent control of the quality team.
Project quality
Managing the quality system involves controlling every stage of the process, from identifying the customer’s requirements to shipping, including development, process characterisation and manufacturing, including for bespoke developments.
That’s why the QSE management system ensures compliance with the standards and regulations in effect for medical devices and primary packaging throughout the product life cycle, in every part of the business
(ISO 13485 and ISO 15378 certifications, in addition to ISO 14001 and ISO 50001).
Every project is unique. When developing a bespoke device, the regulatory constraints and quality tools used vary from one project to another. It takes a special level of attention to detail to evaluate and apply them.
A development quality manager is therefore entirely dedicated to supporting your project,
from the initial idea to delivery of the finished product, in close collaboration with the project manager.
By managing the development of your product end-to-end, we can provide you with a turnkey device, accompanied by the technical regulatory documentation for CE marking. In effect, we draft all your technical documentation ready for registration and keep it up to date in line with regulatory amendments
and/or changes to the device.
Entrust your project to us with complete peace of mind and let us take care of everything.
Marketing
A marketing approach that puts the user at the heart of development
a project, supporting it at every stage through to launch, analysing users’ needs and competing products.
It anticipates user requirements, identifies functionalities and even products that do not yet exist on the market or need to be improved, thus meeting customers’ future demands Working closely with the R&D department, marketing provides a methodology in several key stages to support the design of your future best-seller: 1. Gather information on markets, trends, competing products and more
2. Analyses user datas, needs and missing functionnalities
3. Produces thes product specification
4. Monitors development proposals with R&D, tracks tests on the functional protocols selected by the customer and challenges the improvements to be made
5. Develops marketing materials (packaging, display stand, communications campaign, etc.) for sales and marketing.
RESEARCH & DEVELOPMENT
Our R&D team both listens and is a proactive source of ideas, with responsibility for translating your needs and requirements into a functional product. Once the specifications have been drawn up, the project will come to life in a series of phases: feasibility checking, patentability, 3D plans, non-functional models (for example, for touch and volume) and then a functional prototype (factory produced or prototype).
From studying the requirement to managing intellectual property, the R&D department provides expertise and creativity at every stage of developing the project:
• Methodology and regulatory analysis: functional analyses, life cycles, risks and uses
• Creation: trend monitoring, ergonomics studies and proposed concepts
• Development: industrialisation of concepts
• Prototyping: rapid prototyping solution (FDM)
• Intellectual property: model registration, drafting of patents and trade marks
All our projects are run by a project manager, surrounded by a multidisciplinary team: marketing, development & design, industrial methodology, trials, development quality, regulatory affairs, logistics and sales and marketing. A four-stage process, with well-established milestones, is deployed to guarantee the success of all our projects.
Methods & automation
This in-house expertise allows us to manufacture bespoke items and identify the tools needed for our development, by managing costs and technical solutions: screwing technology, marking, visual control and packaging.
By producing our machines ourselves, we have better control of after-sales service. Any changes can be made quickly, at minimal cost.
INDUSTRIALIZATION
Production capacity:
More than 1 billion
items produced each year
14,500 m²
of production facilities on 3 sites
3,000 m²
of ISO8 cleanrooms
2,100 m²
of finishing workshop
1 ESD protected
150 m²
electronic assembly workshop
72
fully automated injection,
injection-blowing and extrusion-blowing moulding presses
Finishing:
• 18 fully automated assembly lines
• IML decoration with camera inspection
• Pad-printed marking or silkscreen printing with camera inspection
• Serialisation
• Individual wrapping and finishing of packaging
• Delivery to over 40 countries worldwide
Continuous improvement applies to our skills as well as our facilities.
As a result, we are particularly demanding on the status of our fully automated machinery, in order to maintain a high level of quality and performance.
Preventive and corrective maintenance is carried out on moulds and injection presses every day.
