SGH

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.

SGH

• 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. 

Our ambition is to offer you the best device and one that is perfectly suited to your needs. From a simple packaging solution to the most complex electro-medical device, a dosing device for liquid or solid medicines (including dosing syringes, measuring spoons, IML measuring cups, pipettes for droppers and more), a one-by-one dispensing solution (to count and/or dose capsules, gel capsules, micro-tablets, etc.), a dedicated transport solution (e.g. for auto-injectors, vials and bandages), a care or drug administration solution (nasal aspirator, spacer device, pill dispenser, etc.) or any other plastic device (plunger stem, dental solution, obstetrical probe, etc.), we use exactly the same methodology. We offer all the resources and skills you need:
• Monitoring of Project Quality throughout the product development process
• Specialists in Marketing to study your project and its environment and develop a successful marketing strategy
R&D engineers and designers to examine and then translate your requirement into a functional device
• Bespoke development of special machines designed for the product and its assembly by our Methods & automation unit
• High-performance, efficient Industrialisation capabilities
SGH

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

The marketing department is a real asset even before the device is designed and is involved from the outset of
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.
SGH

SGH

RESEARCH & DEVELOPMENT

Our design process is user-centric. Our engineers, designers and ergonomics specialists are in permanent contact with our customers and develop innovative, functional concepts to ensure they are both simple and user-friendly.

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.
SGH

Methods & automation

Our industrialisation centre develops and refines special machinery and implements production resources: assembly and inspection machines, automated islands, marking machines, etc. It designs, develops and optimises the industrial facilities to respond precisely to requirements and ensure perfect adaptability to the product and its assembly.

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.

SGH
SGH

INDUSTRIALIZATION

Production capacity:


SGH
More than 1 billion
items produced each year
SGH
14,500 m²
of production facilities on 3 sites
SGH
3,000 m²
of ISO8 cleanrooms
SGH
2,100 m²
of finishing workshop
SGH
1 ESD protected
150 m²

electronic assembly workshop
SGH
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
We use our historical industrial know-how on modern sites, designed for lean manufacturing, providing high-speed production from small to very large production runs. We provide you with access to our controlled-environment production areas and cleanrooms, finishing workshops (printing, and assembly on fully automated lines) and electronic assembly workshop for full bespoke manufacturing or medical subcontracting. Every production run is under the permanent control of the quality team and our qualified personnel, who are trained in GMP on an ongoing basis.

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.

SGH