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Medical Devices Quality Control – 3 Things to Consider When Selecting Equipment

By | Uncategorized, Articles

Ensuring that components used in medical devices are fit for purpose and comply with strict industry regulations means quality control is a critical step in the manufacturing process.  To deliver a high standard of quality control the correct equipment must be used to make these checks. This not only safeguards operator accuracy, but also allows quick, efficient checking.

In this article we look at the key points to consider when selecting equipment.

Equipment Practicality

The first thing to consider when selecting equipment for microscopic quality control is the type of work that the operator will be required to undertake.  As a starting point you need to consider if you will need to undertake non-contact measurements or whether you will be looking for surface defects.

When undertaking non-contact measurement the ability to use a digital overlay is extremely helpful when working with complex precision moulded pieces or irregular shapes.  In this instance it is simple and quick to place the component under the microscope and view the image of the component on a digital screen. You can then import a CAD drawing and use this as a digital overlay to ascertain whether the component fits within tolerance parameters. This process is ideal when working with medical implants.

Simpler more geometric shapes, such as diameters, distances, angles etc. can easily be measured using measurement software, providing that there is enough contrast under the microscope for the edges to be digitally detected.

Medical Device Components

In some cases, such as when the part is made of clear or white plastic, digital edge detection will be problematic. In this instance the higher resolution of an optical view may be required. An example of this would be when measuring the internal and external dimensions of tubing used in IV sets or the diameter of syringes.

In some situations there may be a need to conduct both non-contact measurement and surface checks. In such a situation a dual digital and optical microscope is the ideal choice. A case in point is quality control checks on stents.  There is a requirement to measure strut thickness and radii down to µm level, together with the overall stent dimensions. The stent then needs to be inspected for burrs and the overall quality of the surface finish.

Finally, practicality considerations are not only about functionality. With space being at a premium in any manufacturing area, equipment must be of a reasonable size, fitting on an average sized work bench.

Regulatory Compliance

In an industry where the failure of a device can have life-threatening consequences, a documentation procedure detailing evidence that all components are within tolerance levels is essential. However, the process should be streamlined to avoid delay in delivery time scales. Capturing of digital images for insertion into quality control documentation, together with the ability to mark-up measurements on these images is a definite advantage in this process.

And if for any reason there is a non-compliance issue, the marked-up image can quickly be shared with the production manager or supplier and the issue easily communicated for a quick resolution.

Of course, it goes without saying that any measuring equipment used should be calibrated to a relevant industry standard.

Operator Comfort

Last, but certainly not least, is the requirement for operator comfort.  An ergonomically designed system will allow operators to work for longer periods of time without experiencing eyestrain or posture related discomfort. Optimal ergonomics will ensure excellent levels of productivity and accuracy, not to mention happy staff!

The Swift PRO Duo, with its digital measurement system and optical eyepiece-less technology is the perfect solution for the quality control of medical device components.  Find out more about Swift PRO.

DRV-Z1 digital stereo 3D viewer with zoom

DRV-Z1 Launch Tour (US & MX) – World’s First 3D Stereo Digital Viewer

By | News

Vision Engineering are hosting one-day open house events for customers and media in across 5 locations in USA and Mexico to see the DRV-Z1 – the world’s first 3D stereo digital viewer with zoom.

  • DRV-Z1 brand new digital 3D display technologyWorcester, MA – June 11th
  • Orlando, FL – June 13th
  • Lisle,  IL – June 18th
  • Fremont, CA – June 20th
  • Tijuana, MX – June 25th

The DRV-Z1 is a first-of-its-kind technology that enables operators to view ultra-high definition 3D images, without wearing special glasses, or a VR headset. This is a true leapfrog technology for the manufacturing, design, engineering and research & development arenas.

Unlike most new technologies,  in this instance, seeing is literally believing. That’s because unlike every traditional industrial digital microscope before it, the DRV-Z1 has no screen: the 3D image ‘floats’ in front of a mirror in striking clarity. It’s technology so advanced it can’t be photographed or reproduced anywhere else.

The Vision Engineering team will be on hand to explain the core technology, answer questions and discuss the many ways potential applications for this new technology across a range of industrial and design applications, including:

  • Enabling real-time global collaboration by allowing users to to view and manipulate the same image in real time from interconnected DRV-Z1 viewers.
  • Advancing the quality control process by providing operators with unparalleled 3D visual acuity and flexibility, in an easy to operate, ergonomically optimized system.
  • Allowing anyone who models in 3D – mechanical engineers, graphic artists, component designers – to do so in a fully rendered, real-time environment with unprecedented image clarity.

To reserve your place at the DRV-Z1 launch Register here.

Space is limited so please register early to secure your place.

DRV-Z1 showing the benefits of ergomics to operator

Look after your staff and it will pay dividends

By | Articles

The path to success in the current business environment means competition and investment. Competing to get the best customers, the best suppliers and critically the best staff. The importance of securing and retaining the best staff can be vital. Staff often represent the largest ongoing investment on a company’s balance sheet and are often the only asset that can choose to walk out of the door.

So, how to get the most out of the staff without risking driving them away? The answer, ‘Look after them’.

DRV-Z1 showing the benefits of ergomics to operator

In the world of industrial inspection this starts with ergonomics. Studies show that staff who work regularly with magnification systems, like traditional microscopes, suffer neck pain, eye strain, headaches and back pain. They also are more prone to eye infection and musculoskeletal disorders and have increased levels of absenteeism.

Benefits for industrial inspection

Studies also show that ergonomic systems can help;

  • Improve operator productivity
  • Improve operator yield
  • Improve product quality
  • Reduce operator absenteeism
  • Reduce operator fatigue
  • Reduce risk factors for musculoskeletal disorders

With the cost of employing and training staff being high it makes sense to protect that investment. DRV-Z1 ergonomics will not only increase productivity and quality but help reduce the unnecessary costs of employing and training new staff.

Find out more about DRV-Z1 digital stereo 3D viewer with zoom.

Operator carrying out inspection with the ergonomic DRV-Z1

Studies are from a variety of sources including:
Thompson SK, Mason E, Dukes S. Ergonomics and cytotechnologists: reported musculoskeletal discomfort. Diagn Cytopathol. 2003;29:364–367.
Garima Jain and Pushparaja Shetty Occupational concerns associated with regular use of microscope: International Journal of occupational Medicine and Environmental Health 2014;27(4):591–598
Fritzsche et al.; licensee BioMed Central Ltd. 2012

EVO Cam II now does even more!

By | News

Vision Engineering is giving more to new and existing customers with the launch of their new firmware for EVO Cam II.

Backwards compatible with all existing EVO Cam II units, the new firmware extends the capability of the systems with a host of new features.

Features such as ‘Calibration tracking with zoom’ which automatically adjusts measurement calibrations with changes of zoom position; and ‘Image comparison’ that allows quick and easy comparison between a live and reference image are now available to all existing EVO Cam II users without extra charge.

Other features, include ‘Supervisor settings lock’, ‘Customisable zoom range’ and ‘Image playback’ as well as many more. EVO Cam II new firmware also allows access to unlock the premium (paid option) focus stacking feature*.

New customers also benefit from the firmware up date as the new features are added to EVO Cam II with no increase in RRP over the previous version.

Find out more about EVO Cam II

Launch of LVC400 fully automated 3-axis system

By | News

First fully automated 3-axis video measurement system from Vision Engineering

Today at Control, Stuttgart, sees the launch of LVC400, the first fully automated 3-axis video measurement system from Vision Engineering.

Ideal for measuring large components or multiple small components, quickly, easily and accurately, LVC400 offers faster measurement, high accuracy levels, and benefits from Vision Engineering’s consistent focus on ease of use for all its products.

Offering a larger (400 x 300mm) stage than comparably priced products, LVC400 offers large measuring capacity and fully automated movement in all 3 axes, making component measurement faster. Non-stop measurement routines are possible through programmes which can have magnification changes built in.

Additionally, multiple components can be loaded onto the stage and measured easily and automatically in a single programme. The system is pre-programmable or can be driven using the supplied joystick for rapid, one off measurements.

Highly accurate

LVC400 features a high resolution 5MP USB3 camera, granite base for extra stability and a precision X-Y stage; making it the most accurate large format measuring system from Vision Engineering to date. LVC400 also supports the use of a touch probe in all 3 axes, for measuring complex features and other 3D forms.

Easy to use

LVC400 is supplied with the highly intuitive M3 software package; offering comprehensive measurement functions, whilst maintaining the ease of use that Vision Engineering is well known for. M3 software includes full reporting and data export, DXF overlays and fitting, and thread measurement.

Vision Engineering anticipates that LVC400 will be used when customers require the measurement of large components, in applications such as precision machining, casting, plastic mouldings, electronics, and PCB inspection.

Additionally LVC400 is ideal when customer requires measurement automation, including palletising of smaller components, faster automated measurement of large components and automated measurement of components that require change of magnification.

Paul Newbatt, Vision Engineering’s Sales and Marketing Director said:

Launching LVC400, our first fully automated 3-axis video measurement system, marks the latest in the extension of our range of Metrology products. We anticipate that a wide base of customers will find the LVC400’s large stage, accuracy, ease of use, combined with a competitive price point a very attractive proposition.”

Highlights:

  • LVC400 is for applications that require higher accuracy and/or contact measurement
  • Supplied with M3 software for ease of use and intuitive operation
  • Ideal for customers who want to measure large components or multiple small components quickly and easily
  • Competitively priced
  • LVC400 designed for measurement application in:
    • Precision machining, casting
    • Plastic mouldings
    • Electronics, PCB inspection
  • Customer requires automated workflow:
    • Automatic measurement of palletised component arrays
    • Faster, automated measurement of large components
    • Automated measurement of components at multiple magnifications

Contact your local Vision Engineering office to arrange a demonstration.

DRV-Z1 digital stereo 3D viewer with zoom

DRV-Z1 ‘Game Changing’ 3D digital display technology launched at Control

By | News

Today we are excited to unveil a revolutionary digital 3D stereoscopic display technology at Control, Stuttgart. Unlike traditional mono digital microscopes, Vision Engineering’s Deep Reality Viewer (DRV) creates stereo high definition 3D images, without using a monitor or requiring operators to wear headsets or specialist glasses: images ‘float’ in front of a mirror.

Using Vision Engineering’s patented TriTeQ3 digital 3D display technology, the DRV-Z1 (Zoom model 1) incorporates a microscope and is the first device of its class to be launched by the manufacturer.

Developed to address quality control and assurance requirements in sectors including electronics, aerospace, automotive and medical industries, DRV-Z1 is designed to advance the quality control and production process, by enabling operators to view magnified subjects in 3D, in unprecedented detail, without the need for additional viewing apparatus.

The award-winning manufacturer also sees huge capability for improving the quality control process in a broad range of industries. For example, in Life Science applications, it enables biological samples to be examined in stereoscopic HD 3D, without risking heat damage to tissues.

Commenting on the technological breakthrough, Paul Newbatt, Vision Engineering’s Sales and Marketing Director said:

TriTeQ3 blends Vision Engineering’s long-established, industry-proven and award-winning optical stereoscopic technologies and digital monoscopic technologies. DRV-Z1 delivers a technological breakthrough, and is a game changer for inspection and quality control processes.”

Mark Curtis, managing director of Vision Engineering said:

Over the past 60 years Vision Engineering has built its reputation on the innovation, quality, performance and ergonomics of our visual inspection and metrology systems. DRV-Z1 provides enhanced 3D visualisation and overcomes current problems with 3D modelling and inspection systems. By amalgamating our existing technologies, we’ve delivered an entirely new concept to our existing customer base, as well as opening up opportunities in fresh markets.”

Highlights

  • Unique deep reality viewer enables stereoscopic 3D viewing with vivid depth perception, at UHD resolution, without requiring special eye wear or VR headsets
  • Developed to address QC and QA requirements in electronics, automotive engineering, aerospace industries and all precision engineering applications
  • Break-through technology from the inventors of the award-winning ergonomic Mantis microscopes: the original and best
  • First of its class
  • An amalgamation of Vision Engineering’s award-winning optical stereoscopic and digital monoscopic technologies
  • Ergonomic design reduces operator fatigue and promotes productivity and accuracy
  • Enables remote viewing of dynamic 3D images in in stereo full HD
  • Enables improved accuracy in manufacturing processes such as deburring and reworking
  • DRV-Z1 is the first in a series of innovative 3D stereo full HD resolution viewing systems, based on Vision Engineering’s patented TriTeQ3 technology

Find out more

Dental technicians laboratory London

Dental Technicians Raise the Quality of Dental Restoration and Operator Comfort

By | Case Studies

Anthony Laurie of DentAL Excellence Ltd operates a technical dental laboratory in the heart of London and bases his business around the delivery of exceptional dental restorations to his demanding customer base. Tony introduced advanced Vision Engineering Mantis magnification for all of his technicians. The need for this level of magnification equipment is explored.

Dental marketplace

Many famous people make use of dental restoration to enhance their appearance and while this type of treatment was only available to a limited group of people it is becoming more widely used. Dental restorations include clinical need as well as aesthetic need, with restorations used in the treatment of accidents and illness.

The process for the creation of dental restorations has developed in recent years due to pressure in the dental market place and the introduction of technically superior material products and manufacturing technology.

Fig 1 Dental Excellence
London Laboratory

New materials have forced the dental industry worldwide to re-examine the application of materials to the art of dental restoration. What is seen in the photographs and smile today was in the mind and hands of the dental technician yesterday. It is the technician who determines the quality of the restoration that in turn defines the smile, the bite and the chew.

Initially, the patient has a consultation where the dentist provides a prescription for reconstruction to restore ideal jaw function or to improve aesthetics.

Dental restoration manufacturing process

The process of manufacturing dental restoration begins with the preparation of the existing teeth or providing implants in the mouth. When prepared, the dentist takes an impression of the teeth and surrounding tissues.

The patient is fitted with temporary restorations to protect the prepared areas and impressions are taken, to be sent to the dental laboratory, together with any other relevant information on the patient’s clinical situation.

Even at this early stage, it is vital that the impressions are free of defects. From the impressions, stone models are made of the upper and lower jaws which are then articulated together to represent the patient’s bite.

Fig 2 Checking Marginal
Fit of Wax Model

The stone model of interest is sectioned at the location of the restoration and the prepared areas are removed and trimmed. The artistry of the technician now comes to the fore as he makes a wax version of the restoration.

The wax is used to cast the frame of the restoration and the frame will carry the porcelain surfaces and connect to the carrying teeth or detail implants. When the technician, the dentist and patient are happy, the crown or bridge is permanently cemented or bonded in place.

Some dental technicians and dentists are willing to accept poor quality for restoration and these can be can be delivered and fitted. It is obvious where the poor fit of the crowns has caused the gums to recede, exposing dark margins and collecting decay.

Fig 3 Poorly fitting crown

The Clinical failure of these restorations may only come to light many months after the fitting, and only be seen by the dentist.

The implications of a poor clinical fit are poor dental hygiene and dental work being required soon after the fitting. The poor manufacture and fitting of dental restorations can cause medical issues and do not look good on the patient.

For this reason the quality of the restoration should be checked at every stage of manufacture to assure that the manufacturing will provide a high quality restoration and a high quality of clinical fit assuring long service life and excellent aesthetics.

Tony Laurie describes his philosophy:

”In all cases my technicians make use of magnification to check the build and fit of our restorations.

“We check at each stage of the process and it is this attention to detail and the high quality magnified images from our Mantis systems which allow us to detect any minor issues and to correct them at the earliest opportunity.

“We make sure that at each step of the process we have made the best restoration and we have the correct fit.”

Rejection is a costly error

Fig 4 Poorly Fitting 30 year
old Crowns

A restoration does have a manufacturing problem then there may be a cumulative effect as at each stage of the process the errors can be amplified. Adding value to a restoration which may be clinically inferior at best or rejected at worst is a costly error for the business.

Figure 4 shows four anterior porcelain jacket crowns, three of which were 30 years old. It is obvious where the poor fit of the crowns has caused the gums to recede, exposing dark margins & collecting decay.

Fig 5 New Restorations

Figure 5 shows the same patient with newly fitted crowns. The gums look extremely healthy and the aesthetic result is excellent.

Tony Laurie puts it succinctly:

“With each technician checking the work at each stage of the process we have both a high quality product in technology terms and a high quality product in aesthetic terms. The use of Mantis® is an enabling technology and keeps all of my technicians happy.

“They know the difference between good and poor quality and by using Mantis they can see the difference.”

DentAL Excellence Company background

DentAL Excellence is high quality specialist restorative and implant technology laboratory together with a state of the art training facility and was founded by Anthony Laurie to design, produce dental restorations using the latest CAD-CAM, laser, induction casting and digital technologies. DentAL Excellence also provides a high level of training for the industry.

Vision Optics - custom optical components

New Vision Optics website launched

By | Uncategorized, News

Vision Optics is a new division of Vision Engineering Ltd that specialises in supplying high quality optical components: lenses, mirrors, prisms and filters, as well as optical design services, custom optics and assemblies.

Over recent years more and more customers have benefited from our optics expertise and the competitively priced optical solutions we offer.Vision Optics - custom optical components

The dedicated Vision Optics website www.voptics.com provides further information on these products and services.

As pioneers in designing and manufacturing eyepiece-less microscopes and inspection systems, we know the importance of high quality optics to the success of a product and we understand that not every organisation has optical design capabilities or in-house optical expertise.

In addition to off-the-shelf optical components, we provide a full service solution for your optical requirements. Our experienced engineers will work with you throughout the design and development life cycle, from early concept right through to final design, testing and production.

ghp biotechnology awards 2019 logo

Vision Engineering named Best Stereo Microscope & Measuring Systems Manufacturer

By | News

Ergonomic designs honoured in Global Health and Pharma Magazine’s Biotechnology Awards

Vision Engineering has been named Best Stereo Microscopes & Measuring Systems Manufacturer 2019 by Global Health and Pharma Magazine (GHP).

The awards are based on nominees’ contributions to their sector and winners are selected by a panel of five judges led by an academic.

Vision Engineering was selected based on its continued commitment to innovation and excellence, in particular for its development of the Mantis ergonomic stereo microscope and the TVM non-contact measurement system. The Mantis stereo microscope maximises the comfort of operators by replacing traditional eyepieces with a patented viewing system which allows users to move their heads freely, maintain a natural posture, wear prescription spectacles, and retain peripheral vision of their working area.

First launched 25 years ago, the Mantis stereo microscope has been continually developed and enhanced by Vision Engineering’s in-house research and development team, following the company’s design philosophy which is to make world-class inspection and measurement systems that are easy and comfortable to use.

Mantis eyepiece-less stereo microscopesThe Mantis has continued to evolve in appearance, capability and applicability, maintaining its status as market leader in the medical device manufacture, dental equipment and life sciences markets. The range now includes Mantis Compact, Mantis Elite, Mantis Elite-Cam and Mantis Elite-Cam HD.

The TVM Field of View (FOV) video measurement systems save time and space in the laboratory, and are exceptionally easy to use, to eliminate user errors. TVM’s flat field telecentric lens and collimated sub-stage lighting facilitate instant, non-contact measurement of components of any shape or form, such as injection moulded plastic components, tubes and stents. TVM can be configured to suit specific biotechnological applications and components can be instantly measured within the field of view, without needing to adjust focus or change the position of the subject under inspection.

TVM FOV measuring system with logoGHP is an information sharing platform, used by an international community of members from industry, academia, professional bodies and the public sector, working across healthcare and pharmaceutical industries. GHP Magazine’s Biotechnology Awards recognise innovative companies, clinicians, chemists, researchers, manufacturers and engineers who are leading the field in biotechnology, bio agriculture, bio services and biopharmaceutical industries.

Award co-ordinator, Steve Simpson, GHP Magazine, comments, “Our awards recognise all aspects of the healthcare and pharmaceutical sectors, without whom, many of the life-changing innovations and developments would simply not be possible.”

Commenting on the award, Mark Curtis, managing director of Vision Engineering said:

Our medical and pharmaceutical clients require the utmost assurance of quality. We are delighted to receive this recognition of Vision Engineering’s longstanding and ongoing commitment to making the highest quality precision inspection and measurement systems which are also intuitive and ergonomic.”

Mantis stereo microscope now with extended warranty

Mantis manufacturer’s warranty now extended to 24 months

By | News

We are pleased to announce that the manufacturer’s warranty on all new Mantis eyepiece-less stereo microscopes has been extended from 12 months to 24 months.

All systems bought from 1 December 2018 are covered by the new 2 year manufacturer’s warranty.  The new warranty applies globally.

The Mantis range includes Mantis Compact, Mantis Elite and Mantis Elite-Cam.

Mantis stereo microscope now with extended warrantyThe original eyepiece-less stereo microscope, Mantis revolutionised quality inspection when it launched in 1994.  It was an ergonomic revolution that went on to win numerous design and innovation awards. In the intervening quarter of a century, Mantis has undergone numerous innovations, in appearance, capability and applicability, maintaining its status as market leader.

Mantis serves the needs of customers globally and has applications in electronics, medical device manufacture, plastics, dental equipment, automotive, aeronautics and life sciences markets.

Commenting on the warranty extension, Mark Curtis, Managing Director of Vision Engineering said:

We are delighted to announce the extension of our manufacturer’s warranty on Mantis systems. It is a significant declaration of our confidence in the quality of our product and our commitment to remaining at the forefront of inspection technology quality.”

Vision Engineering Ltd is a global leading-edge manufacturer of patented ergonomic stereo microscopes, digital microscopes and non-contact measuring systems.