This industry group comprises establishments primarily engaged in manufacturing medical equipment and supplies. Establishments primarily engaged in grinding eyeglasses and hard contact lenses to prescription, on a factory basis, are included.
AQL in Medical Device Manufacturing and the role of MES in its implementation
AQL Defined: ISO 2859-1 establishes AQL (Acceptance Quality Limit), as a sampling-based method for determining quality through inspection of attributes. In simpler terms, AQL is the maximum number of defects allowed in a given lot above which the entire lot would be rejected, or the lowest level of acceptable quality.
An MES application, configured for the medical device industry, allows for the creation of sampling plans, based on risk and for those plans to be enforced either on a time or counter basis. The application supports AQL and allows the definition of measurement tools, along with their calibration status and switches severity automatically which is an advantage for high mix production facilities. It measures both variable and attribute data points based either on time or counter and can be integrated with material logistics to give users a complete view of the quality as materials move across the production line and are converted into the end product.
Error-Free Assembly of Medical Components
A SUV and a medical device used in a lab aren’t very similar in their looks, but when it comes to manufacturing them, they have a lot in common. For both, factory automation is used to increase production volume while also making sure that production steps are completed precisely. Read on to learn about some ways that sensors are used in life science manufacturing.
Manufacturing Manakins for Medical Simulation and Training
Human patient simulators may mimic the human body with varying degrees of realism—or fidelity—and can be used in almost every aspect of healthcare education. The most effective medical training devices are those that have the ability to create accurate modeling of the underlying structures of the human body and replicating them digitally and physically, noted Alban. It is why Simetri’s anatomical models and medical training aides integrate electronic, mechanical and computational components and turns to materials science for innovations in soft and skeletal tissue.
The roadmap to digitization for Simetri, said Alban, started first on the mechanical side, when mechanical models started to go from sketches to using SolidWorks and 3D models, and then embedding sensors to capture data before writing the related software and then advancing the software development capability.
In another development, software can monitor when skin has been cut, and when and if the correct fascia (connective tissue encasing the muscle) has been cut. That data is transmitted digitally to the manakin, and the physiology model of that manakin is updated as a result of that new data and, therefore, displays new vital signs. “If you will have done it the right way, you will lose pulse at the foot, but if you do this procedure correctly, you will gain back pulse at the foot because you’re allowing circulation to flow through,” explained Alban.
Digital Transformation in Medical Device Manufacturing
The technique gained notoriety as a tool for creating “deepfake” videos on the internet, but it can also be adapted to work with 3D data to customize production of physical products, a concept that Goodfellow has dubbed “GANufacturing.” Glidewell is the first company to use GANs to make better teeth. Dentists often spend considerable time and effort creating custom dental prostheses. Not only does a new prosthesis have to fit a 3D shape that works with the patient’s other teeth, but it also must work well with the overall pattern of the person’s bite. As a result, a prosthesis typically needs to be tested on a dental model and ground to fit. Through GANufacturing, Glidewell can generate a near-perfect, realistic and functional tooth that needs little or no post-processing.
How Augmented Reality Strengthens Biotech Manufacturing
Probably, the biggest advantage of AR is it enables seeing the production process virtually, without the need to be there. “It’s a game-changer for the industry. Individuals can have eyes and ears on site at a moment’s notice to address an emerging issue, or to host routine remote collaboration sessions,” Stracquatanio highlights.
AR can also increase control over the manufacturing process. Pharma and biotech companies cannot afford mistakes during the production phase. A little oversight might lead to serious consequences such as having to start from scratch, which can be very expensive and time-consuming. A recent example is that of Johnson & Johnson’s manufacturing partner Emergent BioSolutions, whose workers erroneously mixed ingredients from two different Covid-19 vaccines; this led to wasting around 15 million vaccine doses.
During a working day, we could see an operator who loads 3D models of biotech instruments, looking at specific pieces and relevant information appearing in the smart glasses or tablet. Meanwhile, another engineer walks up to a machine with a QR code, and instructions pop up in the glasses, facilitating access to the adjustments. A few steps from there, another colleague is looking at batch records, saving values into the system just via voice.