software Archives - Medical Design Sourcing

Avail Medsystems plans to roll out first third-party software integration

The Avail Medsystems console brings remote experts into the operating room virtually. [Photo courtesy of Avail Medsystems]

Avail Medsystems is testing a third-party software integration that it plans to launch in the coming months.

Avail executives said they hope it will be the first of many partnerships with medical technology developers of software or algorithms that could be useful in the operating room.

Avail CEO Daniel Hawkins expects to launch the software integration in the first quarter of 2023, he told Medical Design & Outsourcing after a panel discussion at DeviceTalks West in Santa Clara, California. He declined to name his company’s partner, but offered some details as the product goes through UI and customer experience testing.

“A remote user can pull up that software and optimize the workflow in a specialty category that really benefits from workflow enhancement,̶…

Avail Medsystems plans to roll out first third-party software integration

The Avail Medsystems console brings remote experts into the operating room virtually. [Photo courtesy of Avail Medsystems]

Avail Medsystems is testing a third-party software integration that it plans to launch in the coming months.

Avail executives said they hope it will be the first of many partnerships with medical technology developers of software or algorithms that could be useful in the operating room.

Avail CEO Daniel Hawkins expects to launch the software integration in the first quarter of 2023, he told Medical Design & Outsourcing after a panel discussion at DeviceTalks West in Santa Clara, California. He declined to name his company’s partner, but offered some details as the product goes through UI and customer experience testing.

“A remote user can pull up that software and optimize the workflow in a specialty category that really benefits from workflow enhancement,̶…

FDA issues draft guidance on medical device production and quality system software assurance

The FDA wants feedback on its newly issued draft guidance for practices relating to computers and automated data processing systems used as part of production or quality systems.

The FDA is taking comments on its new draft guidance, “Computer Software Assurance for Production and Quality System Software,” until Nov. 14.

The agency’s goal is to offer recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or quality systems. FDA said the new guidelines follow manufacturing advances in areas such as automation, robotics and simulations that can improve the quality, safety and availability of medical devices.

FDA said medical device manufacturers have asked not only for greater clarity on validating production and quality software, but also a “more iterative, agile approach.”

RELATED: Taking the extra steps to ensure medical device quali…

Why risk it? Meticulous software testing can save the lives of medical device users

[Image by Pexels via Pixabay]

Jay Noble and Stephanie Van Ness, Integrated Computer Solutions

Software testing is not optional.

Let me repeat: Software testing is not optional!

Software defects are one of the most common reasons for clinical or consumer medical device recalls, and serious issues stemming from software errors abound. A 2020 study by the Australian government identified a rash of problems, such as errors related to resilience and reliability, including software that crashed, froze or functioned only intermittently — or failed to respond at all.

How do software errors present themselves in the real world? Here’s just one example of software gone wrong. In 2016, clinical software used widely by practitioners in the U.K.’s National Health Service had been miscalculating patients’ risk of heart attack, errors that had gone undetected since 2009. As a result, at least 300,000 hear…

Honeywell acquires MES firm Performix

Honeywell (NASDAQ:HON) will integrate manufacturing execution system (MES) software offerings from Performix Inc. into its portfolio of offerings for life science companies.

Financial details of the transaction were not disclosed.

Houston, Texas–based Performix specialized in creating MES software for pharma and biotech companies.

Late last year, Honeywell announced its intent to acquire privately-held Sparta Systems (Atlanta), a provider of quality management software, for $1.3 billion.

Honeywell’s life sciences strategy is to offer a comprehensive software suite that can integrate multiple systems into a single manufacturing ecosystem, according to Ujjwal Kumar, president of Honeywell Process Solutions. “Honeywell can now offer customers a tailored solution designed for their specific industry that combines process automation, production management, quality management and data analytics into a single software suite,” he said in a statement.

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Novatek requalified as a supplier for Boehringer Ingelheim’s aseptic manufacturing facilities

Environmental monitoring software developer Novatek (Quebec, Canada) has extended its partnership with Boehringer Ingelheim. In particular, Novatek has announced that it has won reapproval from the drugmaker to use its software in its human pharma, animal health and biopharmaceutical aseptic (sterile) manufacturing sites internationally.

“We are excited to announce that Novatek is requalified as an approved supplier of Boehringer Ingelheim for Novatek’s Environmental Monitoring Software around the world,” said Mazda Famili, vice president quality at Novatek International, in a statement.

Ingelheim, Germany–headquartered Boehringer Ingelheim is the world’s largest private pharma company.

Boehringer Ingelheim selected Novatek as an approved vendor and partner in 2017.

Novatek’s software supports the management of multiple critical aspects within quality-controlled environments. Novatek’s environmental monitoring management software supports labeli…