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Microsoft CMO: Using the cloud to improve medtech design, manufacturing and care

David Rhew is Microsoft’s global chief medical officer and VP of healthcare. [Photo courtesy of Microsoft]

Dr. David Rhew, Microsoft’s global chief medical officer and VP of healthcare, has been studying how technology can improve health outcomes for nearly three decades.

His focus has long been on access to care, quality of care, patient safety, improving experiences for patients and providers, and finding ways to improve the overall efficiency of care.

He was previously CMO at Samsung and Zynx Health before that. But his role at Redmond, Washington-based Microsoft (NSDQ:MSFT) — one of the world’s cloud-computing leaders — offers his best opportunity yet to shape the future of medtech.

Rhew spoke with Medical Design & Outsourcing as part of an ongoing series of conversations about cloud computing’s contributions to medtech and the potential ahead. The discussion that f…

Japanese precision prototypers and fabricators offer to fill supply chain gaps fast

The Japan External Trade Organization and a Chicago-area Minority Business Enterprise are partnering to offer one-on-one meetings with 10 Japanese precision prototyping and fabrication experts.

The Japanese companies work with companies such as DENSO, Omron, Mitsubishi, Mercedes, Honda, Boeing, Stryker Japan and the Department of Defense, according to Itasca, Illinois-based ITA.

The companies are: MACRW, TDI Electronics, Aomi Precision, ISS Dainchi, Nakano, Koyo High Precision, Daytech Trading, Kyowa Industrial, Fujiseiki, and Nakata. They can provide small quantity precision parts shipped quickly via FedEx or UPS to help fill supply chain gaps as global disruptions persist. Some of the companies already have operations in the U.S.

The companies are available for free 30-minute Zoom or Microsoft Teams meetings now through Feb. 24.

Attendees can register through ITA’s website; clicking through the registration process yields more information …

Moody’s warns of continued supply chain and labor problems for medtech

As the latest COVID-19 wave recedes, testing demand will likely follow. [Image courtesy of Amazon]

Moody’s warned investors that supply chain disruptions and healthcare worker shortages will continue to pressure medical product and device companies in 2022.

The good news from the Moody’s Healthcare Quarterly report? The supply chain issues are manageable, with Moody’s estimating that transportation costs average less than 3% of revenue for most large, rated device companies, which won’t eat up too much of those companies’ 20% profit margins.

The bad news: Healthcare labor shortages show no sign of improvement, with nearly a quarter of U.S. hospitals reporting critical staffing shortages in early January due to the omicron COVID-19 variant, according to the U.S. Department of Health and Human Services.

“Large numbers of nurses and other skilled workers will conti…

Addressing vulnerabilities in the medical product supply chain

Image courtesy of Pexels

While the medical product supply chain has always been subject to vulnerabilities, those weaknesses were laid bare early in the COVID-19 pandemic. Drug and medical device supply chains have historically been susceptible to factors such as a lack of supplier redundancy, components, active pharmaceutical ingredient (API) or finished product manufacturers. But pandemic-driven sourcing and workplace disruptions magnified these pain points, resulting in the ongoing problems that have persisted for the past two years.

Although the root causes are complex and the possible solutions numerous, important developments at the U.S. Food and Drug Administration (FDA) have led to increased transparency about drug and medical device shortages. Although this transparency is a promising starting point for formulating short- and long-term supply chain solutions, strong policy development, planning and …

4 clinical trial predictions for 2022

Image courtesy of Pixabay

The clinical trial space had one of its most significant disruptions in decades in the early days of the pandemic. Now, some clinical trials are normalizing, but decentralized clinical trials are also growing.

To learn more about what is likely on the horizon for clinical trials in 2022, we reached out to Jan Pieter Kappelle, VP of strategy of 4G Clinical. Kappelle is optimistic about continued growth of decentralized clinical trials and the spread of digitization throughout the supply chain.

1. DCT trial designs will continue to grow

The adoption of decentralized clinical trials (DCT) surged in the early days of the pandemic. “When we started up in this pandemic almost two years ago, studies really ground to a halt,” Kappelle said. As drug companies scrambled to adapt, many embraced a direct-to-patient (DtP) model for patients.

Lessons in life or death logistics

Cell therapy image from Wikimedia Commons

The cell and gene therapy market continues to advance, thanks to its promise to treat cancers and other severe diseases. While the pandemic has had a negative impact on companies specializing in cell and gene therapies, it has also catalyzed interest in cold-chain logistics while also highlighting the promise of new therapy types.

Organizations interested in expanding their focus on cell and gene therapies can learn from best practices from organizations specializing in high-stake logistics.

Push for standards and collaboration

The initial focus on transporting mRNA vaccines at below-normal temperatures “highlighted the need for some sort of standardization,” said Ray Hornung, senior manager, logistics and emergency preparedness at Be The Match BioTherapies (Minneapolis).

Ray Hornung

While t…

How direct-to-patient can impact pharma supply chains

Image courtesy of Pexels

In the wake of COVID-19, telemedicine has become the only means for delivering patient care for many physician groups. As healthcare providers adapted to treating patients virtually, patients likewise adapted to disrupted routines. For those dependent on prescription medication to treat or manage a medical condition, “going to the pharmacy” was an errand replaced by curbside pickup, delivery service or mail order.

Necessity is the mother of adoption

With no other options, the physician-patient interaction went digital after years of discussion about the promise of telehealth. CMS approval of pilot hospital-at-home programs accelerated adoption further. These alternative care sites kept patients free from the risks of hospital-acquired infections and reserved empty beds for possible surges. Program results largely demonstrated that unchanged patient outcomes outside of the hospital se…

Medtronic CFO offers supply chain update as medical device industry concerns mount

Medtronic CFO Karen Parkhill [Photo courtesy of Medtronic]Medtronic (NYSE:MDT) was among the participants in a White House semiconductor summit last week to address the continuing global shortage of electronic chips, but CFO Karen Parkhill says the world’s largest medical device manufacturer is not in same dire straits as chip buyers in other industries.

Medtronic’s supply chain is “holding up OK, but we’re seeing pressures like everybody else,” Parkhill said Friday in an interview with Medical Design & Outsourcing.

Get the full story at our sister site, Medical Design & Outsourcing.

Medtronic CFO offers supply chain update as medical device industry concerns mount

Medtronic CFO Karen Parkhill [Photo courtesy of Medtronic]

Medtronic (NYSE:MDT) was among the participants in a White House semiconductor summit last week to address the continuing global shortage of electronic chips, but CFO Karen Parkhill says the world’s largest medical device manufacturer is not in same dire straits as chip buyers in other industries.

Medtronic’s supply chain is “holding up OK, but we’re seeing pressures like everybody else,” Parkhill said Friday in an interview with Medical Design & Outsourcing.

“Semi-conductors are an issue. Resins are an issue,” she said. “I think it helps that we’re a medical device manufacturer that’s producing life-saving technology … because when push comes to shove, I think we’re more important than new cars coming off the line, for example. We haven’t necessarily pulled that card, but I do think that that could help if…

FDA establishes authorities to boost medical device supply chain

The FDA announced as part of its annual budget that it will include $21.6 million for a new Resilient Supply Chain and Shortages Prevention Program (RSCSPP).

Funding from the RSCSPP for the Center for Devices and Radiological Health (CDRH) will provide — the FDA says, for the first time — resources to establish a permanent program for U.S. supply chain resilience for medical devices.

Get the full story at our sister site, Medical Design & Outsourcing.

FDA establishes authorities to boost medical device supply chain

The FDA announced as part of its annual budget that it will include $21.6 million for a new Resilient Supply Chain and Shortages Prevention Program (RSCSPP).

Funding from the RSCSPP for the Center for Devices and Radiological Health (CDRH) will provide — the FDA says, for the first time — resources to establish a permanent program for U.S. supply chain resilience for medical devices.

Having implemented the Coronavirus Aid, Relief and Economic Security Act (CARES Act) in 2020, the FDA observed weaknesses in the medical device supply chain and the dependence on foreign medical devices. The implementation of the RSCSPP aims to take resources and expand authority to ensure that the U.S. is prepared to secure its medical device supply chain.

The focus of the funding as part of the FDA’s fiscal 2022 budget centers around strengthening the domestic supply chain through investments in preventive measures, identifying potential medical product supply shortf…

Biden administration wants to boost funding for new pharma manufacturing processes

President Joe Biden [Image courtesy of the White House]The Biden administration today released findings from 100-day supply chain assessments, determining the need to boost pharmaceutical manufacturing.

According to a fact sheet, the administration plans to take immediate action to “address vulnerabilities and strengthen resilience” with its effort to take on near-term supply chain disruptions for four products: semiconductor manufacturing and advanced packaging; large capacity batteries, like those for electric vehicles; critical minerals and materials; and pharmaceuticals and active pharmaceutical ingredients (APIs).

Get the full story at our sister site, Pharmaceutical Processing World.