The Briefing Room – Medical Alley Association

The Briefing Room

3D Printing: Product Liability Risk at the Point of Care

By Joe Winebrenner and Andrew Jackson Over the last decade, 3D printing (also known as “additive manufacturing”) has revolutionized the medical industry. The FDA has reviewed hundreds of medical devices made with 3D printers, including orthopedic and cranial implants, surgical instruments, dental restorations, and prosthetic devices. With greater frequency, 3D printing technology is being incorporated […]

Launching a Medtech Product? Have Your Regulatory, IP and Governance Affairs in Order Before Engaging Investors

By Walter Linder, Amy Judge-Prein, and Jonathan Zimmerman Investors in medtech companies are willing to take risks. However, they will expect their investment to be put to effective use with defined objectives, and their diligence will focus on identifying potential impediments to those objectives. Because momentum is important when seeking investment, it is critical that […]

Telehealth State of the States

By Sarah-Lloyd Stevenson In the Midwest and across the country, state governments are recognizing that telehealth is a viable and affordable option for providing healthcare services to patients and their communities. In recent years, nearly every state has taken a step toward improving the coverage or reimbursement of telehealth. However, policies look very different from […]

Run a Compliant Speaker Program, Avoid Costly Penalties and Criminal Prosecution

By Gary Rom and Nicholas A. Klinefeldt You’ve likely heard of the $225 million global resolution opioid manufacturer Insys Therapeutics reached with the Department of Justice (DOJ) on June 5, 2019 to settle misconduct charges stemming from its speaker program practices. You’ve also likely thought that your company would never engage in the same behavior. […]

As Mobile Health Tech Rises in Popularity So Do the Privacy and Security Risks

By Paul H. Luehr and Doriann H. Cain Electronic medical devices have long been a part of healthcare. From x-ray machines to infusion pumps, these devices have helped push major advancements in clinical care. But increasingly, we see healthcare technology moving out of controlled clinical settings. From Bluetooth-enabled blood pressure cuffs to fitness bands and […]

Patients and Primary Care Physicians at the Center of New CMS Innovation Models

By David O. Ault and Steve Lokensgard Value-based care is a term used frequently in healthcare to refer to care that is of equal or higher quality for the same or lower cost. In a value-based model, payers provide financial incentives to physicians and hospitals to figure out how to replace a knee for the […]

“AI” And “IP”: Two Small Letters with Big Impact

By Lauren J.F. Barta and Timothy E. Grimsrud Artificial Intelligence is already used in healthcare in a multitude of ways, including robotic-assisted surgery, virtual nursing assistants, diagnostics, drug discovery, hospital workflow, consumer integrated health, and personalized medicine, and its use is only expected to grow.[1] AI technologies are able to sense, comprehend, act, and learn—this […]

You Can’t Spell Medical Without “AI”

By Lauren J.F. Barta and Timothy E. Grimsrud Innovative medical and healthcare applications of artificial intelligence (AI) are everywhere:  Mayo Clinic is engaged in a pilot program using a customized version of IBM Watson to match patients to its clinical trials.  Cleveland Clinic is using AI for surgical volume forecasting, and Johns Hopkins is using […]

Know Your Rights Before Publicly Discussing a Patent or Patent Application

When police arrest a suspect, they are required to advise the suspect of his right to remain silent. A recent decision on CRISPR from the U.S. Court of Appeals for the Federal Circuit suggests that applicants for U.S. patents could also benefit from remaining silent.  Under U.S. patent law, a person is entitled to patent […]

The Legal Risks of Genetic Data

By Christin Jaye Eaton and Jeff Wojciechowski Recent scientific and technological breakthroughs have enabled medical product manufacturers to analyze genetic data, which can unveil links between genetic traits and certain reactions to drugs or other products. But when must manufacturers use that data? What action must a manufacturer take when genetic data illuminates patient risk? […]

Keep your finger on the pulse of Medical Alley from anywhere with the ALLEY NEWSLETTER