Boston Consulting Group Archives - Medical Design Sourcing

Telepresence technology is accelerating medical device development while broadening and deepening relationships between medtech companies and their customers

An expanding customer base, rapidly advancing technology and intense cost pressures are driving medtech companies to use surgical telepresence to cost effectively meet customer needs, enhance customer relationships, develop new products faster and empower healthcare providers to raise the standard of care.

By Daniel Hawkins, Avail Medsystems

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

The medical technology medtech industry is relentlessly challenged to efficiently maintain growth, fund innovation, and provide an appropriate return to shareholders. Over the last decade, this has become increasingly difficult due to myriad challenges resulting from rapid expansion in the number of sites of service, declining reimbursement, relentless pricing pressures and increasing technical complexity across the industry.

Throughout my 30-yea…

Has the CE mark lost its appeal for novel medical device developers?

Medtech companies are increasingly looking to the FDA instead of Europe’s CE mark when launching novel products, according to a new report.

“Historically, the CE mark has been the preferred route for novel medical technology registration, since its processes were faster, cheaper and more predictable. The situation is now reversed,” wrote the authors of the study, published by Boston Consulting Group and the UCLA Biodesign innovation hub.

They surveyed and interviewed leaders and executives at 102 companies that have achieved registration or approval of a combined 105 novel technologies. A little more than half of the respondents said they are deprioritizing the CE mark relative to FDA approval.

Of the companies surveyed, 90 are headquartered in the U.S. and nine in the EU. One-fifth of the companies are publicly traded.

Industry executives described product registration and approval as “cumbersome and uncertain” under…

How much time and money does it take for FDA 510(k) clearance versus De Novo classification?

If you’re developing a new medical device and want to know how much time and cash it could take to get FDA 510(k) clearance or De Novo classification, a recent report offers some guidance.

Boston Consulting Group and the UCLA Biodesign innovation hub questioned leaders at 102 different companies that have achieved registration or approval of a combined 105 novel technologies. Ninety of the companies are headquartered in the U.S. and nine in the EU. One-fifth of the companies are publicly traded.

Survey questions and interviews yielded detailed cost information for 50 products that successfully navigated the 510(k) pathway at a median cost of $3.1 million and 13 products that won De Novo classification at a median cost of $5 million.

“Cost is dictated by many factors, including but not limited to the inherent novelty of the design, whether clinicals are required, and whether the product consists of software or hardware,” the report said.…