Connecting the Dots in Medical Device Outsourcing

San Francisco is globally renowned for many things: The Golden Gate Bridge (its color, international orange, was actually a primer used to protect the steel during transit), Ghirardelli chocolate, the TransAmerica pyramid building, and the “Painted Ladies” (that row of colorful Victorian homes shown at the start of the 1980s television series “Full House”).

Far less famous—at least to non-healthcare folk—is the Bay Area’s robust medical device manufacturing hub. The city and surrounding region has historically been one of several centers of American medtech prowess, along with Massachusetts, Minnesota, and Southern California. The North Bay region outside San Francisco is peppered with device firms, while more than 100 are located within the city itself.

It seems only logical then for this bastion of medtech dominance to host this year’s MPO Summit, taking place Oct. 3-4 at the Marriott San Francisco Waterfront Hotel. As it has in years past, the event will closely examine medical device outsourcing and the critical factors currently impacting the industry, expected to reach $210.5 billion worldwide by 2026, according to Grand View Research Inc.

The Summit will begin with the annual “State of the Industry,” a session that has become an attendee favorite in recent years. Mark Leahey, president and CEO of the Washington, D.C.-based Medical Device Manufacturers Association, will provide an update on the issues and factors in the nation’s capital that are impacting outsourcing, including current device tax repeal efforts, and the drive for greater FDA and CMS reforms. 

The importance of globalization and crafting an international business strategy is the focus of a session led by Florence Joffroy-Black, CEO, president, and co-founder of MedWorld Advisors, and Dave Sheppard, the firm’s principal and co-founder (authors of C-Suite on pg. 34). The pair will discuss ways device companies can maximize their chances for success in various regions around the world while concurrently adjusting to the perpetually changing medtech environment.

Mihir Torsekar, an international trade analyst with the U.S. International Trade Commission (and author of the Supply Chain column on pg. 28), will keep the focus on globalization with a session that explores recent trade actions and their affects on the medical technology supply chain. He will address the shifting conditions in low labor cost locations, America’s changing relationships with its trade partners, and trade actions that threaten to impact the medical technology industry and its worldwide dominance. Torsekar’s presentation will discuss the implications for U.S. medtech supply chains in light of these recent developments.

Globalization will factor into a session headed by Christine Scifert, co-founder of MRC/X LLC (she is featured in the Best Practices column on pg. 40). The medical device industry’s regulatory landscape is changing, leading to a “perfect storm” of deadlines and headaches for many companies. Most notably among these regulatory changes is the European Union’s replacement of its longstanding Medical Device Directive with the Medical Device Regulation. This new law requires the review of most devices to be sold on the continent regardless of whether they are currently on the market. Within the same time frame, the medical device single audit program (MDSAP) has been implemented and is now required to market devices in Canada. Moreover, the FDA is enforcing stricter biocompatibility documentation into its 2016 guidance as ISO 13485:2016 transition audits continue to occur. Consequently, EU notified bodies are going to be overwhelmed with the sheer amount of work coming their way. Scifert’s presentation will help companies prioritize and ensure they focus on the right tasks at the right time. 

The first day’s panel discussion will focus on partnerships between the medical device industry and Silicon Valley, exploring how emerging players are changing the sector and the ways in which clinicians are interacting with patients. Led by John Carlson, president of Health Solutions for engineering/consulting firm Flex, this panel will discuss the design, development, data privacy, and regulatory challenges the medtech/Silicon alliances face and ways to address these issues. The panel also will identify the opportunities that have been enabled through these partnerships.

The second day of the Summit will begin with a discussion of product security and supply chain management. OEM and healthcare delivery organizations have typically not been aligned about protecting patient safety from cybersecurity threats. But the Health Sector Coordinating Council (HSCC), a cross-industry coalition partner with government, has brought together key stakeholders to acknowledge a shared responsibility and develop a joint security plan. Greg Garcia, the HSCC’s executive director for cybersecurity, will discuss the toolkit the agency is set to release; he also will provide pointers on ways companies can better incorporate cybersecurity into their product platforms.

The Summit will conclude with a discussion about the skilled labor shortage impacting medtech. American manufacturers will need to fill 3.5 million jobs by 2025, but 2 million of those spots will likely remain vacant due to the lack of skilled trade workers, experts predict. Perception is just part of the problem—the negative stereotype that skilled trade jobs require little skill or thinking, and offer no career advancement still prevails. Medical Product Outsourcing associate editor Sam Brusco will lead a discussion about the steps academia and industry must take to combat the skilled labor shortage and cultivate a passionate medical manufacturing workforce.