26 October, 2016 Lisa Weeks, Marketing Communications Specialist MasterControl
For those of you unable to attend, here are my top seven takeaways from AdvaMed 2016:
Last week, I attended AdvaMed 2016, the leading medtech conference in North America. This year’s conference was the biggest yet, with more than 2,650 medtech professionals descending on Minneapolis for three days (October 17-19) of educational sessions, lively panel discussions and inspiring patient stories. As the birthplace of the modern medical device, and home to nearly 1,000 health technology companies, Minneapolis was a suitable host location to celebrate the tenth anniversary of the conference. This year’s programming covered the industry’s most pressing topics including policy, reimbursement, big data and digital health
#1: The Rise of the Health Care Ecosystem
The FDA was well represented at this year’s conference. In session after session, members of the Agency’s Center for Devices and Radiological Health (CDRH) emphasized the need to move toward a health care ecosystem in which regulators, manufacturers, payers, providers and patients work together to improve the country’s floundering health care and reimbursement systems. This can only happen if industry (and the FDA) is willing to embrace transparency and collaboration. Collaboration was THE key word of AdvaMed 2016.
#2: CDRH’s Strategic Priorities for 2016-2017
Dr. Jeffrey Shuren, the director of the CDRH, gave attendees a comprehensive overview of the Center’s three strategic priorities for this year and next year. They are:
- The establishment of the National Evaluation System for health Technology (NEST): Introduced in 2012, the NEST proposal was elevated to a strategic initiative this year. NEST aims to establish a cooperative network of partners (e.g., federal partners, health care system, device manufacturers, payers and patients) working together to use real-world data, advanced methodologies, and good governance to improve the state of medical device evidence generation. The hope is that linking and synthesizing data across the medical device landscape, including clinical registries, electronic health records and medical billing claims, will support faster product approvals/clearances, foster innovation and facilitate patient access. Shuren was quick to stress that the shared data will not be owned by the FDA. An independent, transparent coordinating center will set the rules of data sharing and support the system’s development and implementation. Last month, the FDA awarded the Medical Device Innovation Consortium (MDIC) $3 million in seed funding to establish the Coordinating Center for NEST.
- Partner with patient: The CDRH aims to increase engagement with patients substantially over the next two years. For example, it has committed to having 50 percent of its staff interacting with patients as part of their job duties by year-end. By December 31, 2017, the goal is to have 90 percent of CDRH employees interacting with patients. According to Shuren, the CDRH is committed to “listening to what the patient wants,” and he urged manufacturers to be willing to do the same, singling out the need to design clinical trials around patient lifestyles to increase participation. Next year, the CDRH intends to launch a Patient Engagement Advisory Committee to discuss high priority topics regarding patient input in the total product lifecycle.
- Promote a culture of quality and organizational excellence: While Shuren concedes that the CDRH cannot “mandate quality,” the Center does recognize the need the do a better job of championing the adoption of a culture of quality and organizational excellence with its customers (patients, industry and health care professionals), as well as within the CDRH itself. Several efforts are in place to accomplish these goals. Through the Case for Quality Initiative, Voluntary Compliance Improvement Program and the Medical Device Single Audit Program, the Center has been working with manufacturers and other stakeholders to identify and remove key impediments to quality. Internally, the CDRH will continue to implement its Quality Management Framework, which was introduced in 2013. It also plans to develop education and training for staff members to improve organizational excellence and to conduct a Baldridge Performance Excellence Criteria self-assessment to measure its progress.
#3: Industry Wants More Guidance on Off-Label Use Communications
How to compliantly engage in off-label use communications continues to be a major stumbling block for device companies, and they want the FDA to supply more guidance. (Most of the existing guidance in this area pertains to pharmaceutical drugs.) Device manufacturers contend that the ability to exchange scientific information with health care providers and patients is essential to advance the public health, but they feel shackled in getting patient safety information to industry. While most manufacturers err on the side of caution and have strict policies for off-label communications, others are looking to revise their policies in light of recent legal cases (e.g., the February 2016 acquittal of Vascular Solutions’ CEO Howard Root) in which device companies were able to successfully challenge FDA off-label use restrictions as infringements of commercial free speech. In a good faith effort to gather feedback from device makers on difficult uses, the FDA will hold a Part 15 hearing on November 9-10, 2016.
#4: Cost Control Will Continue to Drive Innovation
In the past, small improvements to medical products would translate to big profits for the device company that was first to market. Today, health care payers are scrutinizing the precise gains in the outcomes from an improved product. The value of a device is determined by how well it helps to control the overall cost of care, not by enhanced performance. In the New Health Economy, devices that can satisfy this sharpened focus on cost containment will attract investors (and payers).
#5: U.S. and Global Inspection Practices Need Improvement
While the regulatory landscape is in a state of flux, one thing remains constant: the tension between device makers and the FDA over how to handle inspections. According to the AdvaMed working group assembled to address inspections, there are many issues: field investigators often show up late, unannounced, or when the subject matter expert (SME) is not available; investigators do not want to hear about process (and therefore don’t possess a true understanding of a company’s process); investigators fail to provide a daily wrap-up or put little detail into 483s—the list of grievances goes on and on. FDA staff churn is partly to plan for the problem, as is the lack of dialogue between manufactures and investigators. However, the FDA is hoping that its program alignment effort, an attempt to provide more cross-center coordination on enforcement/compliance matters, as well as its planned operational changes, in which investigators will be specialized and conform to a more standardized inspection protocol, will help ease some of the tensions.
#6: ISO 13485: 2016 May Be Revised in 2019!
When asked whether industry should expect any short-term changes to the newly revised ISO 13485 standard, Eamonn Hoxey, Vice-President, Medical Devices Quality & Compliance Strategic Programs, Johnson & Johnson Medical Ltd., said…maybe. Hoxey noted the big issue behind ISO 13485: 2016—that it does not follow the new high-level structure—was a bone of contention amongst the ISO technical committee. As a compromise, the committee agreed to a systematic review of the newly revised standard in three years (2019). If the results of the review indicate that the standard needs to be revised, revising the standard will be a huge undertaking. Hoxey also mentioned that the long-awaited ISO 13485: 2016 Implementation Handbook will be available in March of 2017.
#7: Medical Devices Changing Business Model: Service-based Solutions
The medtech industry is recognizing the need to make products more consumer-centric, which means incorporating the consumer perspective in product design and expanding their business models. As such, according to PwC Health Research Institute, half of the established medtech companies are expanding their portfolios to include service offerings. Data that documents and analyzes the delivery of health care are as important as the device itself. New entrants are focused on building customer convenience into the development and design of their products and solutions.
I will be expanding on many of these key takeaways in upcoming posts—so stay tuned.
Lisa Weeks, a marketing communications specialist at MasterControl, writes extensively about technology, the life sciences, and other regulated environments. Her two decades of marketing and advertising experience include work with McNeil Pharmaceuticals, SAP AG, SCA Mölnlycke, Crozer-Keystone Health Systems, and NovaCare Rehabilitation/Select Med. Her work has appeared in numerous industry publications, including Medical Product Manufacturing NEWS (MPMN), Medtech Pulse, Risk Insights, MD+DI, Pharmaceutical Processing, Genetic Engineering & Biotechnology News (GEN) and PharmaTech.