DAY TWO | WEDNESDAY, NOVEMBER 6
8:30 REGISTRATION & WELCOME COFFEE
8:55 CHAIRPERSON’S OPENING REMARKS
9:00 CASE STUDY: FORECASTING NET PRESENT VALUE TO SECURE MORE ACCURATE MARKET PREDICTIONS
As new products are added to a company’s portfolio, managers receive an estimated value of worth, which the product manager uses to determine the future value the product will have on the current market, or the Net Present Value (NPV). Although calculating the NPV of a product provides some understandings for future earnings, it is an estimate and cannot provide accurate projections, challenging the product manager to forecast profitability over a long duration of time with little knowledge of the future market trends and product performance. Learning to determine key factors that companies have used to assist with NPV calculations will guide product managers in better projecting the product’s profitability and will support product managers when making decisions for portfolios.
Girish Gangadharan, Senior Director Business & Commercialization Strategy
9:45 CONSIDERATIONS FOR OFF-LABEL COMPLIANCE AND THE EFFECTS OF SOCIAL MEDIA INFLUENCERS ON A PRODUCT
With the increased use of social media to promote devices, paired with the rapid spread of false information via digital channels, product managers need to be more aware than ever regarding what is being said about a product and by whom. With the rise of celebrity endorsements and social media influencer reviews, device companies are seeing an upsurge in misinformed promotion and off-label use. Learning how to withdraw false statements while engaging in a social media driven consumer-base, gives device companies the edge needed when navigating the expanding digital marketing landscape.
Tim Hale, Director of Marketing, NEURONETICS, INC.
10:30 COFFEE AND NETWORKING BREAK
11:00 CASE STUDY: UTILIZING SALES KNOWLEDGE TO TARGET AND IMPLEMENT A CUSTOMER FIRST MODEL
As companies begin to put a customer-first model into place, collaboration between sales and product management teams is essential in getting ahead of the competition and creating a comprehensive strategy to ensure consumer appeal. Product managers are tasked with envisioning the whole portfolio strategy to ensure premarket success, however they miss some key insights into customer concerns, an area the sales team can provide knowledge on through already built interpersonal relationships. The partnership internally can help tailor consumer experiences with go-to market success, changing company strategies to target the correct audiences.
Eric Pearce, Director of Marketing, URGO MEDICAL
11:45 BREAKOUT DISCUSSION: FORECASTING THE IMPACT THE EU MDR WILL HAVE ON THE OVERALL MEDICAL DEVICE INDUSTRY
The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for the sale of medical devices in the European marketplace, making the shift a concern for global executives. Aligning portfolios with the new regulations will be crucial in overcoming challenges in compliance when the EU MDR goes into effect, navigating and addressing the impact to the EU market. Learn to overcome the ramifications the regulation will have on product portfolios, how to manage the removal of products from the EU market, and navigate what the regulation will mean for product managers who are keeping devices in the European market.
- Including Unique Device Identification (UDI)
- Impact to Class 2 vs 3 Medical Devices
- Strategies for the removal of products from the EU
GROUP 1: NOVICE PLANNING STAGE
GROUP 2: INTERMEDIATE PLANNING STAGE
GROUP 3: ADVANCED PLANNING STAGE
12:30 LUNCHEON FOR ALL PARTICIPANTS
1:30 PANEL DISCUSSION: MANAGING THE REGULATORY LANDSCAPE FOR MARKET SUCCESS & PATIENT ACCESS
With the regulatory landscape in constant flux, device product managers look to strengthen relationships with regulatory affairs team members in order to gain insights into approval processes and changes to applicable regulations. With timing being a major barrier for device clearance, product managers rely on regulatory teams and communication from regulators in order to meet targeted launch forecasts and revenue goals. Staying abreast of current regulatory trends allows product managers to secure successful approval decisions leading to a streamlined timeline for a product’s launch within the market.
- FDA’s revamped clearances for medical devices
- 510(k) Clearances
- Initiatives with the PMA application
- Evaluation of Automatic Class III devices
- Objective performance criteria
Jessica Ringel, KING & SPALDING
Quynh Hoang, KING & SPALDING
2:15 CASE STUDY: UNDERSTANDING THREATS WITHIN A DEVICE PORTFOLIO TO HANDLE PRODUCT CONCERNS EFFICIENTLY
Medical devices are increasing connections to the internet, hospital networks, and other technologies to provide features that improve health care and increase the ability of HCP’s to treat patients, in turn creating a higher risk of cybersecurity threats within the enterprise. As the medical device industry moves forward, it is essential for product managers to prepare for the changes not only within the regulatory landscape when addressing cybersecurity, but executives must also build upon relationships with customers to ensure safety and protocol concerns are reduced. Through understanding the major threats within a product portfolio, device organizations are more equipped to tackle the pressures head-on and alleviate consumer concerns immediately.
- Conveying product security as a product value-add
- Review of potential device product cyber threats
- Out-reach to customers to review safety protocols
- Security considerations in legacy product management
Steve Abrahamson, Senior Director of Product Security, GE HEALTHCARE
3:00 THE EVOLUTION OF REGULATORY STANDARDS TO ADDRESS AI AND MACHINE LEARNING BASED MEDICAL DEVICES
With AI-based devices coming to market, the FDA is looking into a proposal that would shift the current approval process from the traditional step-by step method to an ongoing device monitoring strategy. Through more direct interaction with the FDA and customers, product managers will be able to ensure safety and effectiveness are still at the forefront of the device & launch initiatives follow and adhere to new requirements. Innovation is the lynch pin for moving the medical device industry forward and it is essential for product managers to prepare for the changes not only to the regulatory landscape but to internal operations to ensure the success for new AI-based medical technology.
Dave Saunders, CTO, GALEN ROBOTICS
3:45 END OF CONFERENCE