Incorporating medical technology risk management into your business strategy

The rapidly evolving medical technology landscape is causing an increase in compliance risk for many MedTech organizations. But a targeted, proactive approach can help deliver business value in addition to helping reduce risk.

In this installment of our “Let's change the way we see risk” series, Tiffany Gallagher, Health Industries Risk and Regulatory Leader, PwC US, and Denis Jacob, MedTech Risk Management Managing Director, PwC, discuss the expanding compliance landscape for medical technology organizations and how a “compliance by design” approach can help protect organizations from risk while increasing efficiency.

Change is the only constant in today’s dynamic healthcare technology industry. Recent developments include wearable devices that can monitor your health, implants that help reverse paralysis and 3D printers that can help produce cells and living tissue. But alongside these exciting technological advances, MedTech organizations face many additional risk management challenges, such as geopolitical threats, rising stakeholder expectations, bribery and kickback risks, cyber and privacy issues, export controls, sustainability and customer advertising.

These challenges are highly interconnected, and each one can have far-reaching implications across the enterprise, putting an organization’s brand and reputation in jeopardy. For example, a company launching a new wearable device should establish and maintain a well-defined risk governance framework that incorporates data security and privacy, interactions with healthcare professionals (HCPs), third-party risk management, regulatory, quality, consumer protection and responsible sourcing. Launching internationally adds more complexity, since regulations may differ significantly around the world and often require local expertise.

Taking a proactive approach to compliance 

To respond to increasing risk complexity, many leading MedTech companies are proactively incorporating compliance risk management into their business strategy. This can help enable better compliance and help grant a competitive advantage by establishing early alignment on the ideal risk management approach. With a “compliance by design” model — where compliance risk is assessed and mitigation plans are created as part of a business plan — companies can help avoid process overlaps, reduce interruptions and distractions and increase efficiency.  

A compliance by design approach can also accelerate an organization’s strategy by making it possible for companies to evolve from a manual, reactive, process to a proactive, strategic approach — one that’s aligned with the latest regulatory requirements.

When it comes to interactions with healthcare professionals, these exchanges are essential to the safe and effective use of medical technology. The introduction of innovative and disruptive technology further reinforces the need for continuous dialog with the scientific community to raise awareness and promote adoption. However, such interactions typically require proper compliance oversight to make sure the highest ethical and compliance standards are maintained to help mitigate risks related to potential abuses in areas such as hospitality and fair compensation. 

Healthcare compliance officers can support a company’s goals by proactively meeting with marketing, legal, finance, medical affairs and medical education teams to help establish HCP engagement needs and plans, create and maintain clear policies and internal processes for vetting, contracting and compensating HCPs.

Enhancing compliance risk management resources

The right approach to compliance resource allocation often requires robust governance and a clear understanding of the organization through the perspective of multiple lines of defense. MedTech organizations should have a holistic view into how risk mitigation plans are planned, executed and monitored.

PwC has solutions that can bring together critical consulting, technology and managed services capabilities so clients can develop a value-based approach to compliance risk management. With Interactions Hub, a PwC product, it’s possible to unlock value while managing risk and delivering the experience internal and external stakeholders expect.   

Learn more about how Interactions Hub can help automate and streamline HCP interactions and help organizations stay compliant with regulations worldwide.