INTRODUCTION
Uncertainty in Healthcare Supply Chains and The Impact on Patient Care
More than ever before, supply chains face greater threats of disruption. Major events like the COVID-19 global pandemic and the resulting shortage of semiconductor chips, the closure of the Suez Canal, and the Russian invasion of Ukraine have demonstrated the fragility of global supply chains that has a far reaching impact on sectors everywhere.
The healthcare industry is not immune. Medical original equipment manufacturers (OEMs) need to understand these risks—and how to minimize and/or mitigate them.
“The pandemic highlighted how important medical devices are to our health care system and public health. The shortages hit hard... for such critical devices as ventilators, test supplies, and even some of the equipment needed to administer vaccines. When devices go into shortage, patients everywhere are impacted.”
- U.S. Food & Drug Administration1
Supply chain disruptions are not merely an inconvenience - they can devastate a company’s bottom line while also impacting patients who require life-saving medical devices.
- Resulting delays in production and product release can cause lasting damage to revenue and reputation
- Interruption of supply chain and alternative components may impact the efficacy, safety and longevity of medical devices
- Ad-hoc suppliers in the healthcare supply chain without proper qualification and management may lead to enforcement actions from the US Food and Drug Administration (FDA) and other international regulatory bodies.
- The interconnectivity of many medical devices can introduce additional and liabilities, such as cybersecurity and data privacy, from suppliers to OEMs
- Counterfeit parts pose a significant risk to overall product quality and regulatory compliance, and can also negatively impact patient outcomes and safety
But perhaps most significantly, supply chain volatility can delay the delivery of life-saving medical devices and equipment to healthcare professionals around the world.
Fortunately, medical device companies can anticipate uncertainties and strengthen resilience to cope with the inevitable supply chain disruptions.
Strategies to Mitigate Supply Chain Disruptions:
Anticipate and Proactively Manage Risk
Align Sources Early
Design for Supply Chain
Qualify Alternative Supplier Base
Plan for Scale