As we look to the future, the medical device industry faces a world of opportunity. New markets continue to emerge, especially those utilizing advances in IoT and AI to improve medical outcomes. This leaves government regulators playing catch up—but they always do.
Much uncertainty lies ahead. New regulations and standards are constantly emerging, healthcare dynamics are evolving, reimbursement rules are becoming more complex, and companies are facing an increasingly competitive landscape. This challenging climate requires medical device companies to reduce costs, streamline their operations and innovate more quickly. Tapping solutions like QAD ERP to manage such a dizzying array of changes is always a smart move.
In recent years, changes to the global regulatory environment have burdened medical device companies with greater accountability to authorities and higher costs, with little or no commercial gain to be had. The FDA’s introduction of the Unique Device Identification (UDI) system aimed to improve patient safety and track affected devices in the event of a recall, but it remains costly and complex to implement. Legislation impacting the medical device industry is always poised to expand across Europe and around the world, adding to ongoing complexity of running a global operation.
Beyond the regulatory challenges that exist, market dynamics are ever changing. Emerging economies have seen huge growth, but that growth comes with risks for foreign companies looking to capitalize. Regulatory environments often favor local device companies and foreign entities have found partnering with local firms for sales and distribution to be a potentially risky move. The threat is very real that companies will copy their devices, capture their treasured intellectual property, and become direct competitors.
Amid these challenges, however, there is great opportunity and technological innovation will play a large role. From X-ray tubes to pacemakers to complex imaging equipment, the medical device industry has always embraced innovation with the goal of improving and saving lives. Advances in additive manufacturing or 3D printing will continue. Unlike traditional manufacturing, additive manufacturing does not remove material. Rather, 3D printing involves adding successive layers of material to form a 3D object. The potential for personalized medical devices, the creation of models for clinical trials, mass customization and even 3D printed human organs is extremely exciting.
While there is little doubt that the medical device industry faces an uncertain future and challenges abound, organizations will adapt, and advances in technology and manufacturing will play a role in the transformation. Managing all the change with a solution like QAD ERP can be the one constant in a sea of change.