A new white paper outlines methods that companies can use to conduct studies and set guidelines that could eventually shape standards of care and reimbursement for additively-manufactured products.
The white paper, published by SME’s Medical Additive Manufacturing/3D Printing Workgroup, is meant to prompt dialogue about how clinical and economic evidence is collected and then distributed. As orthopaedic companies invest millions in additive manufacturing, the workgroup is right to ask that industry demonstrate through data: What for?
I participated, alongside device companies, scientists and clinicians, in the workgroup session that laid the foundation for the white paper. Nearly two days were spent discussing which methods and tools should be used to develop adequate evidence for anatomical models, cutting guides and custom implants. This yielded recommendations on priority populations, comparators, outcomes, assessment methods, study design and further priorities, all outlined within the white paper.
For example, the group decided that patient-matched surgical cutting guide outcomes for joint replacement should include “operating room efficiency, accuracy from plan to surgery, functional scores, patient satisfaction, rehab time and infection rates. Additional considerations included the importance of American Academy of Orthopaedic Surgeons guidelines, and avoidance of 90-day complaints.”
I’ll leave the complete details for your reading of the white paper. And I encourage you to read it. Anyone interested in additive manufacturing would benefit from a pure understanding of orthopaedics’ position at the basic level of generating evidence for the technology. Orthopaedics faces global demands by payors, providers and patients for greater clinical and economic data. The white paper’s authors, which include heads at 3D Systems, Johnson & Johnson and Materialise, write that the dialogue must continue and collaboration is needed from those with influence and expertise in setting guidelines and indexing data — potentially, the American Academy of Orthopaedic Surgeons and the National Institute of Health 3D Print Exchange.
In providing background on the topic, the authors summed up the situation well: “Without clear guidelines on how economic studies and clinical trials should be designed and conducted, and without a clear assessment of endpoints that need to be investigated, there is risk of inappropriate use and misallocation of limited resources for medical 3D printing.”