Intralign + OrthoIntelligence™

There are an estimated 6,500 medical device companies in the United States contributing to an industry that is expected to reach
a market size of 133 billion dollars by 20161. Innovation through new technologies is a primary driver for increasing healthcare expenditures and the current orthopaedic regulatory environment allows for companies to rapidly bring new products to market with limited evidence2. The FDA currently reviews over 4,000 pre-market notifications each year, adding to the immense number of medical devices already available3. Given the overwhelming number options; how should decisions to use a device or product be made, and what information is available to make these decisions?

MD | IQ Analytics

OrthoIntelligence™’s trademarked MD | IQ analytics manage the Big 4 cost-evidence scenarios by creating value in the intersection of their expansive database of evidence (OrthoEvidence™) and their Influencer Network (OrthoInfluencer™). The process evaluates products through marketing claims, differentiation through product comparison, key influencer opinion, and quality of evidence in available clinical data.


OrthoIntelligence™ provides interpretation of current marketing claims through a transparent ranking system of the evidence used to support the claims and an independent analysis of data. They rank evidence as platinum, gold, silver, or bronze based on the level and quality of evidence.



Using cost data against analytics OrthoIntelligence™ can provide product comparisons within a construct, evaluating if there are differences between manufacturers.

Differences Between Manufacturers: OrthoIntelligence™ provides a comparative assessment of products within a construct to identify if one manufacturer is superior to another, while also presenting the unit price for each product.

Product Comparison:

Influencer Opinion

OrthoInfluencer™ provides a rich network of insights from leaders, whether surgeons, administrators, allied care professionals or researchers segmented by content expertise, geography, and profiles (innovator, early adopters, late adopters, skeptics) within the area of interest.

What outcome is most important when considering using patient- specific instrumentation?

Improved implant survivorship appears to be the most important outcome for surgeons when making a decision to use patient- specific instrumentation.

Quality of Evidence: OrthoEvidence™

Using a growing database of more than 3,000 high quality A.C.E (Advanced Analysis of Clinical Evidence) reports OrthoIntelligence™ finds timely high-quality evidence that will drive market trends, indicating the effectiveness of treatments, and identifying areas where current needs are not being met.

Scenario: Patient-specific instrumentation in total knee arthroplasty has piqued surgeon interest, becoming a prominent topic of research in the past 3 years resulting in 13 high-quality research publications.

Quality of Evidence: High-quality evidence indicates that patient- specific instrumentation does not provide significant improvements in implant alignment or surgical outcomes (i.e. operative time, blood loss, intraoperative complications) compared to standard instrumentation. Further evaluations are needed to determine the effect of patient-specific instrumentation on implant survival. As recent high-quality evidence from rigorous clinical trials is disseminated, it is expected surgeon interest will align with evidence and opinions towards cost-effectiveness will decrease substantially, slowing the adoption of this technology.

Click here to visit the OrthoEvidence™ website.

OrthoIntelligence™ is powered by OrthoEvidence™

1) selectusa.commerce.gov/industry-snapshots/medical-device-industry-united-states
2) P T. 2008 Jun; 33(6): 348–359.Challenges in Evaluating and Standardizing Medical Devices in Health Care FacilitiesC. Lee Ventola, MS
3) www.fda.gov/NewsEvents/Testimony/ucm250709.htm