See photo explanation below.

See photo explanation below.

I reacted with excitement to the FDA’s recent announcement that $38 million had been granted to the Clinical Trials Transformation Initiative (CTTI) to increase the quality and efficiency of clinical trials.  CTTI is based out of Duke University and includes nearly every major government healthcare agency, pharmaceutical company and trade group as members, as well as several medical device manufacturers and academic medical centers.

It’s encouraging to see that the FDA is investing in initiatives that can be paradigm changing in clinical trials. I believe that software-based image analytics can be a key component in this strategy. By leveraging the power of software analytics in clinical trials, where the protocols are well-defined and carefully executed, software-based quantitative measurements of the images provide a cost-effective and objective enhancement to traditional medical image observers. We believe that this initiative is a signal that objective, quantitative analytics in clinical research will become an industry standard in FDA data acceptance. Image analytics techniques may be among the most advanced to deliver that data.

ImageIQ has seen a rise in acceptance of consistent, objective, quantifiable data in the clinical trial sector via software-based image processing and analysis, as well as its effectiveness in reducing costs and accelerating research timelines. For example, in orthopedic spine flexion-extension assessments, we’ve seen variability in measurements of simple angles of up to +/-10%. That level of subjectivity and variability in the measurements resulted in a larger cohort size than necessary to power the study, which resulted in increased costs and trial length. That situation, in the worst case scenario, could lead to less accurate data and weaker product efficacy claims, which undoubtedly causes problem in FDA clearances and eventually post-market acceptance.

There are groups planning their clinical trials that don’t even realize that imaging and software-based image processing and analysis can be a powerful alternative to supporting and strengthening their product safety and efficacy claims. We are very pleased that the FDA has recognized the importance of alternatives to traditional methods that will provide objective, quantifiable and consistent data, sending a clear message to medical device and pharmaceutical companies that the bar has been raised when it comes to clinical trial data.

P.S. Photo description for our science fans:
Osseointegration of Resorbable ACL Screws
Project Summary: Bioresorbable interference screws are theorized to fill in with bone tissue over time as they dissolve, but still provide the same initial anchoring support for the ACL as traditional metal screws. Potentially, such an implant could delay/eliminate revisions related to loosening that is observed with metallic implants. To evaluate efficacy of a resorbable ACL screw, computed tomography (CT) scans were performed and subsequently analyzed to determine the rate of screw resorption, graft remodeling, and new bone formation in the tibial tunnel. In a cohort of 16 patients with multi-timepoint CT scans (post-op, 6 months, 1 year, 2 years), baseline volumes for each patient were reoriented such that the tibial tunnel was aligned perpendicular to the transverse axis. Subsequent timepoints were spatially co-registered to the baseline volume and the tibial tunnel was splined for each timepoint. Using custom tailored segmentation software, the screw, bone graft, and new bone was segmented for each tunnel and pseudocolored to provide a visual assessment of each component over time. Extracted quantitative measures included tunnel volume/diameter, graft volume/density, trabecular bone volume/density, and screw volume/density. For assessment of algorithm accuracy unimplanted screws were imaged on both clinical and micro-CT (high resolution standard) scanners (600 um vs 20 um resolution) and segmented using algorithms described above. Despite their drastically different resolutions there was only a 1% difference in analyzed volume between the clinical and preclinical scanners. Additionally, metal screws present in the femur of a number of patients were analyzed across multiple timepoints using the segmentation routines above. Even though voxel dimensions and scanning protocols were not consistently maintained across all timepoints, there was only a 4% variation in analyzed volume.

There are hundreds of similar images in the Capabilities section of our website. Browse around.


Hey, who’s the customer here?

customerservice-webToday’s blog is about a topic that seems to be increasingly rare in the business world — and that is customer service — with the actual CUSTOMER as the focal point.  It’s just the approach of making yourself easy to do business with and being a good client- facing company.

Recently, my daughter needed to have a letter sent from her dentist to her orthodontist. My wife called the orthodontist’s office to make an appointment and the orthodontist’s office said they had not yet received the referral letter, which is not surprising — sometimes that happens. But then we got to experience their “standard” of customer service at which point the person in the orthodontist’s office said, “Call me back when the letter arrives.” My wife was perplexed. Her thoughts: First of all – Huh?  How am I supposed to know when the letter arrives? And second of all — really? I’m the client here. I’m a patient and a client.

Conversely, I was recently taking my parents out for a round of golf and it fell upon me to make the tee time. I called a local golf course and a young lady answered the phone. Clearly, she’s not the owner of the course, she’s probably a summer intern. But when I called to make the reservation, their computers were down (they use a computerized tee time scheduling solution). She apologized, and with low expectations, I assumed I would be told that I could call back in a few minutes. But no, that’s not what happened. This young lady, obviously at the direction of management, well trained in customer service, said, “Sir, can I take your name and phone number down and I will call you when our computer system is back up. It will probably be 5 minutes, but I will give you a call.” How refreshing. How absolutely 100% refreshing that something as simple as calling the client back, instead of putting the burden back on me to call back. And obviously this golf course is aware that having that level of service — being in a competitive environment — that this is how you retain clients. What a nice experience. And sure enough, she called back and we had a wonderful round of golf.

Unfortunately, healthcare and all its related businesses are “Big Business,” and with that customer service can be poor, if not absent altogether. Why? It’s cultural, with leaders not only demanding it of their employees, but also investing in training and technology to ensure it happens, and setting the example that the customer comes above all else. All the time, not just when it’s convenient.

We strive to do that every day at ImageIQ, I think most of the time we get it right. We’re not perfect, and the times we don’t get it right, we try to make it right.

As leaders, we owe it to our customers to make their service common practice, not a treat. I would love to hear from medical device, pharmaceutical and biomedical CEO’s on how they make that happen. If you read this, please leave a comment below with your thoughts.