Value-Based Robotics - Micromate blog

Read this two-part blog post in full at MicroMate's website:

Robotics in Healthcare: the breakthroughs

"The idea of robotic surgery was initially developed for the military to enable surgeons to operate on wounded soldiers from a remote and safe location.

They first entered the civilian operating room two decades ago, in 1999, for urology, gynecology, and bariatric surgeries and the first years have been focused on establishing the validity of robotics and the first steps of market introduction through early-adopting institutions.

Upon the establishment and acceptance of robotics, surgeons, and hospitals needed to redesign their ORs and ways of working to get the best out of robotics, instead of just replacing minimally invasive or open-surgical techniques with robots. As efficiencies come into action and technology itself evolves, robotic design, specificities, and use for cardiothoracic, general, head and neck, orthopedic and spine, neurological, and pediatric surgery are now a reality.^[3] 

Robotics in Healthcare: the barriers

Despite having an increasing market value and attractiveness, being one of the key trends on healthcare for the 2020-2030 decade and the subject of significantly large investments (both with respect to R&D and M&A events), robotics and their benefits are only provided for a few selected indications in a limited number of fields of application.

Twenty years into the development of the robotic surgery market, approximately 10% of procedures in the USA are being done robotically and globally that number drops to 2% ^2,3. Until adoption rates of robotics are high across all fields and geographies and its benefit are established, the VBHC principles are not met. This raises the question: What are the main barriers to establishing Value-Based Robotics as a reality?

A major study developed by Ipsos has tried to list what are the barriers to increasing the use of robotics in surgeries. The results have ranked the biggest hurdles are associated with practicality and cost. The key five aspects in consideration are ⁴:

• Too much physical space is required: the currently available robots-on-wheels solutions, often employing modified anthropomorphic arms that are commonly used in industry, end up having a size and weight which contrasts with the need for minimal invasiveness. Hospitals are required to perform modifications to its infrastructure and the OR itself, as well as changing clinical workflows, as the surgeon’s access to the surgical field is physically restricted.

• High initial and running costs of the required equipment: equipment costs (the cost of the robot itself ranges from 300.000€ to 1.500.000€), running costs (disposables costing thousands of euros per procedure) and infrastructure and resource costs (specialized operating rooms, trained and experienced staff and special non-standard procedures) are often prohibitively high. This means that robots tend to be focused on centers of excellence or university hospitals with financial capacity to fund the investment.

• High levels of training required: hospitals are often required to invest significant sums to train their staff for weeks to have an accredited center, as well as paying monthly fees to manufacturers to have clinical support specialists attending surgeries to technically support the procedure. This creates a high dependency, both from robotic companies and from the internally trained staff itself.

• Lack of adequate government reimbursement: due in part to a lack of convincing clinical evidence (see next point), this limits the uptake of robotic solutions. Limited out-of-pocked affordability means suitable patients or payers choose other more affordable, reimbursed methods. In the US and South Korea, robotics is covered by private insurers under “minimally invasive” codes, but it increases the insurance premiums for everyone. Where reimbursement exists, the challenge is that the healthcare reimbursement system is outdated, as it has not caught up with improvements in patient recovery (patients are forced to stay in the hospital for several days to be reimbursed, despite robotics already being used in surgeries in ambulatory and outpatient settings) and coding has not caught up with the new robotic indications (some procedures that are more often performed now thanks to robotics do not have a code, or the reimbursement does not match the value given by robotics). Finally, most of the existing robots are released only for specific indications and, even if the technology can be adapted to support more than one application, in more than one medical specialty, they cannot be used because of these regulatory constraints.

• Insufficient evidence on clinical benefits to justify investment: for most of the indications, there is not enough clinical evidence of significantly superior outcomes, compared to conventional methods to justify the vastly increased costs (twice as expensive, or more, per procedure). The published literature gives mixed evidence, either establishing a significant equivalence in terms of outcomes, or showing improvements in some specific outcomes when compared to standard surgical methods. There is even evidence of poorer clinical outcomes in cancer interventions where the surgeons are not fully qualified to perform the procedures. This forces most decision-makers to look for cost-offsetting arguments to justify the investment in robotics, facing again challenges with the high initial and running cost challenges.

Interventional Systems tackles this challenge by offering a miniature robot with all the key features that make it the perfect smart assistant for image-guided procedures, Micromate™, while at the same time decreasing the need for high initial and running costs.

These are key points in our goal to make medical robotics the standard of care instead of the exception. Something that seems impossible, until it is not.

Better clinical outcomes

We are on the cusp of the minimally invasive surgery era, where higher accuracies and faster recovery times allow for less time spent in inpatient care.

High accuracy is crucial in image-guided interventions. Inaccuracies, low diagnostic yield, and incorrect initial treatments make for repeated interventions and increasing costs, posing logistic and personal burdens for the clinic and the patient while subjecting all parties involved to further unnecessary radiation.

When compared to the state-of-the-art:

• • More accurate: published studies demonstrate that Micromate™ is 50% more accurate than state-of-the-art techniques^1,2,3 (patient-mounted or freehand needle guidance solutions) for percutaneous image-guided procedures, often achieving average accuracies within 1mm along the trajectory and the planned target position. This gives physicians increased confidence that their surgical plan will be successfully executed, especially for procedures that require the placement of multiple (and often perfectly parallel) needles.
  • Lower complication rates: an average of around 4% of complication rates on stereotactic surgeries using Micromate™ have been described^4,5,6, corresponding to a reduction of complication rates of up to 43%, compared with the state-of-the-art⁷.
  • As minimal as minimally invasive can be: Micromate™ provides a universal needle-guide set for percutaneous procedures and, fueled by its high accuracy, smaller incisions for stereotactic procedures can be achieved⁴.
  • Lower radiation exposure: a physician’s exposure to radiation can be reduced by virtually up to 100%, as Micromate™ can be remotely controlled from outside the intervention room under live imaging. As for the patient, a radiation decrease of up to 84% has been documented, mostly due to the faster alignment speed, when compared to free-hand alignment techniques^2,8. 

A truly enabling technology

Clinical evidence shows Micromate’s irrefutable advantages in terms of accuracy, invasiveness, and radiation exposure.

But patient-centric care also requires physicians to resort to three other dimensions of their skillset: technical skills (to align instruments to the surgical plan and maintain that alignment), and intellectual and clinical skills (to treat the patient and make intra-operative decisions that may impact the therapy).

We have designed Micromate™ to take over the technical skills, by performing highly accurate movements and maintaining a working channel for instrument insertion and guidance.

Due to its small form, Micromate™ fits inside the gantry or between a patient and the C-arm detector, which allows the alignment to be executed under live imaging. Potential deviations are corrected live and immediately.

This frees physicians to focus on doing what they do best: treat the patient. This means not only defining the surgical plan, evaluating its condition, and looking out for complications, but especially manually delivering the instrument.

Despite autonomous instrument insertion being a very recent trend for percutaneous procedures, physicians still rely on haptic feedback while delivering instruments. It is even possible to differentiate between different tissues during instrument insertion, based on the tissue’s resistance – for example, this is used to detect when a biopsy needle enters a tumor.

Micromate™’s disposable needle guides have been designed to hold instruments with a user-adjustable gripping force, allowing to find an optimal compromise between play-free guidance while keeping the much-needed haptic feeling.

Finally, the instrument can be inserted under live imaging as well, which brings additional, real-time information to help physicians deliver the instruments to the desired target location.

Micromate is not meant to replace the physician, it’s meant to enable their skills while providing assistance (as a stable third hand) on the most difficult step of the workflow, without requiring significant adaptations."

Source: MicroMate