Website | Contact | Back


Shawn McGuan
LifeModeler Founder CEO CTO


From the Founder
-> Health Care Revolution: Challenges and Opportunities
The medical device industry has been rocked with an unprecedented set of challenges centered about the pending US National Health Care Plan.  This daunting uncertainty as well as the looming changes in regulatory and clinical study requirements, unclear reimbursement schedules, etc., forms a dynamic landscape where two central themes emerge: the need for manufacturers to significantly reduce cost and the need for better efficacy of treatment therapies for patients. 

With the most challenging times, come the most promising opportunities.  Now, more than ever, there is a need in the medical device industry to lower costs by changing the paradigm of medical device design, testing and manufacturing.  Since the baby boomer customer is more demanding, innovation must be accelerated.  How can innovation be increased while reducing cost?

 

 

 

The old design paradigm
 It wasn’t too long ago that medical devices were developed using a “build and break” principal.  This principal is compounded by the fact that the mechanical testing was required via expensive and time-consuming cadaver tests.   With a 4-6 month turnaround for an engineer to get simple “go or no go” data from the test, together with the regulatory challenges, the innovation in new medical device designs were mostly just derivatives of predicate designs.

Enter the revolution
With the availability of new computational modeling tools, during the same period that a physical prototype was created and tested on a cadaver, literally millions of virtual tests can now be performed.  With the deluge of information from the  virtual test model, medical device engineers no longer think in terms of “A to B” comparisons with simple queries, they are looking at statistical variances and couplings between the mechanics of the device, the variance of the patience and the effects of surgical mal-alignment.  All at the same time!

Engineers get smarter
With this great capacity to explore countless “what if” scenarios, with instantaneous feedback, medical device engineers get smarter.  In other words, they develop an intuition of cause and effect between medical device characteristics, surgical position and patient disease state.  It is truly a holistic understanding of very complicated concepts and relationships.

Doctors get smarter too
With this proven effectiveness as a knowledge builder, computational modeling tools are now making their way to the surgeon.   This is now becoming a necessity since with all the new innovations in medical devices there will be a call for an escalation in surgical skill.  With more options available to the surgeon, the challenge becomes selecting the proper device and treatment protocol.  It also requires the skill set of the surgeon to be continually updated.  With more functional devices available, more knowledge of the surgical outcome must be available before the procedure is committed to.

In a sense, the computational modeling tools that the engineer used to design the medical device must be reconfigured into a “flight simulator” for surgeons.  The surgical simulator would have access to virtual mechanical models of instrumentation and medical devices as well as a musculoskeletal model of the patient in the diseased state.   The simulator would provide instantaneous feedback to the surgeon about the specific treatment protocol and its consequences on the functionality of the patient.  By exploring numerous strategies, the physician is fully prepared for the specific challenges presented by the patient.


Figure 1. A flight simulator for pilots (left) and a surgical simulator for surgeons (right).

What are you going to do to me, Doctor?
Surgery is a very stressful situation for any patient.  There is the thought of pain, long recovery times, as well as the unknown.  With the current standard of care, surgeons inform the orthopedic patient of the treatment strategy via plastic models, diagrams and video tapes.  The computer savvy baby-boomer patients are now demanding more information.  More information eases the fear of the unknown. 

This presents another opportunity for the biomechanics community; patient education.  With computational modeling taking a prominent role in medical device design and soon in surgical simulation; wouldn’t it be a good idea to play a role in reducing the fear of the patient? What if the patient could see a detailed computer model of his/herself in the diseased state, watch the surgeon implement the surgical therapy, then view the change in function and capability after the surgery? Can I play golf again? Can I do my gardening again?  How about walking up stairs? 



Figure 2. The Continuum. Computational modeling can have a huge impact on the making of the medical device, the surgery and, ultimately, the patient..

 

 

 

 

Opportunities, Opportunities, Opportunities
Never before has the medical device industry been under such pressure to reduce costs and at the same time increase innovation.  In order to fill this tall order, old methods must be updated with new methods and thinking presenting many exciting opportunities for the biomechanics and engineering communities all over the world.  We at LifeModeler are both proud and thrilled to be part of this evolution, the evolution of innovation and science that, ultimately, will enrich the lives of eventually, all of us.

GO BACK ->

Computational Modeling of Ardipithecus Ramidus: A Revolution in Evolution
The discovery of the 4.4 million year old Ardipithecus Ramidus (Ardi) was termed the “Most Significant Scientific Breakthrough” by the Journal of Science in 2009. The scientific effort t involved 15 years of research, 47 scientists and 9 nations and represented one of the largest collaborative efforts of its kind. LifeModeler is proud to be one of these scientific organizations, providing significant evidence to the mobility and social behavior of this fascinating creature. This ground-breaking work was featured on the Discovery Channel special “Discovering Ardi” in December 2009.

SEE THE DISCOVERY CHANNEL BROADCAST->


LifeMOD and the San Diego Padres.
See the ground-breaking work performed by our partner, Scripps Clinic in San Diego, in studying shoulder injuries for the San Diego Padres baseball team. Surgeons use LifeMOD to understand the mechanics of the particular patient’s shoulder injury before the operation.  They then “operate” virtually on the LifeMOD model before the surgery.  With this knowledge, surgeons have a very specific plan before surgery greatly improving surgical outcomes.

SEE THE NBC TELEVISION BROADCAST->




LifeMOD and Digital Orthopedic Surgery

The paradigm has changed.  With nearly a decade of success, medical device manufacturers have now institutionalized computational modeling into the design environment.  With powerful tools such as LifeMOD/KneeSIM and LifeMOD/SpineSIM, engineers are now able to consider literally millions of design variations in the same time it took to consider one physical experiment.   With this capability, engineers not only consider the impact of geometry, but the relationship between surgical placement errors and patient variations.  All at the same time! 

In working very closely with medical device manufacturers over the past eight years, we have seen the level of knowledge of the musculoskeletal-device system increase exponentially.  It has increased to the point, where engineers are able to predict the ramifications of surgical error, or patient disease states, just by looking at a drawing of a new medical device!


Figure 1. LifeMOD/KneePRO. A surgical simulator for total knee replacements.


Figure 2. LifeMOD/SpinePRO. A surgical simulator for spine surgeons

With this obvious increase in knowledge base in the medical device engineers, the scientists at LifeModeler began considering how this explosion of knowledge can directly affect the wellbeing of the patient.  We started looking at the other half of the equation: the surgeon.  After discussions with many leading orthopedic surgeons, it became clear that there existed an unmet need in orthopedic surgery: to evaluate the musculoskeletal-device system from a functional level before entering the OR.

Working with our medical device, surgeon and hospital partners we developed a tool which is now in the clinical evaluation stage for both knee and spinal surgeries.  These new exciting tools, LifeMOD/KneePRO and LifeMOD/SpinePRO, bring all the power and benefits of accurate, musculoskeletal simulation to the surgeon, in a surgeon-friendly format.  We have created a flight simulator for surgeons.

Now, in the matter of several minutes, the surgeon can review the procedure on an Ipad, before entering the OR.  Since the digital patient is based on scan and clinical data, the musculoskeletal model is personalized for the particular patient and disease state.  The surgeon positions the implant or spinal instrumentation, all the while, considering tissue balancing in the weight-bearing state of the patient. 

Since KneePRO and SpinePRO are both based on the industry-leading product development tools, KneeSIM and SpineSIM, the core technology is extremely rigorous and robust.  These products are currently under clinical evaluation by several high-volume orthopedic surgeons, several medical device companies and several hospitals.  Plans are being formulated to determine the regulatory pathway necessary to deploy the products in the hospital setting.  We will have more detail on this as it progresses.


Figure 3. The LifeMOD/SpinePRO process begins by importing a segmented and digitized scan of a particular patient or by selecting a disease condition from a library.


Figure 4. Data for scoliotic patient is imported into LifeMOD/SpinePRO


Figure 6. Instrumentation is specified.


Figure 7. Instrumentation is placed on the model, and rotated to correct the condition


Figure 8. Dynamic trialing is performed to examine the effects of the instrumentation, including examining the flexion/extension, lateral bending and axial rotation


Figure 9. The dynamic outcome is predicted including examining adjacent loadings of the functional spinal units, the range of motion and the bone/screw loading profiles.

GO BACK ->

 




Shawn McGuan wins the Excellence in Entrepreneurship Award from the Orange County Busniess Journal
At then ninth annual Excellence in Entrepreneurship Awards the Orange County Business Journal and the Ernst & Young accounting frim honored Shawn McGuan of LifeModeler, Inc. in San Clemente.

See Acceptance Speech->

See Television Interview->




New Developments in LifeMOD/KneeSIM

 “I have worked in the area of total knee design since 1970. This the most remarkable tool for the evaluation of knee designs that I have ever seen. The scope of the activities and parameters you have studied would take years to perform on test machines, and here you have produced it in one piece of software.”
Peter Walker 
Research Professor, Department of Orthopaedic Surgery, New York University School of Medicine
LifeMOD/

KneeSIM 2008.1

  1. GeBod Database Sizing
    In this latest version, KneeSIM is now equipped with a scaled sizing option based on the GeBod anthropometric database used in LifeMOD. There are now options for male/female and small/medium/large anthropometric sizing. The male medium is the orginal KneeSIM size.
  1. New Test Protocol
    KneeSIM 2008.1.0 also features a new Chair Sit/Rise simulation. It begins with a standing subject sitting down on a chair and then rising to a standing position again. It is similar to the other test protocols except that the knee flexion angle input is replaced by one on the hip and there is an added bumper on the machine below the hip slider that replicates the chair's function of supporting the upper body during the seated phase.

GO BACK ->



LifeModeler celebrates its 10th year in business!
The staff at LifeModeler wishes to extend a heartfelt “Thank You” to all our customers and supporters.   We have always held ourselves to the highest level of discipline, ethical standards, and professionalism and you, our valued customers and supporters, have returned your appreciation with continued loyalty.  As we move forward, we can promise you the same level of commitment and dedication which defines LifeModeler as a true pioneer in the exciting field of human simulation!

 

 

 

 

 



If you would like further information on our software and services, please contact us.