TEAM OSSIO
This three-month project was the main assignment for my ME110: Introduction to Product Development course at UC Berkeley. As a team of six mechanical engineerings, we worked in collaboration with Ossio Integrative Orthopedics, a start-up company that is focused primarily on the development of bio-absorbable orthopedic implants. Our mission was to reinvigorate the spinal fusion surgery process by utilizing Ossio's bio-compatible material.
OSSIO
Ossio develops and commercializes bio-absorbable orthopedic implant devices in order to eliminate removal surgeries, minimize implant complications, and prevent bone damage. The company's products can greatly improve the distribution of stresses in orthopedic implants to protect patients and heal bones. Ossio's website can be found here.
The company representative for our project was Rinat Friedman, Product Specialist.
Why is this important?
SPINAL FUSION SURGERY: PERVASIVE AND COMPLICATED
The number of spinal fusion procedures grows with each year, with an estimate of 2.5 milion procedures per year by 2020. Adjacent Segment Disease is a major drawback of spinal fusion surgeries, and often requires a return surgery within 5 years. This disease occurs when the metal spinal cage applies immense stress on surrounding spinal tissues.
INITIAL MISSION STATEMENT
By combining a deep understanding of these disadvantages as well as obstacles that doctors and surgeons face in the spinal surgery market, we sought to develop a new concept for the next-generation spinal cage implant made of Ossio material.
Sketches for deeper understanding of the components that are implanted during spinal fusion surgery: spinal cage, screws, and rods.
The User Needs Affinity is a mapping of our top user needs to categories that we felt encompassed the overarching problems that users (specifically patients) encountered.
Concept sketches for atypical solutions that would uniquely use Ossio material.
This venn diagram is a Reframing of our problem statement from a patient's perspective to a doctor's perspective.
The patient journey roadmap represents the decisions and scenarios that a prototypical spinal fusion surgery candidate would experience. It lists the situations that would occur before, during, and after the procedure. Alternative solutions, such as noninvasive solutions and simply ignoring the problem, are also considered.
This initial draft of our Value Proposition Canvas helps us detail the existing pains of our customers and the gains that we can provide them.
INITIAL DESIGN PROCESS
Seeking to test our creativity, my team and I brainstormed new ways to reinvent the spinal fusion process altogether. We conducted user interviews with spinal surgery patients and people with chronic back pain to obtain their feedback about the current procedure. Using this information, we developed our top User Needs and generated over 100 Design Concepts to explore novel methods of implementing Ossio's material. We used different Frameworks, such as Clustering and Reframing, to tackle different perspectives regarding spinal fusion surgery. At this stage, we had difficulties scheduling interviews with medical professionals, but recognized that such insight was paramount to improving our project proposal.
Dr. Gordon Tang, MD
“It doesn’t just depend on the cage itself, all the various tools used to deploy the cage are very important. These tools can make it hard or easy to deploy.”
IMPROVING OUR PROJECT PROPOSAL
New Mission Statement. Design Roadmap. Business Model Canvas. Concept Selection.
Further into our project timeline, we were able to communicate with biomedical researchers and spinal surgeons. One interview of particular interest was with Dr. Gordon Tang, MD, who graciously provided valuable input and perspectives into the spinal surgery industry. He brought up the issue of drastic change and the training difficulties that implementing new materials (such as Ossio) would create. From these interviews, we were able to fully reframe our project proposal and mission statement to fully address the needs of both patients and doctors.
Our new Mission Statement involved around focusing on a specific and significant portion of the spinal fusion surgery process and improving that by integrating with Ossio's bio-compatible material.
With a finalized Mission Statement, we shifted gears to creating a roadmapping canvas that integrated our user experience and design elements along a feasible timeline for us to finalize our deliverables. We also detailed a business model canvas to explore the intertwined relationships that we expected Ossio to develop when pushing their product into the market. Finally, we proceeded to the concept generation and concept selection phases, which would allow us to segue into the prototyping portion of our Design Process.
BUSINESS MODEL CANVAS
The business model and relationships that we envision Ossio will encounter.
DESIGN ROADMAP
Connecting core user needs to design features and technology needed.
CLUSTERING
Upon improving our original concepts and brainstorming more, we were able to classify our concepts in different clusters/product types.
REFRAMING BY TOP 5 USER NEEDS
We then decided if the concepts met our Top 5 User Needs:
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Eliminate long-term harms
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Maintain safety of procedure
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Shorten recovery time
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Shorten surgery time
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Reduce cost of procedure
CONCEPT SELECTION
After the User Needs screening, we utilized multi-voting methods to narrow down to three concepts:
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Ossio pedicle screw
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Injectable putty spinal cage
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Ossio material as bone graft
LOW FIDELITY PROTOTYPES
INJECTABLE PUTTY METHOD
This prototype represents a syringe used to inject Ossio material directly into the spinal region to form the spinal cage. We believe this concept is minimally invasive and quicker than the current procedure. However, it is too drastic of a procedural change and is thus less feasible.
PEDICLE SCREW WITH OSSIO MATERIAL
This prototype mimics a typical pedicle screw. Since Ossio material becomes bone within two years, implementing this product into spinal fusion surgery would be seamless. It would eliminate any need for removal procedures. However, having a new pedicle screw may involve a steep learning curve for surgeons, different equipment handling, and a large change to the surgery procedure.
OSSIO MATERIAL AS SUPPORT STRUCTURE
This prototype represents a spinal cage (all components connected) around a vertebra. This method decreases surgery time, recovery time, and risk factors because extracting bone graft from the hip would be obsolete. There is no change to the metal components of the spinal cage itself.
Ossio Material as Bone Graft
FINAL PROTOTYPE
We have reached the final prototype. We expanded upon our concept of using Ossio material as support structure (specifically bone graft) because we found it provided the most ability to address our user needs while also minimizing the impacts it would cause to changing the procedure as a whole. We were motivated to choose this concept because of the potential harms of extracting hip bone: risk of chronic pain at site, higher chance of infections, nerve injury, bleeding in harvested area, and limited amount of bone in iliac crest for elderly patients.
The images below show our CAD renderings and physical prototype. The blue putty represents Ossio material. An additional image is added as reference for a spinal cage implant.
ACKNOWLEDGMENTS
Rinat Friedman
One of the major lessons we have learned is that the product development process is iterative and varies widely in scale. Throughout the semester, our ideas and methods were constantly changing. Rinat and Ossio were very receptive to the new ideas we had, and this allowed us to explore our creativity in order to assist Ossio to the best of our abilities.
Euiyoung Kim, Danielle Poreh
Within the scope of our project and the course, it was evident that we were given a particularly complex and intense task to redesign the spinal fusion implant/surgery. The organization of the class, however, allowed us to achieve this goal in an effective and efficient manner. Following the step-by-step design thinking process from interviews to roadmapping to concept generation provoked us to not get caught up in the overall difficult project statement. Professor Kim and Graduate Student Instructor Danielle were entirely supportive and understanding towards our struggles. They helped us work around the obstacles we faced throughout the semester, and we were ultimately successful in achieving our mission.
Nate Barrett-Wilsdon, Katie Decker, Trier Mortlock, Sunjit Singh, Nisha Subramanian
As majority third-year mechanical engineering students, my team and I were initially highly unfamiliar with the topic of spinal fusion surgery and spinal cages. With diligence and thorough research, we were able to work effectively in learning about this process and industry. Also, due to confidentiality reasons, we were unable to retrieve Ossio material or learn about its functional and material properties. Upon narrowing down our concept selections, we made different assumptions of the material properties and used these assumptions to our advantage in the design thinking process. In general, our actions throughout working on the project allowed us to gain further insight on the design process as a whole. Additionally, we actively communicated and supported each other, and we achieved our team goals effectively and efficiently. It was a privilege to work with these intelligent and selfless individuals.