Introduction to BMD Concepts
Traditionally surgeons have been intimately involved with innovations in orthopedics; however, over the last two decades most surgeons seem content to go to meetings simply to learn new surgical techniques. In the orthopedic world, a particular eco- system appears to have evolved where the industry, with their ability to hire gifted engineers, innovates infusing technology into various aspects of orthopedics. The academia appears to have abdicated its leadership role, and is content to simply validate what is proposed by the medical device industry. The masses (orthopedic surgeons) in general appear to have given up on asking tough questions on behalf of themselves and their patients. Orthopedic surgeons quibble about the fact that the industry appears to be disconnected with their needs, however, few speak up.
A simplistic view of orthopedic surgeon’s role is as follows: 1. Soft tissue preparation 2. Bone preparation 3. Application of force (prosthesis to bone) and (prosthesis to prosthesis) 4. Assessment of the effect of force.
Item 1 on the list has an artisanal component to it in that soft tissue surgery has to be learned more as art than science and can only be acquired through apprenticeship. However, items 2,3, and 4 have nothing to do necessarily with skill and talent of the surgeon. Our contention is that bone preparation, application of force, and assessment of the effect of force, which collectively institute the majority the orthopedic procedure are all extremely primitive. Over the last thirty years nothing has changed in this arena. We still use a mallet to impart force, which is no different than a rock. We still use our own human senses (auditory, tactile and visual) to assess the quality of fixation, which is susceptible to our emotions and our physical strength, and we still use tools similar to those in our kitchens and garages to prepare bone.
As an example, the industry has pushed surgical techniques that focus on more complicated soft tissue surgeries (item 1). Examples include the “Two incision Technique” and “Minimally Invasive Surgery”. These procedures were promoted without providing additional tools to make surgery more reliable. Hundreds of millions of dollars were spend training surgeons without ever producing good results for the industry or the patients.
On the other hand, most of the infusion of technology has gone into product development understandably so because the industry is focused on profits and it is much easier to monetize a product than tools. However, at this point we have reached the end of the innovation S curve with commoditization of products. Most prostheses are similar with little differentiation.
Our ideas are generated from the front lines of orthopedics from the surgeon’s perspective. Why can we not have better tools that modernize and standardize orthopedics? Technological application and assessment of force and bone preparation (items 2,3, and 4) can dramatically enhance the surgeon’s ability to perform error free operations.
Our primary intent is to make the surgeries safer for our patients, and to improve function, while minimizing the odds of doing harm. Nonetheless there are secondary benefits that can be garnered for surgeons and society in general. Many surgeons feel tremendous stress doing certain operations such as total hip replacement since it is fraught with risk and uncertainty, particularly during the application of the prosthesis to bone. These operations can become less risky for surgeons, producing fewer complications, reducing the need for revision surgery, and ultimately hugely benefit insurance companies and the government who are forced to burden the costs.
These operations can be dramatically improved. However, the enhancements will not be found in better biomaterials and designs but rather in the process. We believe the white space in orthopedics, and the primary method of providing differentiation in joint replacement surgery today, is found by focusing on basic engineering and analog technology (not digital or data); all too frequently ignored. These ideas we have proposed can be part of the resources of a successful future for companies with the foresight to see the next S curve.
Finally, we understand that there is a large focus in orthopedics on biologics, however, in the foreseeable future joint replacement is here to stay and as long as we are doing these procedures we can make them more reliable.
We have proposed five basic ideas to change the world of orthopedics:
- The application of force (the cause) can be modernized and standardized. The assessment of force (the effect) can be modernized and standardized. This new model of technological force application and assessment is first established for application of prosthesis to bone.
- Bone is an elaborate spring like structure with viscoelastic properties that can be further exploited to our advantage for press fit technology. We can fine tune bone with more sophisticated tools for a better press fit, eliminating the need for screws, bone cement and uncertainty.
- Technological application/assessment of force in item 1 applies equally as well to application of prosthesis to prosthesis. We have proven this concept with working prototypes: How to obtain a cold weld to eliminate Trunionnosis.
- Alteration of the crystalline structure of metal for a specific functional purpose. Particularly with use of vibratory force for prosthesis insertion, we contemplated prosthesis and implants that “want to insert” with less force. We also contemplated prosthesis that more closely resemble the actual intricacies of bone at the microstructure and mesoscale levels based on stress distribution, to eliminate corrosion with prosthesis to prosthesis bonding and bone resorption and stress shielding in prosthesis to bone bonding.
- A novel method of fracture fixation and stabilization is proposed for the trauma patient, contemplating use of robotics and anisotropic metals. We believe this technique could supplant the use of plates and rods and eliminate long and difficult surgeries with excessive dissection, blood loss, use of traction, and radiation.
Our goal is to make the orthopedic operations safer for patients and less risky for surgeons. We believe many of the failures in orthopedics are associated with the lack of good tools with which to perform surgeries. As an industry we may not be providing the right analysis, nor reporting on the failures associated with lack of proper tools. It is time to change that. We are looking to industry, academia, private and government support to advance these concepts. Many of the ideas proposed have been significantly de-risked and prototyped. There are several white papers that need academic involvement to become landmark papers. We have three issued patents and over two dozen applications pending examination.