Anatomics Calls for a Paradigm Shift.

Given the diversity of the human population it is clear that healthcare needs to be tailored to the individual and to their community. Healthcare professionals must deliver care by identifying the needs of the individual and their community and by responding with appropriate interventions. Dramatic improvements in ‘diagnostics’ are generating a huge amount of data that can be analyzed by healthcare professionals to assist with decision making, yet treatment options are often limited.

 Our traditional factory based manufacturing industry delivers a range of therapeutic drugs, devices and products. A clinician will traditionally select the appropriate ‘off the shelf’ devices and products to deliver treatment. The regulatory and reimbursement framework has been designed around this traditional model of healthcare.

In the last century surgeons like Homer Stryker invented devices and prosthetics that were of benefit to their patients and allowed them to work safely and efficiently. Many great ideas were patented and licensed. Manufacturing investment was made on the basis of clever patents that delivered better outcomes. This system of invention, patenting, manufacture and protected retail sales enabled multinational corporations to grow and prosper. However, now the cost and waste of this over regulated and over protected industry is spiraling out of control.

Our current healthcare model leaves surgeons powerless to make even the most simple change in the design of instruments, devices and prosthetics due to the suffocating regulatory red tape. When surgeons think of a better way help patients they are disempowered by the system to make any changes. As a result surgeons become disenchanted and uninterested.

The ‘mass manufacture’ of drugs, devices and products requires substantial investment by industry. The regulatory framework requires extensive evidence regarding ‘efficacy’ and ‘cost effectiveness’ to justify reimbursement. Even once approvals are granted investment in production, logistics, inventory and marketing can be prohibitive. Healthcare costs seem to constantly increase, partly due to unnecessary waste and inefficiency. Corporations investing heavily in highly regulated designs have little incentive or appetite for improvement on those that become commercial. The spiraling cost and diminishing efficacy of our healthcare system is an extraordinary failure of the traditional model of healthcare.

Personalised treatment options have exploded as a result of the dramatic increase in diagnostic information being made available. Now we can sequence a person’s genome and identify specific drugs that will be effective yet most people are still treated with ‘shotgun’ therapy that has a significant and wasteful failure and non compliance rate.

An understanding of the ‘normal distribution’ or the ‘bell curve’ that is characteristic of biological systems, such as healthcare, is fundamental. This bell curve can at best be segmented by traditional healthcare into a limited number of ‘mass produced and off the shelf’ options. Typically industry will ‘cut the tails’ off the curve to save on less popular sizes or options. People who fall between sizes or options will be pushed into the nearest segmentation. This approach allows industry to focus on the most cost effective range to remain profitable.

The validation of quality in mass manufacture is usually ‘up front’ and is typically associated with the rigorous regulatory framework. This makes sense as before industry is willing to invest in production, inventory, and marketing it requires a degree of certainty that the product will be reimbursed. It also makes sense for the regulatory authority to ensure safety early on if many thousands of people will live with the product for a lifetime. The current framework places almost the entire emphasis on ‘pre approval’ and mass manufacture.

Traditional 20th century manufactured off the shelf products need expensive and complicated logistic and inventory supply chains. Clever corporate marketing sustains the system with expensive proprietary ‘computer navigation systems’ and ‘surgical robots’ to carve patients to fit their mass produced 'off the shelf' parts. Junior surgeons are instructed by industry funded consultants to use complex proprietary technologies so that they can succeed in practice. This strategy has proven to increase cost and complexity without improvement in surgical outcomes.

Meanwhile in our 21st century, a revolution in digital design and additive manufacturing (AM) has created a ‘new economy’. AM or 3D printing, allows internal device architecture to be manufactured with infinite complexity and diversity. Such architecture enables the density and modulus of the device, biocompatibility of the device, and the shape of the device to be designed and manufactured from the finest materials just for your body. Disruptive additive manufacturing (AM), gene sequencing and real time online biomedical engineering has now completely changed the paradigm.

Personalised healthcare allows patient data to be used to manufacture patient specific drugs, devices and prosthetics using community based distributed manufacturing. The enormous amount of data that is now generated can be used to design patient specific interventions that can be manufactured with infinite specifications. Such devices, drugs and prosthetics can now be personalised to match the patient rather than having the patient conform to ‘off the shelf’ products. Without doubt specific therapies and devices will reduce cost and improve efficacy.

By analysing the ever increasing amount of morphometric data it is now possible to accurately define the individual by an ever smaller number of demographic and morphological characteristics. For example, by entering a number of variables such as age, gender, race, weight, height, blood group, bone density etc. an analytic algorithm can almost exactly predict the shape and size of the prosthesis that an individual may require. The bell curve is squeezed to fit the individual and with only minor human interaction and validation an ‘exact match’ can be identified and manufactured. One can now understand that this model reduces the requirements for wasteful inventory, logistics and marketing. Advanced additive manufacturing technologies can now enable distributed community based manufacturing. If products are patient specific waste and non compliance are virtually eliminated. Internet and cloud computing allows data collection and analysis to occur remotely.

With an intelligent manufacturing system patient data can be used to develop patient specific therapy. Each time iteration occurs through this process a new therapy is designed. The therapy can be validated and verified using computer simulation and artificial intelligence. A ‘process based quality system’ will measure each therapy and generate outcome data. This data can then be used to continuously feedback into the process to improve the next person’s therapy according to previous outcomes. Currently our therapies are based on a limited trial for a limited period of time. Not only is this methodology time consuming it is also wasteful. This methodology does not cater for individuals and lacks the ability of adaption to unexpected or changing outcomes. How can a trial be conducted for a patient specific device or therapy?    

Now hospitals and healthcare facilities can collect patient data and manufacture their own solutions at cost price. At the same time efficiency is improved and waste minimised. Employment opportunities are made within the community in manufacturing and service delivery. Communities are enabled to deliver the individualised healthcare solutions that culturally relevant.

The "FDA is responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need."

The FDA recognises that additive manufacturing (AM) is an established technology that holds a number of advantages over traditional manufacturing for certain device applications. In a FDA report (Technical Considerations for Additive Manufactured Devices: Draft Guidance for Industry and Food and Drug Administration Staff issued on May 10, 2016) it was noted that "AM has the advantage of facilitating the creation of anatomically-matched devices and surgical instrumentation by using a patient's own medical imaging. Another advantage is the ease in fabricating complex geometric structures, allowing the creation of engineered porous structures, tortuous internal channels, and internal support structures that would not be easily possible using traditional (non-additive) manufacturing approaches".

Despite the recognition that AM is a superior manufacturing technique for many medical devices, prosthetics and orthotics the FDA has done little to embrace the technology. The FDA needs to realise that a complete paradigm shift is required to truly regulate the 'quality and cost effectiveness' of medical devices and products in the future. The FDA needs to understand that superior devices can now be manufactured at the 'point of use' with an infinite number of specifications to best suite individual patients. The enormous risk inherent in our current ‘mass produced & off the shelf’ medical device industry is not applicable to patient specific manufacturing. A fault in the manufacture of a 'mass produced device' potentially affects thousands of patients over a period of many years, whereas a fault in a 'patient specific device' will only affect a single individual. Now patient specific designs can be continually improved by way of iteration in a quality process that is impossible with mass manufacture. Morphometric data constantly builds in an 'iterative patient specific design process' refining our understanding intelligently.

AnatomicsRx Pty Ltd has developed software architecture that enables surgeons to innovate and create devices, prosthetics and instruments in their own hospitals. AnatomicsRx technology is digitally disruptive and enables surgeons by interaction with biomedical engineers online, at any time, and from any country. Digital design, simulation and validation can be performed in real time to create surgeon designed and patient specific devices, prosthetics and instruments. Once a surgeon has approved a design, a device can be immediately manufactured in their own hospital by trained and certified staff within hours and to the highest quality standards.

The Anatomics ISO 13485 quality system applies to the entire process to manage risk for the surgeon, the hospital and the patient. Efficiencies created by this technology reduce inventory, logistics, and sterilisation costs while simultaneously reducing waste and errors. These savings are passed on to insurers, government, patients and the environment. Reimbursement revenue can now returned to local communities to sustain affordable healthcare and create jobs and opportunity.

A regulated ‘process’ can create reimbursable ‘devices’ using distributed community based manufacturing. The FDA can create a quality system that delivers affordable healthcare driven by innovation, jobs and value based outcomes.

The FDA can enable ‘Community Based Personalised Healthcare’ to engage the potential of surgeons, healthcare professionals, teachers and students to cohesively provide affordable high quality healthcare to all people.

The FDA must quickly recognise that their 'outdated 20th century regulatory framework' creates expense & inefficiency that stifles competition and maintains the status quo of profit hungry multinational corporations.

By regulating the ‘process’ and not the ‘device’ the FDA could create a quality system that delivers affordable healthcare driven by innovation and value based outcomes.

The FDA needs to enable ‘Community Based Personalised Healthcare’ to engage the potential of surgeons, healthcare professionals, teachers and students to cohesively provide affordable high quality healthcare to all people.