Guest Column | September 2, 2016

Capitalizing On Surgical Oncology's Device Innovation Opportunities

By Harshal Shah, Cambridge Consultants

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Surgery is a crucial part of cancer treatment, as well as one of the most complex elements to address in the quest to achieve a cure for cancer. Surgical oncology is slowly changing, moving into multiple stages of cancer care. Considering the direction of cutting-edge medtech innovations, I think surgical oncology will see a wave of innovation in areas specifically focused on non-invasive preventive and diagnostic screenings, accuracy of tumor excision, and smart implants.

In the last few years, innovation leaders have made significant progress in terms of minimally invasive robotic surgery. It is rapidly becoming mainstay for some of the common and relatively low-risk surgical procedures, due to the advantages it offers for rapid postoperative recovery. Success in this area, along with the mature infrastructure that supports remote system integration and connectivity, has fueled talk at some leading oncology centers about the excellence of remote and robot-assisted surgery — and the previously unthinkable opportunities these technologies can open to make cancer care available in a totally different delivery model. 

While all of this will become a reality someday – in the next 20 years, according to general opinion – as far as cancer surgery is concerned, there are some critical milestones to be achieved before a roadmap to the next generation of surgical oncology can be prepared.

This article, focused on the opportunities in surgical oncology, is the third in a four-part series exploring the role of medtech innovation as it pertains to the distinct stages of cancer care: diagnosis, treatment, remission and recovery, and palliative care. Let’s first examine the role of surgery in each stage.

Cancer prevention – The most common example of a preventive surgical procedure is the removal of pre-cancerous polyps from the colorectal lining, performed to prevent the possibility of such benign polyps converting into malignant tumors in the future. A number of other preventive surgeries exist for other cancer types, too, such as melanoma and sarcoma.

Cancer diagnosis — The most common surgical intervention at the diagnosis stage is to extract a tumorous tissue sample for accurate diagnosis and the staging of cancer progression. Complexities vary depending upon cancer types and tissue growth location. 

Cancer treatment — The excision of cancer tumors is considered the most challenging aspect of surgical care in cancer. More specifically, the challenge is accurate estimation of tumor margin to prevent reoccurrence and eliminate the need for further surgery.  Generally speaking, for solid tumor cancer types, the prognosis is largely dependent on the success of this surgery.

Post-treatment — With cure rates improving due to advanced cancer care, post-treatment surgery is becoming increasingly common, and patient expectations of restored physical functioning and appearance are much greater. In the case of breast cancer, restorative surgery is quite common. However, new focus areas include restorative surgery for oral cancer, aided by implants, as well as functional restorative surgery for patients with soft tissue sarcomas in the legs, hands, and other ligaments.

Palliative care – In some advance-stage cancers, multiple tumor debulking surgery is performed with non-curative intent to reduce or manage overall symptoms and side effects of cancer. The introduction of implants, such as pain pumps, is another common surgical procedure used at this stage of cancer care.

Since surgical procedures are such an important aspect of cancer care at every stage, the key question is how innovation can make a difference in improving access, accuracy, outcome, and speed of such surgical procedures. If we are to achieve the ultimate vision of robotic or robot-assisted remote surgical procedures in order to provide more accurate, less invasive procedures and standardized outcomes, there are a number of areas where technology innovation can accelerate progress toward realizing surgery’s maximum potential in managing cancer:

Non-invasive, preventive screening – Fear and the trauma of being in the operating theater for a minimally invasive screening procedure, like a colonoscopy, is considered one of the biggest reasons why some high-risk patients go undetected until it’s too late. The situation is similar for ovarian cancer. Factor in the cost and time of such screening procedures, and it makes them a less-than-ideal tool to effectively detect cancer at an early stage. The vast opportunity here is to develop a technology that can accurately detect signs and symptoms of external cancers through non-invasive procedures – ideally becoming as simple as taking a chest X-ray. 

CT scans, contrast X-rays, color dopplers – all have been used in this direction to identify signs of unusual tissue growth. However, all of them are highly inaccurate in detecting small tissue growths.

Most of these technologies were developed for a different purpose. There is a need for a ground-up approach to design and develop a platform that suits the need for preventive and diagnostic cancer screening.  To put it simply – using poetic license – the ever-expanding periodic table is full of radiological elements that are yet to be tried for medical imaging and radiological use. At some point, we are bound to find an element with unique atomic and electromagnetic properties that we can leverage to yield better screening results than current imaging and radiological technologies – and, possibly, with less-harmful side effects.

Targeted radiation therapy – Radiation can effectively kill cancer cells. However, the very well-known challenge is to limit exposure of healthy tissues to radiation to avoid excessive damage. While gamma rays and laser beams are used for the same intent, so far success is quite dependent on very specific locations, sizes, and types of tumor.

The opportunity for innovation in this area is to design and develop a device or an implant that can really guide the emitting source to make a closed-loop system for effective control of the exposure area. Portability, form factor, and the cost of these radio-surgery devices are factors that limit their widespread use – and areas where technology and innovation can provide answers.

Real-time tumor margin – Considered to be the holy grail of achievable advances in cancer care, enabling real-time feedback of tumor margin during surgery also is one of the most daunting challenges in need of resolution. This area currently receives the most attention in surgical oncology innovation. While significant progress has been made, technologies developed so far are less-than-ideal solutions; any viable innovation that would illuminate or highlight cancer cells in real time during surgery would instantly set a gold standard.

Smart implants – With improving cure rates and progression-free survival rates, the need for restorative surgery also is increasing. Implants are obviously going to be an important part of such restorative surgery. Customizable, flexible, and controllable implants that can be adjusted through the different stages of disease and body transformation present throughout the treatment — especially in cases of facial, hand, leg, and spinal restorations — can help patients lead near-normal lives with minimal physical and psychological impact through the treatment.

Virtual platform for surgical training – Surgery, to an extent, is considered an art.  Leaders in their respective fields have their own unique methodologies, techniques, and practices. While their thinking is shared with the larger community of surgeons through publications and industry events, real-life interaction probably is limited to a few select residents who get to train under those practice leaders. But, what if every surgery, and every movement of the scalpel during that surgery, could be accurately captured? Using sensors and recording with micro cameras, healthcare providers could create a database that could support a virtual training platform for other practitioners.

While this sounds like wishful thinking, with no immediate and apparent benefit, the fact is that some of the most complex and effective surgery takes place behind closed doors, in just a few operating theaters and in the presence of a select few physicians in training. This inaccessibility likely limits the rapid evolution of gold standards in surgical oncology.

There are a host of challenges in implementing anything even remotely similar to this vision. However, until we develop a shared database of such complex surgical procedures, we may never inch closer to the futuristic vision of remotely controlled robotic surgeries. After all, we need meaningful information to feed into those machines before they can start delivering meaningful performance, be it in a hospital or a remote clinic.

Surgical oncology is going through a fast-paced evolution – partly due to innovations in other fields, such as diagnostics and cancer drugs research, and partly due to innovation of its own. While there are number of other areas where technological and engineering innovations could help improve therapeutic outcomes, I believe there are select areas (highlighted in this article) where innovations have the potential for maximum impact in cancer care. As a result, these therapies offer maximum untapped commercial potential, as well, making them attractive business ventures, from an ROI standpoint.  

About The Author

Harshal Shah joined Cambridge Consultants in 2015 as head of oncology drug delivery, focused on growing the company’s drug delivery business in the U.S. — in particular, expanding its offerings in the oncology space. With more than eight years of strategy and management consulting experience in pharmaceuticals, biotech, and drug-device combination products, Harshal has a deep knowledge and understanding of drug delivery device design, development, and commercialization. His past experience includes working with Bristol-Myers Squibb, Johnson & Johnson, and PRTM Management Consultants, and managing his own practice as principal of Labyrintheus Consulting.