While some doctors seem quick to prescribe a pill for any number of healthcare concerns, there are numerous others who would prefer a more “exact” science in addressing a chronic disease, medical condition, or neurological disorder. The problem with a pharmaceutical is that it can react differently for different patients; one answer for a patient may not resolve the issue for another.
Unfortunately, the medtech sector has not been able to offer a device solution for all of these patients either. While implantable neuromodulation technologies are currently being indicated for a few conditions, there are many more for which they do not yet have a solution. As more research is done and a number of design challenges are overcome, this may change in the future.
With this in mind, I conducted the following interview with Vaishali Kamat, the head of digital health at Cambridge Consultants. She provided a number of insights on implantable neuromodulation devices, how they are used currently and where they could be beneficial, development challenges, and what’s ahead for the technology.
Sean Fenske: Thank you for speaking with me on neuromodulation technology. Before we begin, can you please tell me a little about Cambridge Consultants’ experience in the development of medical devices?
Vaishali Kamat: Cambridge Consultants has been developing medical devices for a variety of clients for several decades. Our experience spans a number of sectors — drug delivery devices for pharmaceutical clients to large, high-throughput diagnostic instruments to active implants to patient monitoring technologies. For the last five years, we have been developing digital health solutions, including medical devices that are wirelessly connected to smartphones or tablets, as well as mobile medical apps.
Fenske: What opportunities do you foresee for neuromodulation technologies in the healthcare space?
Kamat: Today, neuromodulation therapies have been approved for management of severe pain, treatment of movement disorders such as Parkinson’s disease and neurological conditions like epilepsy. Some gastric and pelvic disorders can also be managed via neuromodulation.
Ongoing research and trials are showing promise for use of neuromodulation therapies in heart failure patients, as well as for treating conditions like overactive bladder and depression. With improved technology and reduced cost, I see the opportunity for neuromodulation therapies to be offered earlier in the treatment regime and also become a viable treatment option for several other conditions, including chronic diseases like obesity.
Fenske: What design obstacles need to be addressed before these conditions can be treated with neuromodulation technologies?
Kamat: The primary challenge with today’s neuromodulation devices is that they are large and require a specialized invasive surgical procedure for implantation. This also makes the solution very expensive — as a result of which, neuromodulation therapy is prescribed after all other treatments have failed, including a variety of pharmaceuticals. This often means a long period of suffering for the patient before they receive effective treatment or relief.
In order to be suitable for a wider patient population, and especially in treatment of chronic diseases, the implant devices must be made much smaller such that the procedure can be simplified. Moreover, the cost of the technology needs to be brought down in order for it to be a viable commercial proposition.
The size of the implant is primarily driven by the battery that is intended to power the device for seven to ten years. Efficient methods for providing power from outside the body need to be developed and tested to eliminate the need for a large battery in the device, which can then allow device size to be dramatically reduced.
Moreover, for several lifestyle diseases, it would be beneficial to be able to put control of the therapy in the hands of the user or patient, rather than it being a “set and forget” kind of solution like it is today. Thus, wireless communication will be required with the implant for data gathering as well as to manage therapy settings.
Fenske: Do these technologies always have to be implanted? Is there another way to employ them without requiring them to be placed inside the body?
Kamat: Neuromodulation devices need to be implanted either permanently — or, in some applications temporarily — to gain access to the nerves they stimulate.
Fenske: With that being the case, what other challenges are involved with neuromodulation technologies beyond the issue of size?
Kamat: Today, most neuromodulation implants require surgical procedures for placement. Additionally, accurate placement of leads at the appropriate location to deliver the therapy requires a significant level of skill, especially in cases where the nerves are difficult to reach. Thus, the devices need to be designed to function and remain in the body for several years, requiring electronics and sizeable batteries enclosed in biocompatible, hermetically sealed cans (usually made of titanium).
Fenske: If successfully developed for large volumes, do you foresee neuromodulation technologies rivalling pharmaceutical solutions?
Kamat: Today, neuromodulation implants are considered as second- or third-line treatments, after all pharmaceutical options are exhausted. However, if implants become smaller and cheaper, and require less-invasive procedures for implantation, they could very well become an earlier and even better treatment option compared with pharmaceuticals for certain conditions as they can prevent side effects and complications that often arise from long-term use of drugs.
Fenske: Earlier, you mentioned the need to eliminate the large battery typically required with current neuromodulation technologies. How do you then propose to power these technologies?
Kamat: There is currently a lot of work being done to develop methods for wireless power transfer, which could be relevant to these implants. This can then enable devices to have a small rechargeable internal battery that can be charged periodically from outside the body.
Fenske: You also mentioned integrating the ability to “communicate” with these devices through some sort external device. How might this best be accomplished?
Kamat: Some implantable devices are already being equipped with wireless communication technology such that they can be monitored from outside the body using a handheld device. That trend will continue. Earlier generations of implants were equipped with magnetic-induction-based communication methods that enabled the physician to query the device or set parameters with the help of an external wand held close to the implant location for the duration of the data exchange.
Fenske: As I’m sure you’re well aware, incorporating that type of two-way communication capability opens up the issue of security. How would that best be addressed with these technologies?
Kamat: Security must be designed into the system, taking into account both the implantable as well as the external device. There are several methods to make the device secure, including encrypting the data transmissions and incorporating specific handshakes between the implant and the external device so that an unauthorized external device cannot connect with the implant. Authenticating the user of the external device is also important. Security measures can be implemented in both the hardware and software of the devices.
Fenske: What’s the next step in development? Where is the technology headed?
Kamat: There is significant research being done to understand neural pathways and the physiological response to various neuromodulation techniques. As this research continues to mature, new neuromodulation therapies will be devised for more conditions and clinical evidence will need to be gathered on their efficacy. In parallel, significant engineering effort will be required to make implants smaller using miniaturized electronics and more efficient powering techniques. Smarter delivery tools will also need to be developed to simplify the implant procedures.