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12 June 2015
Supporting Innovation &
Guiding Early Commercialization
Vaishali Kamat
Head of Digital Health
INS, Montreal
12 June 2015 2
WHO AM I?
12 June 2015 3
More than 50 years experience
12 June 2015 4
A global product & technology development firm
NEW DELHI
TOKYO
SINGAPORE
CAMBRIDGE
BOSTON
12 June 2015 5
SUPPORTING
INNOVATION
12 June 2015 6
Life saving therapy
Mary suffers from chronic back pain…
… which dominates every minute
of her life …
12 June 2015 7
Lifestyle therapy
Anne suffers from frequent,
crippling migraines…
…she also has 3 energetic children
12 June 2015 8
New indications
Essential Tremor
Parkinson’s
Dystonia
OCD
Depression
Tinnitus
Epilepsy
Stroke
Pain
Epilepsy
Parkinson’s
Alzheimer’s
Respiratory support
Chronic pain
Malignant pain
Spasticity
ALS
Huntington’s
Obesity
Gastroparesis
Irritable Bowel Syndrome
Profound deafness
Headaches
TBI
Epilepsy
Depression
Chronic pain
Chronic pain
Angina pain
PVD pain
Incontinence
Pelvic pain
Sexual dysfunction
12 June 2015 9
Today’s systems are obsolete for new indications
12 June 2015 10
The vision
12 June 2015 11
The 5 year vision – less invasive implantation
Tool Sensing
Embedded tool-tip nerve prox-
imity sensing provides informa-
tion for targeting the optimum
implant position and for avoid-
ing damage to other nerves and
critical structures.
Ergonomic Tool
The handtool is small and precise. A
triangular section allows for comfortable
handling in multiple orientations
Neurostimulator implant
Implant is housed in the tool
blade. It also has on board
sensors
12 June 2015 12
The 15+ year vision – A simple outpatient procedure
12 June 2015 13
The Ecosystem
12 June 2015 14
Wider Solutions
Disease
management
Preventive
care, lifestyle
management
Data analytics
& decision
support
CARE COORDINATION
12 June 2015 15
PATH
TO
COMMERCIALIZATION
12 June 2015 16
Not business as usual
12 June 2015 17
Be Bold. Think platform
12 June 2015 18
Reimbursement may not be the be-all, end-all
12 June 2015 19
Think partnership
12 June 2015 20
We specialize in delivering “World’s firsts…”
12 June 2015
Cambridge UK
Registered No. 1036296 England
Cambridge Consultants is part of the Altran group, a global leader
in Innovation. www.Altran.com
www.CambridgeConsultants.com
Boston USA Singapore

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Supporting innovation & guiding early commercialization

  • 1. 12 June 2015 Supporting Innovation & Guiding Early Commercialization Vaishali Kamat Head of Digital Health INS, Montreal
  • 2. 12 June 2015 2 WHO AM I?
  • 3. 12 June 2015 3 More than 50 years experience
  • 4. 12 June 2015 4 A global product & technology development firm NEW DELHI TOKYO SINGAPORE CAMBRIDGE BOSTON
  • 5. 12 June 2015 5 SUPPORTING INNOVATION
  • 6. 12 June 2015 6 Life saving therapy Mary suffers from chronic back pain… … which dominates every minute of her life …
  • 7. 12 June 2015 7 Lifestyle therapy Anne suffers from frequent, crippling migraines… …she also has 3 energetic children
  • 8. 12 June 2015 8 New indications Essential Tremor Parkinson’s Dystonia OCD Depression Tinnitus Epilepsy Stroke Pain Epilepsy Parkinson’s Alzheimer’s Respiratory support Chronic pain Malignant pain Spasticity ALS Huntington’s Obesity Gastroparesis Irritable Bowel Syndrome Profound deafness Headaches TBI Epilepsy Depression Chronic pain Chronic pain Angina pain PVD pain Incontinence Pelvic pain Sexual dysfunction
  • 9. 12 June 2015 9 Today’s systems are obsolete for new indications
  • 10. 12 June 2015 10 The vision
  • 11. 12 June 2015 11 The 5 year vision – less invasive implantation Tool Sensing Embedded tool-tip nerve prox- imity sensing provides informa- tion for targeting the optimum implant position and for avoid- ing damage to other nerves and critical structures. Ergonomic Tool The handtool is small and precise. A triangular section allows for comfortable handling in multiple orientations Neurostimulator implant Implant is housed in the tool blade. It also has on board sensors
  • 12. 12 June 2015 12 The 15+ year vision – A simple outpatient procedure
  • 13. 12 June 2015 13 The Ecosystem
  • 14. 12 June 2015 14 Wider Solutions Disease management Preventive care, lifestyle management Data analytics & decision support CARE COORDINATION
  • 15. 12 June 2015 15 PATH TO COMMERCIALIZATION
  • 16. 12 June 2015 16 Not business as usual
  • 17. 12 June 2015 17 Be Bold. Think platform
  • 18. 12 June 2015 18 Reimbursement may not be the be-all, end-all
  • 19. 12 June 2015 19 Think partnership
  • 20. 12 June 2015 20 We specialize in delivering “World’s firsts…”
  • 21. 12 June 2015 Cambridge UK Registered No. 1036296 England Cambridge Consultants is part of the Altran group, a global leader in Innovation. www.Altran.com www.CambridgeConsultants.com Boston USA Singapore

Editor's Notes

  1. I lead the Digital Health business for Cambridge Consultants, a product and technology development firm. I have over 15 years experience in the development of various medical devices and in the past 5 years, have been focusing on helping clients conceive and develop connected devices and solutions to better engage with users and improve health outcomes.
  2. Cambridge Consultants help clients deliver breakthrough innovation in several industry sectors such as healthcare, consumer and wireless. Our work spans a huge range of skill sets from ASIC development for a leadless pacing device for EBR systems, a California start up to compelling products for the world’s largest sports companies. We have worked in wireless technologies for more than a couple of decades. The world’s first single chip Bluetooth solution that led to the formation of Cambridge Silicon Radio (CSR) which has the largest market share for Bluetooth chipsets – is our spin out company. http://www.cambridgeconsultants.com/core-skills
  3. I work with a talented bunch of engineers, scientists & designers who are based around the world and serve our global client base. http://www.cambridgeconsultants.com/about-us/innovative-product-development
  4. Innovation means different things to different people. A lot has been said about disruptive and radical innovation – I think of innovation as doing things differently, enabling what was previously not feasible. I believe the entire healthcare industry is desperate for innovation – and not just in technology. Yes, healthcare lags behind several other sectors when it comes to application of simple technology that we now take for granted. But besides that, there is ample scope and a dire need for innovation in the way care is delivered. We need to change the role of the patients – think of them as individuals or consumers. Neuromodulation is still a relatively new therapy whose potential has not been fully exploited yet. There is significant potential to do things differently and offer therapies that break the mould of the traditional implant. Some thoughts on how we think this might be achieved follow. http://www.cambridgeconsultants.com/projects/neuromodulation-device-development?source=3761
  5. Take Mary - today, she is the typical neuromodulation patient. She is offered this therapy as her last resort after suffering for years experimenting with different medications. Mary and people like her have been the target market to-date for neuromodulation companies, but we believe this might change in the future. http://www.cambridgeconsultants.com/media/resource-library/literature-request?fid=38664&nid=5838
  6. Tomorrow, the target user is likely to be someone like Anne… who is young, in the prime of her life. But she does have a condition that disrupts her life. She could use neuromodulation therapy which could save her from losing a couple days of each month despite taking heavy medication doses. However, she is not likely to go under the knife to have this therapy and her insurance certainly won’t pay $30,000 for an implant when medications can help her. She needs a low cost, simple device and therapy solution that can take the place of medications. Neuromodulation can become a front line therapy for several chronic conditions that affect lifestyle, but are not life threatening. The growth potential in this market is huge, but only if there is a radical change in the products and solutions being offered.
  7. There is a lot we still don’t know about neural pathways and there is some way to go before neuromodulation becomes a front line therapy, but there is a lot of research on going in this field. Several potential applications have already identified - many of these affect people’s lifestyle. The target users will be for “normal” people, not necessarily patients. To address these individuals, a mind shift is required along with a whole lot of other changes to the way we approach the space.
  8. If Neuromodulation is to become a viable front line therapy for chronic conditions, we need to think “outside the can”. But it’s not all about the technology. A completely different commercial value proposition will be required – one that is more amenable to lifestyle enhancing therapies rather life sustaining ones. No more big, ‘place and forget’ implants. A much more interactive solution will be required that can provide control in the hands of the user, gather evidence of efficacy and close the loop between the various stakeholders in the healthcare system.
  9. The need for targeted stimulation in various parts of the body will necessitate smaller implants that can be placed in-situ. Technology advancements are making miniaturized electronics feasible. Wireless communications and power transfer capability means the battery and other smarts can be pulled out of the body into a wearable device, which can allow the implant to become very small.
  10. The implant procedure can be simplified and the risk reduced by making it a minimally invasive procedure. This will also enable it to be carried out at a larger swathe of clinical facilities rather than just at large speciality hospitals. Smarter delivery tools like this concept (http://www.cambridgeconsultants.com/media/press-releases/new-surgical-experience-2) developed by Cambridge Consultants can aid the procedure via sensors at the tip of the instrument to guide location and provide precision control for placement. Procedure specific implants can therefore be made feasible. Eliminating the need for a complex surgery can also take away the fear amongst users making them more amenable to consider this therapy.
  11. Eventually, as technology advances even further and nano scale electronics become available, implants could be the size of a grain of rice enabling delivery via an injection – no surgery required!! This could then enable Neuromodulation to be offered via the doctor’s office or an outpatient visit.
  12. But it is not all about the device. In order to make this therapy suitable for management of lifestyle conditions and rounding off our vision of putting control in the hands of users – a complete ecosystem will be required. Using consumer platforms such as smart phones, it will be feasible to gather data, engage with the users, and perhaps even offer services. Additional sensors and devices can be used to gather supporting data about user wellbeing, effectiveness of the therapy etc. This will of course dictate infrastructure needs – data management, security, analytics, etc. all become necessary. But these are already being set up in other sectors and even in healthcare. There is ample opportunity to leverage these tools. Moreover, once a platform is established, it can help sustain different therapies.
  13. In addition, we need to think about services that can be offered not just to the users but to the other stakeholders as well. Payers will play a significant role as always and with pressures on payments mounting, there may be a need to gather evidence of outcome improvement in order to secure and retain reimbursement. Services that bring value to individual stakeholders can also provide an alternative and highly lucrative recurring revenue stream.
  14. The path to commercialization will be different in tomorrow’s environment – especially as an ecosystem based low cost high volume device becomes available. It will not be business as usual. With the consumer in charge, expectations will be different. What they want from a system, how they choose the solution will be different and thus will dictate different a approach to sales. Today, surgeons are the primary call point but the new stakeholders may be making buying decisions tomorrow.
  15. Traditionally medical device companies have focused on efficacy of their device and rightfully so. But in the world we live in today, that is not enough. In a highly competitive market, it is easy to imagine that several devices will be equally effective. Why then would the user choose a particular device? Price wars is not the answer. One must think about differentiation? What value does your solution bring to the user? How will you engage the user and make a difference to their life. Is your solution sufficiently targeting the unmet needs? Medical device companies need to learn from the consumer companies – they know very well how to attract and retain consumers. A good example of this is in the orthopeadic industry whose products were just metal and plastic. Soon they became commodity and companies struggled to retain market share as more options became available, because there was no differentiation. Now they are beginning to reinvent themselves and are thinking about additional tools and services to help consumers manage or deal with the condition e.g. rehabilitation services, wearables for monitoring healing & recovery, etc. These services are aimed at better outcomes and improving lifestyle of the end user – it provides a direct means to engage with the user as well as differentiation to the company.
  16. Medical companies have always relied on reimbursement as their source of revenue. But when you offer ecosystem based solutions, there is a whole new revenue model out there that deserves consideration – SERVICE based recurring business. The device selling price may not matter any more – if you make a minimally invasive solution that is not a specialist surgical procedure, the device can be low cost and the money can come from the service. You may even be able to make the numbers stack up without needing to secure reimbursement – yes, it is unthinkable right now but there is precedent of consumers paying for convenience and good value service. Think of consumer pull vs. the traditional medical push. Take Diabetes for example. Glucose meter manufacturers relied on strip sales as their primary source of revenue. They were happy to give the meters away. However, as soon as CMS significantly reduced reimbursement for test strips, these companies were badly hit. Now they have begun to think wider – offering disease management solutions as potentially new revenue generators. http://www.cambridgeconsultants.com/projects/diabetes-care-product-development?source=3761 That said, if you are able to improve outcomes and lower the overall cost of care with an integrated solution, payers are going to be interested anyway.
  17. Typical path to market for the start ups has traditionally been acquisition by one of the big companies. Large established companies develop their own product and bring it to market themselves. In tomorrow’s brave new world, other avenues will need attention. Entire ecosystems cannot and need not be built by medical device companies. You can rely on partners, even from outside the healthcare field to provide complimentary skills and building blocks to pull the solution together. Large companies are making equity investments rather than early acquisitions – they are relying on innovation happening faster outside their four walls. Pharmaceutical companies are interested in supplementing their drug portfolios with devices and diagnostics that can help provide complete all around therapy. We are seeing several non-traditional companies entering healthcare and making big investments. Who knew Google would be interested in contact lenses or Apple would hire MedTech heavy weights? And what about the recent partnership between IBM, J&J, Apple and others – these companies plan to leverage each others strengths as well as data to extract greater value and potentially provide new solutions. The world is changing! It’s time to do things differently.