Mark Greener talks to Cambridge Consultants’ Commercial Director and Head of Digital Health about the challenges of commercialising innovation
Thomas Edison wasn’t just a superlative inventor – his 1,093 US patents include motion picture cameras, incandescent lightbulbs and an alkaline storage battery – he also pioneered the industrial research laboratory as well as modern product development and commercialisation. Indeed, Edison formed more than 300 companies worldwide to manufacture and market his inventions. His ability to commercialise his inventions is one reason why Edison is iconic. But the shelves of patent offices groan under the weight of brilliant ideas that never realised their true potential for want of effective, efficient commercialisation.
Over the last few years, medical device companies have been forced by markets and investors to raise their commercialisation game. Commercialisation, however, often remains a challenge, especially given the constant changes in the marketplace. Against this background, Vaishali Kamat, Commercial Director and Head of Digital Health at Cambridge Consultants, says she regards clearly defined value propositions and benefits as essential for device companies to succeed in this fiercely competitive, highly regulated and dizzyingly dynamic market.
Teenagers fixated, to the exclusion of all else, on the latest Freemium game may seem a long way from a patient using a device to deliver a drug for chronic obstructive pulmonary disease (COPD) or logging changes in glycaemic control. Kamat suggests device companies can actually learn valuable lessons from the consumer digital sector. ‘We live in a wireless world, so interconnectivity, engagement and usability are very important in any medical device offering,’ she comments.
‘We’ve used learnings, drivers and trends from the consumer market to understand consumer preferences that we can apply to medical devices. After all, patients and healthcare professionals are still consumers,’ Kamat continues. In other words, patients and professionals have certain expectations, often forged in the consumer market, that influence how they view the design, usability and features of a medical device.
The proliferation of apps recording weight, exercise and blood glucose levels, and increasing delivery of general education about diseases and treatments through social media channels reinforces the point. ‘There is a general acceptance of these channels among consumers,’ Kamat remarks. ‘However, the pharmaceutical and biotech sector has not yet realised the potential on offer by apps to, for instance, influence outcomes and adherence.’
Nevertheless, the device market is tightly regulated, which, Kamat admits, can slow innovation and commercialisation of digitally enabled technologies. ‘The regulators are starting to recognise the value of digital solutions and wireless medical devices,’ she says. ‘Little will happen unless we can break the reimbursement mould and there is payment for digital solutions. This is already happening. We have seen a change in the last two or three years.’
The medical device market in the USA was worth more than an estimated $140 billion in 2015, equivalent to about 45 per cent of the global market, according to the US Government Accountability Office. So, inevitably perhaps, much of the impetus behind this sea change comes from the other side of the Atlantic. ‘The USA medical system, in common with other countries, faces unprecedented pressure on healthcare budgets and there is a growing focus on cost containment. In the last year or so, purchasers in the USA have required companies to demonstrate benefits or improved outcomes and we’ve seen similar trends elsewhere in the world. Increasingly effective commercialisation means demonstrating value.’
In other words, innovative technology no longer guarantees successful commercialisation of a medical device. ‘If you can demonstrate that a device improves outcomes, you are likely to see rapid adoption,’ Kamat points out. Fortunately, digital health allows companies to collect large amounts of data that can help demonstrate their worth to cost-sensitive and often critical customers.
For example, analysis of big data sets could allow a company to demonstrate that a new drug delivery device improves compliance, clinical outcomes and healthcare utilisation. ‘Big data analysis could yield digital biomarkers that allow health services to track the effectiveness of a device or therapy,’ Kamat comments. ‘We’ve seen advances towards digital biomarkers in the last year and it’s clear they represent a massive opportunity to aid commercialisation and improve outcomes. However, we’re a long way from realising the full potential as further clinical validation will be required.’
Meanwhile, increasingly sophisticated surgical and other interventional devices are entering the market. Kamat says that these often trace their origins not to industrial R&D, but to the surgical team in the operating room. ‘Surgical and other interventional devices are often responses to particular problems and, because they improve the procedure or reduce the risk, there is usually more acceptance of the innovation,’ she says. ‘Workflow is the big barrier to commercialisation of surgical and other interventional devices. If you can show that a new surgical or interventional device improves workflow without major changes, or improves efficiency without disturbing the current workflow, it’s likely to be accepted.’
Sometimes gradual evolution rather than revolution helps commercialisation. For example, the first insulin pump, developed in the early 1960s, was the size of a backpack. Now insulin pumps are about the size of a mobile phone and are clipped to a belt or carried inside a pocket. They release insulin in response to blood glucose levels in real time and, therefore, produce a more physiological glycaemic control than standard injections. These are now evolving into fully-fledged and digitally enabled artificial pancreases.
Such devices already collect data, use sophisticated algorithms and are relatively expensive with their use restricted to high-risk patients. Kamat argues that a technological advance and a relatively small incremental increase in price is more likely to be accepted in a small population that is already using a previous version of the technology than, for example, a revolution in inhaler design for every child with asthma or adult with COPD that dramatically increases costs. It is, of course, different if the company can prove equally dramatic improvements in outcome.
Analytical methods that once occupied a whole bench in a specialised laboratory now fit in the corner of a primary care office. Analyses that once needed highly trained technicians who understood every chemical nuance are now performed by a healthcare professional who may not have a clue how the ‘black box’ works. Indeed, advances in microfluidics, immunochemistry and processing power are bringing diagnostics closer to the patient and reducing costs. ‘The use of Point of Care diagnostics will undoubtedly increase, reflecting the marked improvements that technology offers,’ Kamat notes.
‘In addition, an increasing number of diseases require long-term monitoring to track the patient’s progress,’ Kamat says. ‘Ideally, some of this monitoring should be performed in the patient’s home rather than requiring a trip even to the local health centre.’ After all, patients with diabetes or asthma successfully self-monitor blood glucose and peak flow respectively. Increasing connectivity allows results to be uploaded into the patient’s records.
Unfortunately, the IT infrastructure could present a barrier to optimal commercialisation. ‘Patient records, back-end systems and other aspects of the IT architecture are not as well designed as they would be if we were starting from scratch,’ Kamat admits. ‘Several “flavours” of electronic medical records exist and they don’t allow data to be readily transferred between them. Today, each of the many companies involved in connected medical devices are picking their own back-end systems. We really need some harmonisation so that the collective data set can be fruitfully utilised.’
Despite this haphazard development, most companies recognise and are seeking to address the issue, which simplifies the commercialisation of the next generation of devices. Kamat welcomes, for example, recent initiatives to standardise file transfer protocols and telemetry. ‘There’s considerable fragmentation and it’s not yet clear who “owns” the patient’s data,’ she adds. ‘In the future, patients might own the data from the various providers. They won’t necessarily carry the data around on their smartphone. They may, however, be able to grant access via a portal.’
Despite a few clouds overhead, Kamat predicts a bright future for the device sector. ‘There’s a lot of uncertainty and various companies offering different solutions often to the same problem,’ she says. ‘But this underscores the sector’s potential. The changes in the USA are helping to drive a global focus on health outcomes and reducing the burden on hospitals that help device companies develop a business model and gain reimbursement. The next few years will inevitably see many changes and we will understand how the current trends play out. But the device sector has a lot of potential and I’m cautiously optimistic.’
Fundamentally, commercialisation means thinking about the customers as much as the technology. ‘I advise clients to clearly define their value proposition and state who benefits: is it the patients, the clinicians or the payers?’ Kamat concludes. ‘No matter how clever the technology is, if you can’t demonstrate who benefits and how, it’s probably not worth developing and commercialising the device.’
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