Much like partnering with a reliable laboratory goods supplier, staying abreast of innovation trends in medical devices is necessary for laboratories seeking to stay at the forefront of the industry. In keeping with the industry’s expectations, 2019 saw the continuation and escalation of a number of innovation trends, including the proliferation of sensors in implantable devices, the rising crisis of device cybersecurity, and increased collaboration between firms in the medical device space. Each of these trends is expected to continue through at least 2025, meaning that the most advanced medical device companies will need to adapt to the emerging innovation environment promptly if they want to remain competitive--and, in some cases, remain in business at all.
Unlike in the 1990s and 2000s, the innovation trends for medical devices in 2019 and 2020 are not fundamentally linked to the development of innovative new technologies which provide value to patients by treating their illnesses directly. Instead, the trends to watch for the coming year are based around harvesting, exploiting, and protecting the data which medical devices produce and around making the most of the industry’s increasing levels of specialization. Thus, understanding each of these trends and their impact on every segment of the industry will ensure that device manufacturers and researchers can make strategic decisions wisely.
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More Sensors, More Data, and Higher Standards for Post-Market Data Gathering
Sensors are critical components of many medical devices, and thanks to advances in miniaturization, microfluidics, and computerization, medical devices are packed with more sensors than ever before. Throughout the economy, the price of the average sensor has dropped twofold from 2006 to 2016, and by 2020 the cost of each sensor is expected to drop by up to an additional 20%. While sensors used in medical devices are not experiencing falling costs as rapidly as general-use sensors like those used in industrial applications, they will continue to get cheaper for the foreseeable future.
Sensors are valuable in medical devices because they provide clinicians and manufacturers with information about how the device is performing in comparison to what the patient needs to address their medical issue. As the number of sensors per device grows and the cost of each sensor falls, the amount of data produced by the average medical device will continue to multiply, potentially exponentially so. Clinicians may not be prepared to fully process all of this data, but most device manufacturers are -- and that means that regulators are keen to hold them to a higher standard as a result.
Obeying the new standards put forth by regulators will require a new set of norms surrounding the handling of data in the R&D environment. Whether or not device manufacturers are ready to integrate their new datastreams into innovations in their products, laboratories will need to take careful stewardship of the growing body of information, especially when that information is derived from implanted devices in living patients. While data stewardship is not yet recognized as a canonical element of good laboratory practices, if the current trend of sensor proliferation continues, it may well become such an element.
- Cybersecure Devices by Design
With the volume of data being produced by medical devices exploding, it’s no surprise that many people have raised the alarm regarding the cybersecurity of the devices. Especially with implanted medical devices which are essential for the life of the patient, like pacemakers, cybersecurity may literally be a matter of life and death. As a result, device manufacturers and laboratories are taking steps to design and implement cybersecure devices which can’t be compromised even in the face of a determined adversary.
To their credit, much of the clamor surrounding the cybersecurity of medical devices stems from aggressive new regulations from the FDA which mandate preemptive cyber protection regimens for medical devices. Nonetheless, cybersecurity is likely to be an issue of increasing importance rather than decreasing importance in the coming years. To date, no major American-produced medical devices have been compromised by a cyberattack in a way which harmed patients -- but the smattering of large-scale breaches elsewhere in the medical sector indicate that it is likely only a matter of time. Effective medical device manufacturers will need to work with their clinical groups, suppliers, industry collaborators, and research staff to ensure that the entire spectrum of vulnerabilities is addressed comprehensively and that potential breaches are prevented decisively.
- R&D Collaborations Rising
Manufacturing and development collaborations have long been the norm between companies within the medical device industry, but in recent years, strategic agreements have made research-phase collaborations more common than ever before. 80% of surveyed executives within the medical device industry agreed that partnerships would be more relevant than in-house innovation for the future of new device development, and 82% stated that their companies were adopting new collaborations with suppliers as well as customers.
In other words, rising R&D expenditures in the industry are fueling innovation, but unlike in prior eras, that innovation is not siloed in the intellectual property holdings of individual device manufacturers or suppliers. Collaborations are growing for three main reasons:
- More effective specialization within companies
- Lowering the single-firm risks of taking gambles on innovative device concepts
- Increasing the speed of a project’s movement through the development pipeline
While each of these reasons would be cause for collaboration independently of the others, the conflux of all three means that manufacturers are heavily incentivized to make partnerships wherever they can. This is especially true for small and medium-sized laboratories, who may excel in specific areas but require outside assistance to scale their output or utilize research and manufacturing techniques that aren’t in their wheelhouse. For these laboratories, the first collaboration priority should be to secure reliable supplies, as without a single-source supplier the cost of procuring basic ingredients will be significantly higher.
Medical Device Innovation Trends to Watch In 2020
In 2020, the same innovation trends from 2019 will continue to be extremely relevant for device manufacturers and research laboratories in the medical device space. In particular, laboratories should continue to expect increasing levels of scrutiny from regulators regarding their cybersecurity practices, with new regulations regimes forming in markets outside the US and EU. Consequently, companies may find that resisting the trend of integrating more sensors into their medical devices can help to offset some of the rising regulatory burdens for data stewardship.
Regardless of data strategy, laboratories and companies seeking to strengthen their strategic position in light of these trends will benefit from partnering with a sophisticated equipment and reagent supplier. With the right supplier, companies can connect to the highest quality resources at an affordable price while also getting the support they need to keep their data secure and to forge strong partnerships with other companies in the industry.
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