3 steps for quality leaders — Mark Eydman, Six Pillars Consulting interview

While it starts by an outstanding interaction, it is more likely to build over time, with a deepening relationship and multiple “touch points”.

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With rising marketing and new business costs, never has it been more important to retain happy customers.

But how do you know whether your customers are truly loyal? Whose role really is it to manage customer loyalty? And how do you know what actually helps you retain your customers year-after-year?

Below, Mark Eydman, MD or Six Pillars Consulting, shares his insights.

Customer satisfaction is not the same as loyalty

ISO 9001:2015 focuses on customer satisfaction:

  • Clause 4: Ensure the QMS consistently provides products and services that meet customer requirements and enhance customer satisfaction
  • Clause 6: Ensure quality objectives are relevant to enhance customer satisfaction
  • Clause 7: There are the resources available to enhance customer satisfaction

However, Mark Eydman, Founder and Managing Director of Six Pillars Consulting says loyalty is about much more than satisfaction.

Customers tend to feel satisfied, or dissatisfied, as a result of a specific interaction with an organisation. For example, a well laid out supermarket, well lit, clean and staffed by friendly assistants can drive that feeling.

Loyalty is so much more. While it starts by an outstanding interaction, it is more likely to build over time, with a deepening relationship and multiple “touch points”.

A loyal customer believes that their relationship with your organisation is in their best interests!

Satisfaction

ISO 9001:2015 doesn’t specify how to keep your customers loyal, so here are three steps to measure and improve customer loyalty.

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Solid Evidence That Attending Medical Devices Training Is Good for Your Career Development

These bodies also state the nature of the regulations and the requirements that medical device and healthcare organizations need to adhere to in order to meet their expectations.

Training is the foundation to producing products and services that meet regulatory and quality expectations and industrywide acceptance. This is generally true for all products and services, but in particular, for medical devices. Why? Medical devices are not in the same league as any other ordinary product that can be handled by anyone in any manner.

Training is the only means by which medical device companies that manufacture medical devices and the staff that handle these products on a daily basis and administer them on patients, can ensure patient safety. Training that imparts a degree of understanding of the methods, processes and technologies in this field is the means to this and to meeting the quality requirements.

Training ensures safety and quality in the manufacture and use of medical devices

Medical devices are highly specialized products that require extreme care and diligence when handling. A slight error or carelessness can result in far-reaching consequences that have the potential to cause anything from physical harm to death for the patient or the user. This explains the criticality of training for medical devices because an untrained person is more likely to cause errors in using these high-specialty products than a trained one.

Another core factor in medical device training is that it is part of regulatory expectations in most markets. Getting trained in the prescribed manner is very crucial for medical device professionals because training is indispensable in helping them meet regulatory requirements. The main purpose with which regulations are made is to ensure that the products that complying organizations produce and the processes they employ meet the required quality standards.

Since medical devices are an area in which one cannot take chances, regulatory agencies such as the FDA and the EMA, and standards bodies such as the ISO have made training mandatory for medical device professionals. These bodies also state the nature of the regulations and the requirements that medical device and healthcare organizations need to adhere to in order to meet their expectations.

Professionals and organizations that meet these standards are assured regulatory approval. They are also more likely to win public confidence for the quality of their products. Medical device training is what helps assure that stay updated in their professions.

Regulations mandate training in medical devices

The role of training in medical devices can be understood from the fact that it is not just another desirable, nice-to-have feature, but one that is made mandatory by regulations in this area. These are some of the regulations that make training for medical devices mandatory for companies in the medical devices field:

–       ISO 13485:2016 – Medical Device Quality Management System Requirements

–       ISO 14971

–       Medical Device Single Audit Program (MDSAP)

–       New Requirements set out by the EU Medical Device Regulation and In Vitro Diagnostics Regulations

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90% of visitors to EU domains grant GDPR consent

How the consent rates broke down at the granular levels, such as those who consented to Vendor X for ad targeting but not to Vendor Y for web tracking.

After all the teeth-gnashing, what if the vast majority of visitors give their consent for use of their personal data under General Data Privacy Regulation (GDPR) rules?

That appears to be what’s happening with the Quantcast Choice consent management platform, at least for European Union (EU) domains. The San Francisco-based firm has announced that its platform — which it says is the most widely implemented GDPR consent solution among top US and UK sites — is generating an average consent rate over 90 percent.

Although this could be excellent news for the future of GDPR-compliant online marketing and advertising, there are a few caveats.

The greater-than-90 percent rate is the rate averaged across EU-based web domains that provided consent screens — and options to drill down to make more granular choices if desired — to all visitors, including those with European Union IP addresses.

Quantcast did not have a breakdown of consent rates for visitors with US or other non-EU IP addresses, or how the consent rates broke down at the granular levels, such as those who consented to Vendor X for ad targeting but not to Vendor Y for web tracking.

In other words, this is the rate for those who said yes to everything, or yes to some things. But Quantcast did know that 92 percent of those who said yes, or about 81 percent of all users, said yes to everything. The other 8 percent said yes to some things, and drilled down to make granular choices.

The company also did not have the number of EU-based domains participating in this percentage, although it did say its consent solution supports about 9,000 unique domains worldwide.

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The FDA steps up efforts at bringing about medical device cyber security

This FDA guideline seeks to enforce medical device cyber security by ensuring that the manufacturers take steps to secure medical devices by clearly defining medical device cyber security.

It is a disturbing, but true fact that medical devices are hacked. Medical devices have inbuilt software, and hackers try to breach this. Medical device cyber security is thus critical, because lack of it can bring harm to patients who use medical devices that come with software built into them.

An important factor that makes medical devices vulnerable to cyberattacks, thus triggering and hastening the need for medical device cyber security is that many times, medical devices are not standalone devices. They are connected via the Net to a number of important sources such as hospitals, electronic records and healthcare providers.

This fact makes it easier for hackers to carry out cyberattacks on medical devices because it is not necessary for them to actually have access to the device to carry out their breach. All these factors combine to make medical device cyber security a much needed system.

The FDA guideline of June

Keeping in mind the nature of fallibilities in a medical device; the FDA, with the intention of bringing about medical device cyber security passed the draft guideline on this topic in mid-2013. Titled the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; this guideline sought to address the issue of medical device cyber security by making an attempt at identifying the issue from its root.

That is, this guideline on medical device cyber security put in place security checks and procedures that manufacturers of medical device have to put in place right from the earliest stages of manufacture, going all the way up to the time it is implanted in or used by the patient.

The main intention of this FDA medical device cyber security guideline is to offer recommendations that medical device manufacturers need to take to reduce the intentional or unintentional risk of an attack on a medical device. This FDA guideline seeks to enforce medical device cyber security by ensuring that the manufacturers take steps to secure medical devices by clearly defining medical device cyber security.

Terms clearly defined

The FDA defines medical device cyber security as steps taken to prevent any of these:

  • Unauthorized modification
  • Misuse of the device
  • Denying the use of the device
  • Unauthorized use of the information that is stored in these devices. This relates to the information stored, accessed and modified when the device is transferred from one source to another

Documentation is at the heart of ensuring medical device cyber security

Towards ensuring medical device cyber security as defined by it; this FDA guideline requires manufacturers to monitor and document all the aspects of medical device cyber security at all stages. Medical device manufacturers should bring about medical device cyber security by developing a set of controls in three vital areas:

  • Firstly, medical device manufacturers should take steps to permit only authorized personnel into the software of the medical device
  • Medical device manufacturers should also ensure medical device cyber security by filling only relevant and accurate data into the device
  • They should also ensure that data is available when asked for

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The Role of Technology in the Medical Devices Industry

which new technologies have the potential to impact medical devices in a big way?

With almost everything under the sun being touched in one or another way by technology; medical devices are not exempt from this influence. Technology and medical devices have always had a strong bond with each other. Newer technologies that have sprung up over the past few years have accentuated their already strong linkage. So, which new technologies have the potential to impact medical devices in a big way? There are many, but let us consider these among them:

Artificial Intelligence: Undoubtedly, the real shaker for the medical devices industry is AI. AI has been around for a while now, but with the major impetus it received with the advent of the cloud, which makes its monstrous amounts of data manageable, AI’s prowess seems more capable of actualizing. Take IBM Watson for instance. It is being seen as a technology that can alter the landscape of the healthcare industry. Its uses in the medical devices industry too may become more prominent in the years to come.

IoT: The Internet of Things is another phenomenon that could impact medical devices strongly. The day is not far off where we will be able to get IoT to carry out all the manual tasks of the industry today. The most crucial element it could introduce into the industry is likely to be connectivity. Connectivity of medical devices could alter the game for the medical devices industry.

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This Hospital is First in the UK to Treat Cancer Patients with New System

The clinical team sees more than 4,000 new patients each year as a regional centre for rarer types of cancer and also as the local hospital for patients living in the Cambridge area.

Accuray Incorporated announced that the Addenbrooke’s Hospital clinical team has treated the first cancer patients in the United Kingdom with the innovative Radixact® System.

Addenbrooke’s Hospital, part of the Cambridge University Hospitals NHS Foundation Trust, purchased one Radixact System through the NHS England radiotherapy equipment upgrade fund, with a second system funded by the Trust.

These systems have replaced existing, older TomoTherapy® Systems and will improve the treatment process workflow, enabling the clinical team to efficiently deliver highly precise treatments for a broad range of indications.

Addenbrooke’s Hospital is an internationally renowned teaching hospital and designated academic health science centre. The clinical team sees more than 4,000 new patients each year as a regional centre for rarer types of cancer and also as the local hospital for patients living in the Cambridge area.

“Addenbrooke’s Hospital was the first NHS hospital to invest in the TomoTherapy Hi·Art® System and is now the first to secure the Radixact System, which supports our strategy to provide quality cancer care using the most advanced technology available,” said Kevin Skilton, Operational Head of Radiotherapy, Addenbrooke’s Hospital. “We have been extremely pleased with our initial experience using the Radixact System and we look forward to exploring the opportunities the Radixact System may offer us in the treatment of our patients.”

Radixact System Benefits

  • The Radixact System, the next generation TomoTherapy platform, is capable of treating virtually any radiation therapy indication including breast, lung, prostate, and head and neck cancers, in addition to complex treatments such as total marrow irradiation, on a single mainstream platform
  • The system features a more powerful linear accelerator than prior generations, low-dose fan beam 3DCT image guidance and helical delivery technology. These unique features enable clinicians to deliver highly accurate, individualized dose distributions which precisely conform to the shape of the patient’s tumor while minimizing dose to normal, healthy tissue, resulting in fewer side effects for patients
  • A fully-integrated, simplified adaptive treatment planning solution, PreciseART™ Adaptive Radiation Therapy Software, provides clinicians with a unique midcourse decision-making tool and enables them to adapt radiation delivery to changes in tumor size, shape and location within the patient

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5G Wireless can Potentially Help Organizations in [Future]

This improvement over the current wireless broadband technology healthcare organizations are using can support bigger data sets and faster network connections.

The impending release of 5G wireless has organizations considering how they can leverage the technology. The ever-increasing number of connected medical devices leaves wireless networks strained, and the potential of 5G can help increase bandwidth for more devices.

5G is the fifth generation of wireless technology with speeds that could reach up to 20 Gbps, edging out the current 4G LTE which typically clocks in around 1 Gbps. This improvement over the current wireless broadband technology healthcare organizations are using can support bigger data sets and faster network connections.

Connected medical devices are not limited to mobile devices or wireless networks. Organizations need to balance network traffic among wired connections, wireless internet, and cellular connections. This allows organizations to prioritize traffic.

Access points should be broadcasting in 2.4 GHz and 5 GHz, as well as rebroadcasting AM frequency for pagers and cellular for mobile devices. Improving the bandwidth of cellular connections can gives clinicians and patients using smartphones better and faster connections. The more advanced 5G can also better serve telehealth clinicians and patients who are streaming video conferences or transmitting large data sets.

While 5G is not readily available to healthcare organizations yet, improvements have been made on the technology over the past year. The 5G market  is expected to grow at a CAGR of 70 percent through 2025, according to Market Reports Center.

Report authors stated that the 5G wireless ecosystem is expected to grow soon because of the initiatives taken by national and regional governments along with network providers and wireless carriers.

The report predicted that large-scale commercial trials will increase by five times through 2021. Report authors also predicted that 5G will have a large impact on IoT devices, haptic internet, virtual reality, and robotics.

Healthcare organizations are eager to embrace IoT devices because they save money by keeping patients out of the hospital.

“If IoT devices can diagnose people in advance then that saves huge costs,” Taoglas Co-Founder and Co-CEO Dermot O’Shea told HITInfrastructure.com in a previous interview.. “We can see nothing but benefits from medical devices being connected. Working with medical device companies brings a much larger delta of savings and benefits than any other vertical.”

The benefits of 5G in healthcare has prompted vendors to collaborate and seek a standardized technology to improve device connectivity.

Earlier this year, Qualcomm, Ericsson, and AT&T announced plans to collaborate and conduct interoperability testing and over-the-air field trials based on the expected 5G New Radio (NR) specifications under development by the 3rd Generation Partnership Project (3GPP).

The partnership was formed in response to the demand for advanced wireless technology for enterprises seeking new revenue streams requiring mobile or remote data exchanges, such as telehealth and remote care.

Vendors and customers alike are seeking faster and more reliable cellular connections, but much testing still needs to be conducted before a standard technology can be deployed.

“The roadmap of 5G technologies is complex, and collaborations such as this are critical to ensuring timely deployment of 5G networks,” Qualcomm Technologies Executive Vice President and CTO Matt Grob said on the collaboration.

“The 3GPP-based trials we are planning with AT&T and Ericsson will help us accelerate integration of advanced 5G New Radio technologies in form-factor accurate devices, building upon our long history of 3G and 4G LTE leadership and paving the path to wide-scale 5G deployments.”

Healthcare IoT devices are valuable to organizations because of the insight and monitoring services they provide. However, the more devices are introduced into health IT infrastructures, the more robust and reliable the network needs to be. 5G research is important to healthcare entities because its success will allow them to embrace more IoT devices.

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