Medical Devices R&D Investment | Leaders in Pharmaceutical Business Intelligence (LPBI) Group

Archive for the ‘Medical Devices R&D Investment’ Category

The top 10 medtech M&A deals of 2020

Posted in BioTechnology - Venture Creation, BioTechnology - Venture Creation, Venture Capital, Medical Devices R&D Investment on April 14, 2021| Leave a Comment »

The top 10 medtech M&A deals of 2020

Reporter: Aviva Lev-Ari, PhD, RN

SOURCE

https://www.fiercebiotech.com/special-report/top-10-medtech-m-a-deals-2020?mkt_tok=Mjk0LU1RRi0wNTYAAAF8b8P08fCVQbG0SbLpWA3UUMD8cSMgviRFJa-h5SS2VqM_tzQe7KrH-azzlvoPTPPo5YR_TOFou992WYr7G5A-qtyq0U8pcxVCC57EWBRHl3RQYLU&mrkid=993697

Read Full Post »

Two brothers with MEPAN Syndrome: A Rare Genetic Disorder

Posted in Academic Publishing, Behavioral Genetics, Biological Networks, Biomarkers & Medical Diagnostics, Cerebrovascular and Neurodegenerative Diseases, Chemical Biology and its relations to Metabolic Disease, Clinical Diagnostics, Clinical Genomics, Disease Biology, Medical Devices R&D Investment, Metabolism, Molecular Genetics & Pharmaceutical, MRI, mtDNA, Neurodegenerative Diseases, Neurological Diseases, Oxidative phosphorylation, tagged Ataxia, dystonia, MECR gene, MEPAN Foundation, MEPAN syndrome, Metabolic processes, mtDNA, Neurological disease, NIH Undiagnosed Diseases Network, Optic atrophy, OXPHOS Deficiencies, Rare Genetic Disorder, Whole-genome or whole-exome sequencing on March 21, 2021| Leave a Comment »

Two brothers with MEPAN Syndrome: A Rare Genetic Disorder

Reporter: Amandeep Kaur

In the early 40s, a married couple named Danny and Nikki, had normal pregnancy and delivered their first child in October 2011. The couple was elated after the birth of Carson because they were uncertain about even conceiving a baby. Soon after birth, the parents started facing difficulty in feeding the newborn and had some wakeful nights, which they used to called “witching hours”. For initial six months, they were clueless that something was not correct with their infant. Shortly, they found issues in moving ability, sitting, and crawling with Carson. Their next half year went in visiting several behavioral specialists and pediatricians with no conclusion other than a suggestion that there is nothing to panic as children grow at different rates.

Later in early 2013, Caron was detected with cerebral palsy in a local regional center. The diagnosis was based on his disability to talk and delay in motor development. At the same time, Carson had his first MRI which showed no negative results. The parents convinced themselves that their child condition would be solved by therapies and thus started physical and occupational therapies. After two years, the couple gave birth to another boy child named Chase in 2013. Initially, there was nothing wrong with Chase as well. But after nine months, Chase was found to possess the same symptoms of delaying in motor development as his elder brother. It was expected that Chase may also be suffering from cerebral palsy. For around one year both boys went through enormous diagnostic tests starting from karyotyping, metabolic screen tests to diagnostic tests for Fragile X syndrome, lysosomal storage disorders, Friedreich ataxia and spinocerebellar ataxia. Gene panel tests for mitochondrial DNA and Oxidative phosphorylation (OXPHOS) deficiencies were also performed. No conclusion was drawn because each diagnostic test showed the negative results.

Over the years, the condition of boys was deteriorating as their movements became stiffer and ataxic, they were not able to crawl anymore. By the end of 2015, the boys had an MRI which showed some symmetric anomalies in their basal ganglia indicating a metabolic condition. The symptoms of Carson and Chase was not even explained by whole exome sequencing due to the absence of any positive result. The grievous journey of visits to neurologist, diagnostic tests and inconclusive results led the parents to rethink about anything happened erroneous due to them such as due to their lifestyle, insufficient intake of vitamins during pregnancy or exposure to toxic agents which left their sons in that situation.

During the diagnostic odyssey, Danny spent many restless and sleepless nights in searching PubMed for any recent cases with symptoms similar to his sons and eventually came across the NIH’s Undiagnosed Diseases Network (UDN), which gave a light of hope to the demoralized family. As soon as Danny discovered about the NIH’s Diseases Network, he gathered all the medical documents of both his sons and submitted the application. The submitted application in late 2015 got accepted a year later in December 2016 and they got their first appointment in early 2017 at the UDN site at Stanford. At Stanford, the boys had gone through whole-genome sequencing and some series of examinations which came back with inconclusive results. Finally, in February 2018, the family received some conclusive results which explained that the two boys suffer from MEPAN syndrome with pathogenic mutations in MECR gene.

MEPAN means Mitochondrial Enoyl CoA reductase Protein-Associated Neurodegeneration
MEPAN syndrome is a rare genetic neurological disorder
MEPAN syndrome is associated with symptoms of ataxia, optic atrophy and dystonia
The wild-type MECR gene encodes a mitochondrial protein which is involved in metabolic processes
The prevalence rate of MEPAN syndrome is 1 in 1 million
Currently, there are 17 patients of MEPAN syndrome worldwide

The symptoms of Carson and Chase of an early onset of motor development with no appropriate biomarkers and T-2 hyperintensity in the basal ganglia were matching with the seven known MEPAN patient at that time. The agonizing journey of five years concluded with diagnosis of rare genetic disorder.

Despite the advances in genetic testing and their low-cost, there are many families which still suffer and left undiagnostic for long years. To shorten the diagnostic journey of undiagnosed patients, the whole-exome and whole-genome sequencing can be used as a primary tool. There is need of more research to find appropriate treatments of genetic disorders and therapies to reduce the suffering of the patients and families. It is necessary to fill the gap between the researchers and clinicians to stimulate the development in diagnosis, treatment and drug development for rare genetic disorders.

The family started a foundation named “MEPAN Foundation” (https://www.mepan. org) to reach out to the world to educate people about the mutation in MECR gene. By creating awareness among the communities, clinicians, and researchers worldwide, the patients having rare genetic disorder can come closer and share their information to improve their condition and quality of life.

Reference: Danny Miller, The diagnostic odyssey: our family’s story, The American Journal of Human Genetics, Volume 108, Issue 2, 2021, Pages 217-218, ISSN 0002-9297, https://doi.org/10.1016/j.ajhg.2021.01.003 (https://www.sciencedirect.com/science/article/pii/S0002929721000033)

Sources:

https://www.variantyx.com/2020/02/26/in-silico-panel-expansion/

https://www.orpha.net/consor/cgi-bin/OC_Exp.php?lng=EN&Expert=508093

https://www.mepan. org

Other related articles were published in this Open Access Online Scientific Journal, including the following:

Effect of mitochondrial stress on epigenetic modifiers

Larry H. Bernstein, MD, FCAP, Curator, LPBI

https://pharmaceuticalintelligence.com/2016/05/07/effect-of-mitochondrial-stress-on-epigenetic-modifiers/

The Three Parent Technique to Avoid Mitochondrial Disease in Embryo

Reporter and Curator: Dr. Sudipta Saha, Ph.D.

https://pharmaceuticalintelligence.com/2016/10/07/the-three-parent-technique-to-avoid-mitochondrial-disease-in-embryo/

New Insights into mtDNA, mitochondrial proteins, aging, and metabolic control

Larry H. Bernstein, MD, FCAP, Curator, LPBI

https://pharmaceuticalintelligence.com/2016/04/20/new-insights-into-mtdna-mitochondrial-proteins-aging-and-metabolic-control/

Mitochondrial Isocitrate Dehydrogenase and Variants

Writer and Curator: Larry H. Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2015/04/02/mitochondrial-isocitrate-dehydrogenase-and-variants/

Update on mitochondrial function, respiration, and associated disorders

Larry H. Benstein, MD, FCAP, Gurator and writer

https://pharmaceuticalintelligence.com/2014/07/08/update-on-mitochondrial-function-respiration-and-associated-disorders/

Read Full Post »

mHealth market growth in America, Europe, & APAC

Posted in Health Care System by Country, Health Economics and Outcomes Research, Hospital-based Medical Innovations, Investment in Technological Breakthrough, Medical Devices R&D Investment on October 19, 2020| Leave a Comment »

mHealth market growth in America, Europe, & APAC

Reporter on this Industry News: Aviva Lev-Ari, PhD, RN

An industry news titled ‘Pivotal trends propelling mHealth market growth in America, Europe, & APAC’ by Graphical Research released on 10/19/2020

Pivotal trends propelling mHealth market growth in America, Europe, & APAC

Rapid expansion of digital healthcare for the provision of delivery, medical support, and intervention through mobile technologies is likely to augment mHealth market expansion through the coming years. Active involvement of patients toward bettering their own health will further contribute to mHealth market growth over the forecast period.

The recent years have witnessed an upsurge in government initiatives in the mHealth technology sector in turn prompting major market players to get involved in product development and promotion programs at both regional and global level.

Prominent trends likely to propel the regional expansion of mHealth market:

Rising internet penetration to push North America mHealth revenue share

Surging internet and mobile phone penetration coupled with a rise in the usage of healthcare mobile applications has been instrumental in creating a high demand for mobile health devices in the region. North America mHealth market will surpass USD 113 bn by 2026, with an estimated CAGR of 39.5%, having registered a valuation of 11,364.1 million in 2019.

Surging demand for fitness apps for the maintenance of healthy body in Canada and the U.S. has been instrumental in impelling the growth of mHealth apps segment in the region. Mobile apps contributed a revenue of USD 7,877.2 million holding the largest revenue share in 2019.

In terms of the end-use spectrum, physicians’ segment was worth USD 3,431.1 million in 2019. The segment in fact, accounted for the largest revenue share in the year. The growth can be aptly credited to the rising adoption of digitization in medical care facilities, in tandem with the increasing healthcare spending in the region.

Around 2,000 healthcare providers in San Francisco presently utilize mHealth wearables for temperature monitoring for the identification of people who have been infected with COVID-19, cites study. Increasing use of healthcare wearables will thus propel North America mHealth industry outlook over the coming years.

Rising technological advancements in Europe mHealth market

Increasing adoption of leading-edge technology for the minimization of extra bulk devices usage for blood glucose level monitoring will add to industry expansion in the region.

Europe mhealth market size will exceed USD 137.5 billion valuation by 2026 with a targeted CAGR of 39%, having registered a revenue of USD 14,162.0 million in 2019.

The International Diabetes Foundation (IDF) has stated that about 9.1 per cent of the people in Europe suffered from diabetes in 2017. Scientists are on the path of developing skin-based glucose monitor for the purpose of detecting glucose levels in sweat, opening up avenues for Europe mHealth market expansion in the near future.

Reports state that Germany accounted for 20 per cent of the overall market share in 2019 and is poised to witness commendable growth in the coming years, driven by the rising advancements in the ehealth technology sector in the region. The hardware segment pertaining to the use of medical devices and mobile sensors will augment Europe mHealth market size over the estimated period. What’s more, the region has been manifesting proliferating trends pertaining to health and fitness consciousness as well as healthcare digitalization that’ll further boost the regional growth.

Prominent players in the Europe mHealth industry comprise Masimo Corporation, Allscripts Healthcare Solutions, Cardionet, AT&T, Qualcomm, Apple, Philips Healthcare, Boston Scientific, and others.

Latin America mHealth market to gain massive proceeds from remote data collection

Remote data collection in Latin America accounted for a valuation of USD 523.6 million in 2019 and is estimated to account for a remarkable revenue share over the forecast period. Latin America mHealth industry is slated to depict a commendable CAGR of 40.7 per cent over 2020 to 2026.

The largest segmental share can be attributed to the transmission and collection of data through mobile phones. The system has been designed for sending messages or e-mails given the data is aggregated in a centralized database and the symptoms are recorded.

Based on application, Latin America mHealth market has been segmented into disease and epidemic outbreak tracking, communication and training, remote data collection, education and awareness, diagnostics and treatment, remote monitoring, and others.

According to a 2017 study, over 40 million patients in Mexico and Brazil were treated through mobile health services. Patients segment in the Latin America mHealth market will witness lucrative growth at a CAGR of 41.6 per cent over the estimated timeframe. This will also create remarkable mHealth deployments and lucrative job opportunities, in turn adding to mHealth product adoption over the estimated period.

Rising government intervention to bolster Asia Pacific mHealth market over the forecast period

Surging consumer awareness is likely to bolster regional mHealth product demand over the forecast period. The Asia Pacific mHealth industry will register an appreciable CAGR of 41.1 per cent from 2020 to 2026.

The rise is primarily attributed to the surging government interventions coupled with the substantial growth in developing economies. As per the National Center for Biotechnology Information, highest number of mHealth program initiatives have been undertaken owing to considerable government investments in healthcare sector across the region.

Various limitations pertaining to availability and the access to healthcare services in addition to inaccurate results emerging from discrepancies in mHealth devices will, however, hinder mHealth industry growth in the Asia Pacific region.

Improving global access pertaining to point-of-care tools for supporting enhanced patient outcomes and better clinical decision making will, thus, improve and bolster mHealth business landscape over the coming years. Rising focus of industry players on application strategies for the purpose of fighting chronic diseases will further spur industry expansion.

SOURCE

From: <pradip.s@graphicalresearch.com>

Date: Monday, October 19, 2020 at 12:39 PM

To: “Aviva Lev-Ari, PhD, RN” <AvivaLev-Ari@alum.berkeley.edu>

Subject: Exclusive Article On “mHealth market”

Dear Editor,

An industry news titled ‘Pivotal trends propelling mHealth market growth in America, Europe, & APAC’ by Graphical Research is relevant to your esteemed website https://pharmaceuticalintelligence.com/ . This email is a suggestion to publish this news (content attached in word format) on your website with an objective to share the information with your audiences.

Looking forward to hear from you.

Regards,

Pradip Shitole | Sr. SEO Executive

Graphical Research

Web: https://www.graphicalresearch.com/

Connect with us: LinkedIn | Facebook | Twitter

Read Full Post »

The Regulatory challenge in adopting AI

Posted in An executive's guide to AI, Artificial Intelligence - Breakthroughs in Theories and Technologies, Artificial Intelligence - General, Artificial intelligence applications for cardiology, Artificial Intelligence Applications in Health Care, Artificial Intelligence in Health Care - Tools & Innovations, Artificial Intelligence in Medicine - Application for Diagnosis, Artificial Intelligence in Medicine - Applications in Therapeutics, CE Mark & Global Regulatory Affairs: process management and strategic planning - GCP, FDA, FDA Regulatory Affairs, FDA, CE Mark & Global Regulatory Affairs: process management and strategic planning - GCP, GLP, ISO 14155, ISO 10993 for Product Registration: FDA & CE Mark for Development of Medical Devices and Diagnostics, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Uncategorized on April 7, 2019| Leave a Comment »

The Regulatory challenge in adopting AI

Author and Curator: Dror Nir, PhD

3.4.3 The Regulatory challenge in adopting AI, Volume 2 (Volume Two: Latest in Genomics Methodologies for Therapeutics: Gene Editing, NGS and BioInformatics, Simulations and the Genome Ontology), Part 2: CRISPR for Gene Editing and DNA Repair

In the last couple of years we are witnessing a surge of AI applications in healthcare. It is clear now, that AI and its wide range of health-applications are about to revolutionize diseases’ pathways and the way the variety of stakeholders in this market interact.

Not surprisingly, the developing surge has waken the regulatory watchdogs who are now debating ways to manage the introduction of such applications to healthcare. Attributing measures to known regulatory checkboxes like safety, and efficacy is proving to be a complex exercise. How to align claims made by manufacturers, use cases, users’ expectations and public expectations is unclear. A recent demonstration of that is the so called “failure” of AI in social-network applications like FaceBook and Twitter in handling harmful materials.

‘Advancing AI in the NHS’ – is a report covering the challenges and opportunities of AI in the NHS. It is a modest contribution to the debate in such a timely and fast-moving field! I bring here the report’s preface and executive summary hoping that whoever is interested in reading the whole 50 pages of it will follow this link: f53ce9_e4e9c4de7f3c446fb1a089615492ba8c

Acknowledgements

We and Polygeia as a whole are grateful to Dr Dror Nir, Director, RadBee, whose insights

were valuable throughout the research, conceptualisation, and writing phases of this work; and to Dr Giorgio Quer, Senior Research Scientist, Scripps Research Institute; Dr Matt Willis, Oxford Internet Institute, University of Oxford; Professor Eric T. Meyer, Oxford Internet Institute, University of Oxford; Alexander Hitchcock, Senior Researcher, Reform; Windi Hari, Vice President Clinical, Quality & Regulatory, HeartFlow; Jon Holmes, co-founder and Chief Technology Officer, Vivosight; and Claudia Hartman, School of Anthropology & Museum Ethnography, University of Oxford for their advice and support.

Author affiliations

Lev Tankelevitch, University of Oxford

Alice Ahn, University of Oxford

Rachel Paterson, University of Oxford

Matthew Reid, University of Oxford

Emily Hilbourne, University of Oxford

Bryan Adriaanse, University of Oxford

Giorgio Quer, Scripps Research Institute

Dror Nir, RadBee

Parth Patel, University of Cambridge

All affiliations are at the time of writing.

Polygeia

Polygeia is an independent, non-party, and non-profit think-tank focusing on health and its intersection with technology, politics, and economics. Our aim is to produce high-quality research on global health issues and policies. With branches in Oxford, Cambridge, London and New York, our work has led to policy reports, peer-reviewed publications, and presentations at the House of Commons and the European Parliament. http://www.polygeia.com @Polygeia © Polygeia 2018. All rights reserved.

Foreword

Almost every day, as MP for Cambridge, I am told of new innovations and developments that show that we are on the cusp of a technological revolution across the sectors. This technology is capable of revolutionising the way we work; incredible innovations which could increase our accuracy, productivity and efficiency and improve our capacity for creativity and innovation.

But huge change, particularly through adoption of new technology, can be difficult to communicate to the public, and if we do not make sure that we explain carefully the real benefits of such technologies we easily risk a backlash. Despite good intentions, the care.data programme failed to win public trust, with widespread worries that the appropriate safeguards weren’t in place, and a failure to properly explain potential benefits to patients. It is vital that the checks and balances we put in place are robust enough to sooth public anxiety, and prevent problems which could lead to steps back, rather than forwards.

Previous attempts to introduce digital innovation into the NHS also teach us that cross-disciplinary and cross-sector collaboration is essential. Realising this technological revolution in healthcare will require industry, academia and the NHS to work together and share their expertise to ensure that technical innovations are developed and adopted in ways that prioritise patient health, rather than innovation for its own sake. Alongside this, we must make sure that the NHS workforce whose practice will be altered by AI are on side. Consultation and education are key, and this report details well the skills that will be vital to NHS adoption of AI. Technology is only as good as those who use it, and for this, we must listen to the medical and healthcare professionals who will rightly know best the concerns both of patients and their colleagues. The new Centre for Data Ethics and Innovation, the ICO and the National Data Guardian will be key in working alongside the NHS to create both a regulatory framework and the communications which win society’s trust. With this, and with real leadership from the sector and from politicians, focused on the rights and concerns of individuals, AI can be advanced in the NHS to help keep us all healthy.

Daniel Zeichner

MP for Cambridge

Chair, All-Party Parliamentary Group on Data Analytics

Executive summary

Artificial intelligence (AI) has the potential to transform how the NHS delivers care. From enabling patients to self-care and manage long-term conditions, to advancing triage, diagnostics, treatment, research, and resource management, AI can improve patient outcomes and increase efficiency. Achieving this potential, however, requires addressing a number of ethical, social, legal, and technical challenges. This report describes these challenges within the context of healthcare and offers directions forward.

Data governance

AI-assisted healthcare will demand better collection and sharing of health data between NHS, industry and academic stakeholders. This requires a data governance system that ensures ethical management of health data and enables its use for the improvement of healthcare delivery. Data sharing must be supported by patients. The recently launched NHS data opt-out programme is an important starting point, and will require monitoring to ensure that it has the transparency and clarity to avoid exploiting the public’s lack of awareness and understanding. Data sharing must also be streamlined and mutually beneficial. Current NHS data sharing practices are disjointed and difficult to negotiate from both industry and NHS perspectives. This issue is complicated by the increasing integration of ’traditional’ health data with that from commercial apps and wearables. Finding approaches to valuate data, and considering how patients, the NHS and its partners can benefit from data sharing is key to developing a data sharing framework. Finally, data sharing should be underpinned by digital infrastructure that enables cybersecurity and accountability.

Digital infrastructure

Developing and deploying AI-assisted healthcare requires high quantity and quality digital data. This demands effective digitisation of the NHS, especially within secondary care, involving not only the transformation of paper-based records into digital data, but also improvement of quality assurance practices and increased data linkage. Beyond data digitisation, broader IT infrastructure also needs upgrading, including the use of innovations such as wearable technology and interoperability between NHS sectors and institutions. This would not only increase data availability for AI development, but also provide patients with seamless healthcare delivery, putting the NHS at the vanguard of healthcare innovation.

Standards

The recent advances in AI and the surrounding hype has meant that the development of AI-assisted healthcare remains haphazard across the industry, with quality being difﬁcult to determine or varying widely. Without adequate product validation, including in

real-world settings, there is a risk of unexpected or unintended performance, such as sociodemographic biases or errors arising from inappropriate human-AI interaction. There is a need to develop standardised ways to probe training data, to agree upon clinically-relevant performance benchmarks, and to design approaches to enable and evaluate algorithm interpretability for productive human-AI interaction. In all of these areas, standardised does not necessarily mean one-size-ﬁts-all. These issues require addressing the speciﬁcs of AI within a healthcare context, with consideration of users’ expertise, their environment, and products’ intended use. This calls for a fundamentally interdisciplinary approach, including experts in AI, medicine, ethics, cognitive science, usability design, and ethnography.

Regulations

Despite the recognition of AI-assisted healthcare products as medical devices, current regulatory efforts by the UK Medicines and Healthcare Products Regulatory Agency and the European Commission have yet to be accompanied by detailed guidelines which address questions concerning AI product classiﬁcation, validation, and monitoring. This is compounded by the uncertainty surrounding Brexit and the UK’s future relationship with the European Medicines Agency. The absence of regulatory clarity risks compromising patient safety and stalling the development of AI-assisted healthcare. Close working partnerships involving regulators, industry members, healthcare institutions, and independent AI-related bodies (for example, as part of regulatory sandboxes) will be needed to enable innovation while ensuring patient safety.

The workforce

AI will be a tool for the healthcare workforce. Harnessing its utility to improve care requires an expanded workforce with the digital skills necessary for both developing AI capability and for working productively with the technology as it becomes commonplace.

Developing capability for AI will involve ﬁnding ways to increase the number of clinician-informaticians who can lead the development, procurement and adoption of AI technology while ensuring that innovation remains tied to the human aspect of healthcare delivery. More broadly, healthcare professionals will need to complement their socio-emotional and cognitive skills with training to appropriately interpret information provided by AI products and communicate it effectively to co-workers and patients.

Although much effort has gone into predicting how many jobs will be affected by AI-driven automation, understanding the impact on the healthcare workforce will require examining how jobs will change, not simply how many will change.

Legal liability

AI-assisted healthcare has implications for the legal liability framework: who should be held responsible in the case of a medical error involving AI? Addressing the question of liability will involve understanding how healthcare professionals’ duty of care will be impacted by use of the technology. This is tied to the lack of training standards for healthcare professionals to safely and effectively work with AI, and to the challenges of algorithm interpretability, with ”black-box” systems forcing healthcare professionals to blindly trust or distrust their output. More broadly, it will be important to examine the legal liability of healthcare professionals, NHS trusts and industry partners, raising questions

Recommendations

The NHS, the Centre for Data Ethics and Innovation, and industry and academic partners should conduct a review to understand the obstacles that the NHS and external organisations face around data sharing. They should also develop health data valuation protocols which consider the perspectives of patients, the NHS, commercial organisations, and academia. This work should inform the development of a data sharing framework.
The National Data Guardian and the Department of Health should monitor the NHS data opt-out programme and its approach to transparency and communication, evaluating how the public understands commercial and non-commercial data use and the handling of data at different levels of anonymisation.
The NHS, patient advocacy groups, and commercial organisations should expand public engagement strategies around data governance, including discussions about the value of health data for improving healthcare; public and private sector interactions in the development of AI-assisted healthcare; and the NHS’s strategies around data anonymisation, accountability, and commercial partnerships. Findings from this work should inform the development of a data sharing framework.
The NHS Digital Security Operations Centre should ensure that all NHS organisations comply with cybersecurity standards, including having up-to-date technology.
NHS Digital, the Centre for Data Ethics and Innovation, and the Alan Turing Institute should develop technological approaches to data privacy, auditing, and accountability that could be implemented in the NHS. This should include learning from Global Digital Exemplar trusts in the UK and from international examples such as Estonia.
The NHS should continue to increase the quantity, quality, and diversity of digital health data across trusts. It should consider targeted projects, in partnership with professional medical bodies, that quality-assure and curate datasets for more deployment-ready AI technology. It should also continue to develop its broader IT infrastructure, focusing on interoperability between sectors, institutions, and technologies, and including the end users as central stakeholders.
The Alan Turing Institute, the Ada Lovelace Institute, and academic and industry partners in medicine and AI should develop ethical frameworks and technological approaches for the validation of training data in the healthcare sector, including methods to minimise performance biases and validate continuously-learning algorithms.
The Alan Turing Institute, the Ada Lovelace Institute, and academic and industry partners in medicine and AI should develop standardised approaches for evaluating product performance in the healthcare sector, with consideration for existing human performance standards and products’ intended use.
The Alan Turing Institute, the Ada Lovelace Institute, and academic and industry partners in medicine and AI should develop methods of enabling and evaluating algorithm interpretability in the healthcare sector. This work should involve experts in AI, medicine, ethics, usability design, cognitive science, and ethnography, among others.
Developers of AI products and NHS Commissioners should ensure that usability design remains a top priority in their respective development and procurement of AI-assisted healthcare products.
The Medicines and Healthcare Products Regulatory Agency should establish a digital health unit with expertise in AI and digital products that will work together with manufacturers, healthcare bodies, notiﬁed bodies, AI-related organisations, and international forums to advance clear regulatory approaches and guidelines around AI product classiﬁcation, validation, and monitoring. This should address issues including training data and biases, performance evaluation, algorithm interpretability, and usability.
The Medicines and Healthcare Products Regulatory Agency, the Centre for Data Ethics and Innovation, and industry partners should evaluate regulatory approaches, such as regulatory sandboxing, that can foster innovation in AI-assisted healthcare, ensure patient safety, and inform on-going regulatory development.
The NHS should expand innovation acceleration programmes that bridge healthcare and industry partners, with a focus on increasing validation of AI products in real-world contexts and informing the development of a regulatory framework.
The Medicines and Healthcare Products Regulatory Agency and other Government bodies should arrange a post-Brexit agreement ensuring that UK regulations of medical devices, including AI-assisted healthcare, are aligned as closely as possible to the European framework and that the UK can continue to help shape Europe-wide regulations around this technology.
The General Medical Council, the Medical Royal Colleges, Health Education England, and AI-related bodies should partner with industry and academia on comprehensive examinations of the healthcare sector to assess which, when, and how jobs will be impacted by AI, including analyses of the current strengths, limitations, and workﬂows of healthcare professionals and broader NHS staff. They should also examine how AI-driven workforce changes will impact patient outcomes.
The Federation of Informatics Professionals and the Faculty of Clinical Informatics should continue to lead and expand standards for health informatics competencies, integrating the relevant aspects of AI into their training, accreditation, and professional development programmes for clinician-informaticians and related professions.
Health Education England should expand training programmes to advance digital and AI-related skills among healthcare professionals. Competency standards for working with AI should be identiﬁed for each role and established in accordance with professional registration bodies such as the General Medical Council. Training programmes should ensure that ”un-automatable” socio-emotional and cognitive skills remain an important focus.
The NHS Digital Academy should expand recruitment and training efforts to increase the number of Chief Clinical Information Ofﬁcers across the NHS, and ensure that the latest AI ethics, standards, and innovations are embedded in their training programme.
Legal experts, ethicists, AI-related bodies, professional medical bodies, and industry should review the implications of AI-assisted healthcare for legal liability. This includes understanding how healthcare professionals’ duty of care will be affected, the role of workforce training and product validation standards, and the potential role of NHS Indemnity and no-fault compensation systems.
AI-related bodies such as the Ada Lovelace Institute, patient advocacy groups and other healthcare stakeholders should lead a public engagement and dialogue strategy to understand the public’s views on liability for AI-assisted healthcare.

Read Full Post »

#JPM19 Conference: Dublin HealthBeacon Raises Funding

Posted in Digital HealthCare – biotech & internet joint ventures, Investment in Technological Breakthrough, Medical Devices R&D Investment, Medication Remote Compliance Monitoring, Uncategorized, Voices of Patients and Healthcare Providers, Wearable Tech + Digital Health, tagged Boston, Entrepreneur, Funding, health, Life Sciences, Medical Devices R&D Investment, Medical technology on January 9, 2019| Leave a Comment »

News announced during the 37th J.P. Morgan Healthcare Conference (#JPM19): Dublin medtech HealthBeacon raises $12m in a Series A round

Reporter: Gail S. Thornton

HealthBeacon’s Smart Sharps system helps patients adhere to their medication schedule. The company was founded by Jim Joyce and Kieran Daly in 2013, and opened offices in Boston in 2017. The digital platform, which last year received vital FDA clearance for the US market, not only ensures that patients keep up with their injectable treatments, but also allows them to dispose of medication in a safe way, and keeps carers up to date with the patients’ progress.

Published January 8, 2019 by John Kennedy, Silicon Republic.

From left: Co-founders Kieran Daly and Jim Joyce. Image: HealthBeacon

With funding and FDA approval under its belt, this Dublin tech start-up has plans to help patients stick to their medication schedule.

Dublin and Boston digital health company HealthBeacon has raised $12m in a Series A investment round that brings total investment in the company to almost $15m.

The round was organised by HealthBeacon and Cantor Fitzgerald, led by Oyster Capital and Elkstone Partners, and the investment syndicate included Quorndon Capital and Cantor Fitzgerald’s private client group. Earlier investors in HealthBeacon include Enterprise Ireland, BVP and a range of angel investors.

‘I know with confidence as to whether my patients are adhering to their treatment strategy’
^{– DOUG VEALE}

“Cantor has a major focus on life sciences and on digital health, and we have every confidence that CEO and co-founder Jim Joyce has created a true sector leader in HealthBeacon,” said Liam Kiely, director of Cantor Fitzgerald.

The announcement was made in San Francisco at the JPMorgan Chase Biotech Showcase. The funding comes on the back of rapid global expansion of the FDA-cleared HealthBeacon Smart Sharps technology.

The right stuff

Dublin-based HealthBeacon’s Smart Sharps system helps patients adhere to their medication schedule. The company was founded by Jim Joyce and Kieran Daly in 2013, and opened offices in Boston in 2017.

The digital platform, which last year received vital FDA clearance for the US market, not only ensures that patients keep up with their injectable treatments, but also allows them to dispose of medication in a safe way, and keeps carers up to date with the patients’ progress.

The funding from this Series A will be used to launch its Smart Sharps system in the US and to develop its portfolio of medical adherence tools for high-value medications.

In 2017, HealthBeacon revealed plans to create 20 new jobs in Dublinin roles spanning IT, software development, project management and customer service. As of today, HealthBeacon operates in 10 markets and has tracked more than 200,000 home-based injections, making it one of the largest global deployments of a medical adherence device. Today, HealthBeacon employs more than 30 people and plans to double the team over the next 18 months.

The addressable market for injectable medications has reached nearly $50bn, according to the company. The Smart Sharps bin system by HealthBeacon has made it easier for patients using injectable medications to stay on track with their treatment. This has resulted in improved patient medication adherence, driving patient care.

In December, HealthBeacon was named eHealth Innovation of the Year by the Irish Medtech Association.

“I’ve been using the HealthBeacon for over two years, and their Smart Sharps bin has had a profound impact on how patients manage their treatment,” said Doug Veale, professor of rheumatology at St Vincent’s Hospital in Dublin.

“I know with confidence as to whether my patients are adhering to their treatment strategy.”

Editor John Kennedy is an award-winning technology journalist.

editorial@siliconrepublic.com

SOURCE

https://www.siliconrepublic.com/start-ups/healthbeacon-series-a-investment

37th Annual J.P. Morgan HEALTHCARE CONFERENCE: News at #JPM2019 for Jan. 8, 2019: Deals and Announcements

Read Full Post »

Rhythm Management Device Hardware (Dual-chamber Pacemaker) coupled with BackBeat’s Cardiac Neuromodulation Therapy (CNT) bioelectronic therapy for Lowering Systolic Blood Pressure for patients with Pacemakers

Posted in BackBeat's Cardiac Neuromodulation Therapy (CNT) bioelectronic therapy, Frontiers in Cardiology and Cardiovascular Disorders, Medical Devices R&D and Inventions, Rare heart rhythm disorders and Long QT syndrome (LQTS), Rhythm management device hardware: dual-chamber pacemakers, Systolic HTN on October 3, 2018| Leave a Comment »

Rhythm Management Device Hardware (Dual-chamber Pacemaker) coupled with BackBeat’s Cardiac Neuromodulation Therapy (CNT) bioelectronic therapy for Lowering Systolic Blood Pressure for patients with Pacemakers

Reporter: Aviva Lev-Ari, PhD, RN

BackBeat’s CNT is a bioelectronic therapy that immediately, substantially and chronically lowers blood pressure (BP) while simultaneously modulating the autonomic nervous system (ANS). Mimicking the effects of multiple medications by reducing pre-load, after-load and sympathetic tone, it can be delivered using standard rhythm management device hardware such as dual-chamber pacemakers.

For more information: www.orchestrabiomed.com

October 2, 2018 — Two-year results of the Moderato I Study demonstrated immediate, substantial and sustained reduction in blood pressure when BackBeat cardiac neuromodulation therapy (CNT) was used in patients with persistent hypertension (office BP > 150mmHg). Patients in the study had persistent hypertension despite two or more anti-hypertensive medications and an indication for a pacemaker.

Results of the multicenter clinical trial were presented at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) conference, Sept. 21-25 in San Diego, by Daniel Burkhoff, M.D., Ph.D., director, heart failure, hemodynamics and mechanical circulatory support research for the Cardiovascular Research Foundation (CRF).

“The clinical efficacy and safety data observed with BackBeat CNT in a patient population with a significant portion of isolated systolic disease is very promising. Hypertension affects over 70 percent of pacemaker patients. These patients could benefit substantially from a potent hypertension therapy such as BackBeat CNT that could be included in their already necessary pacemaker,” said Prof. Petr Neuzil, M.D., head of the Department of Cardiology of Na Homolce Hospital in Prague, Czech Republic and one of the principal investigators of the study.

The 27 patients that met the study inclusion criteria were implanted with BackBeat’s proprietary Moderato dual-chamber pacemaker that incorporates the BackBeat CNT algorithms. The primary safety and efficacy endpoint results of the study were as follows:

Efficacy Outcomes: Immediate, substantial and sustained reduction in blood pressure.

14.2 mmHg decrease from baseline (p<0.001) in 24 hours ambulatory systolic blood pressure (AMB BP) at 3 months

23.4 mmHg decrease from baseline (p < 0.001) in systolic blood pressure (SBP) sustained out to 2 years

High responder rate in a population where 78 percent of patients had isolated systolic hypertension.

85 percent AMB BP reduced >5mmHg

74 percent AMB BP reduced >10 mmHg

Safety Outcomes: The study met the safety endpoint.

Observed reduction in end systolic and diastolic volumes with no change to ejection fraction suggests improvement of cardiac function

Observed reduction in heart rate out to 2 years indicative of reduced sympathetic activity

“These statistically significant results demonstrate the potential for BackBeat CNT to be a broadly applicable therapy that substantially lowers blood pressure immediately and maintains reduced pressures for years,” commented Burkhoff. “It is rare to see a new therapy show such dramatic and sustained effects in such a small number of patients.”

To further investigate the efficacy and safety of BackBeat CNT for the treatment of hypertension, Orchestra BioMed is enrolling patients into a prospective, 1:1 randomized double-blind active treatment (BackBeat CNT) versus standard medical therapy trial, Moderato II. The study will enroll patients with uncontrolled blood pressure (office systolic > 140, day and AMB BP > 130 mmHg) treated with at least one anti-hypertension medication that are indicated for a dual-chamber pacemaker. The primary efficacy endpoint of the first cohort of the study is the comparison of the mean reduction in 24-hour systolic ambulatory blood pressure following 6 months of therapy between the treatment and the control. Primary safety endpoint is the rate of major adverse cardiac event (MACE) at 6 months between the treatment and control. The company is expecting results on the first cohort of patients in 2019.

SOURCE

https://www.dicardiology.com/content/backbeat-cardiac-neuromodulation-therapy-reduces-blood-pressure-two-years?eid=333021707&bid=2258792

Read Full Post »

The Convergence of Medical Devices & Drugs: Advances in Drug Delivery May 3, 2018 12:00 PM – 5:00 PM, Westin Hotel, Waltham, MA

Posted in Conference Coverage with Social Media, Drug Carrier Design, Drug Delivery Platform Technology, Medical Devices R&D Investment, Medication Remote Compliance Monitoring on April 5, 2018| Leave a Comment »

The Convergence of Medical Devices & Drugs: Advances in Drug Delivery May 3, 2018 12:00 PM – 5:00 PM, Westin Hotel, Waltham, MA

Reporter: Aviva Lev-Ari, PhD, RN

Westin Waltham Boston

70 3rd Avenue Waltham MA US 02451

Venue Website Get Directions

LPBI Group will cover the event in Real Time

@pharma_BI

@AVIVA1950

Aviva Lev-Ari, PhD, RN will be in attendance

MassBio’s second annual Medical Device Event will focus on opportunities and advances in drug delivery, including the unique developmental and regulatory challenges these products face, the many scientific advances in the space and new opportunities for funding. Panelists will discuss innovation and commercialization strategies.

Advances in drug delivery technologies are improving the safety and efficacy of new and existing therapies. The success of many new therapies in development is contingent on the development of effective delivery systems. Traditional drug delivery methods won’t work for some compounds and biologics. Stability issues create challenges for storage and transport. There are opportunities for combination drug delivery products to extend the patent life of drugs on the market. From diffusion based polymer systems to complex delivery devices utilizing diagnostic sensors and sophisticated control systems for precise and timely delivery of life-saving agents, a diverse set of scientific and engineering disciplines are being brought to bear within this space. However, combination products involve components that would normally be developed under different types of regulations, design criteria, and controls. This symposium will explore many of the diverse aspects impacting drug delivery products.

This event will feature an active exhibit hall, panel discussions, a keynote speaker and networking sessions. This is an excellent opportunity for companies to reach a diverse audience that represents nearly every aspect of the life sciences industry, including academic researchers, entrepreneurs, device engineers and biopharma executives.

Clinicians will discuss the medical challenges for which drug delivery innovations have provided a unique solution. Academic researchers will discuss scientific advances which may lead to breakthrough products. Entrepreneurs will discuss strategies for funding new product ventures, and development issues specific to drug delivery products. Corporate speakers will discuss the challenges across the value chain of manufacturing and selling combination products globally. Regulatory speakers will address current thinking and approaches to drug delivery products within government agencies, both US and internationally.

SOURCE

https://www.massbio.org/events/the-convergence-of-medical-devices-and-drugs-advances-in-drug-delivery-2624?utm_campaign=med-device-18&utm_medium=email&utm_source=email-signature&utm_content=&utm_term=

Registration

12:00 pm – 12:30 pm

Opening Remarks

12:30 pm – 12:45 pm

Keynote Presentation

12:45 pm – 1:15 pm

Innovation & Development Panel

1:30 pm – 2:45 pm

Networking Break

2:45 pm – 3:15 pm

Commercialization Pathways Panel

3:15 pm – 4:30 pm

Networking Reception

4:30 pm – 5:30 pm

Speakers

Bob Coughlin, President & CEO, MassBio

Keynote Speaker: Michael J. Cima, Ph.D., Associate Dean of Innovation, MIT

Intraperiotneal Chemotherapy needed to remove the few cells left after surgery _ delivery of drugs to a single compartment
Hyperthermic Intraperiotneal Chemotherapy
Tumor burden – stage 3 women ovarian cancer
Extended IP drug exposure
device for drug delivery to the bladder (cancer): Inflammatory bladder disease, overactive Bladder, bladder (cancer); bladder removal (radical cystectomy – residual tumor size 3 cm tumor)
Local Drug delivery for stone disease in ureter
Change the pharmacology and change the lesion in the bladder – lesion disappeared in a single compartment
Mutation burden in Brain Cancer and in Ovarian Cancer much smaller than in Lung cancer
local drug delivery to one location in the brain and the drug will be carried to the entire body – pathology of the brain leads to different disease related to the Human Brain. Treatment of hemorrhage
Cervical cancer under MRI deliver drug to the tumor hypoxy of the tumor, guide the drug dosage using imaging MRI is Radiation therapy not drug therapy

PANEL 1: Product Development: Drug-Device Technology moderated by Kristina Bieker-Brady, Ph.D., Partner, McDermott Will & Emery LLP

Basic research to clinical development: Drug delivery System

Benjamin S. Bleier, MD, FACS, FARS, Associate Professor, Director of Endoscopic Skull Base Surgery, Co-Director Center for Thyroid Eye Disease and Orbital Surgery, Massachusetts Eye and Ear Infirmary, Harvard Medical School

BBB – Invasive, Non-invasive, Drug modification
Platform technology , Enabling technology to pass BBB Scalable technology: SAfe
Nasal bleed
Nasal Cavity – ENTRY point to the brain use vascularized tissue
nasal mucosa more permeable that any other tissue – diffuse drugs into the brain
Autologous tissue – Nasal Mucosa: Proteins Oligonucleotides,

Maria Palasis, President and CEO, 480 Biomedical, Inc.
Maria Berkman, MD, MBA, Director and Head of MedTech practice, Broadview Ventures
Evan Sherr

Brent Buchine, Ph.D., Co-Founder and CTO, Windgap Medical, Inc.

PANEL 2: Commercialization Challenges

Moderator: Harry Glorikian, General Partner, New Ventures Funds

Paul Just, PharmD, Senior Principal, Medical Device Health Economics, ICON plc

VALUE (outcome achieved per $) is the currency for market ACCESS knock down barriers Care COST
Physician choose product that they wish to use while providing therapy as the lowest cost
Assessing Differentiating Value and Reimbursement
No guidance for combination products: New method of treating patients: Drug-Device
Value: Who benefits from the Value – Target stakeholders: 90 days vs 18-24 month, long term value

Pamela J. Weagraff, Director, MedTech Regulatory, IQVIA [Quantile merged IMS]

MedTech meet BioPharma
Clinical data requirements for medical devices on the increase but not not necessarily in many cases
Combination Products: Microfluidics, micronization – not chemistry but features of the drug delivery device
Option 1,2,3 for Combination Product Pathways: Draft Guidance –>> FINAL immediately in effect

Jessica Ballinger, Chief Operating Officer, Lyndra

Lyndra’s Ultra-long drug release – Extended Release Oral Capsule: 7 days
Dosage Form – Safety
Drug delivery – material manufacturing for long term resident inside the human body
Candidates: AD, Diabetes
Encapsulation automated – 3 partners assembly in several int’l locations in the supply chain: complications in making tablets – three years before the launch, freeze design 1st generation, 2nd generation

Steven Rosenberg, Otsuka Pharmaceutical

Read Full Post »

Skin Regeneration Therapy One of First Tissue Engineering Products Evaluated by FDA

Posted in 21st Century Cures Act, FDA, FDA Regulatory Affairs, FDA, CE Mark & Global Regulatory Affairs: process management and strategic planning - GCP, GLP, ISO 14155, Tissue Engineering and Regenerative Medicine, tagged Cell therapy, FDA approval, RMAT designation, Skin Regeneration, StrataGraft, Tissue engineering on January 8, 2018| Leave a Comment »

Skin Regeneration Therapy One of First Tissue Engineering Products Evaluated by FDA

Reporter: Irina Robu, PhD

Under the provisions of 21^st Century Cures Act the U.S. Food and Drug Administration approved StrataGraft regenerative skin tissue as the first product designated as a Regenerative Medicine Advanced Therapy (RMAT) produced by Mallinckrodt Pharmaceuticals. StrataGraft is shaped using unmodified NIKS cells grown under standard operating procedures since the continuous NIKS skin cell line has been thoroughly characterized. StrataGraft products are virus-free, non-tumorigenic, and offer batch-to-batch genetic consistency.

Passed in 2016, the 21^st Century act allows FDA to grant accelerated review approval to products which meet an RMAT designation. The RMAT designation includes debates of whether priority review and/or accelerated approval would be suitable based on intermediate endpoints that would be reasonably likely to predict long-term clinical benefit.

The designation includes products

defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products;
intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and
preliminary clinical evidence indicates the drug has the potential to address unmet medical needs for such disease or condition.

According to Steven Romano, M.D., Chief Scientific Officer and Executive Vice President, Mallinckrodt “We are very pleased the FDA has determined StrataGraft meets the criteria for RMAT designation, as this offers the possibility of priority review and/or accelerated approval. The company tissue-based therapy is under evaluation in a Phase 3 trial to assess its efficacy and safety in the advancement of autologous skin regeneration of complex skin defects due to thermal burns that contain intact dermal elements.

SOURCE

https://www.rdmag.com/news/2017/07/skin-regeneration-therapy-one-first-be-evaluated-fda

Read Full Post »

Mapping Medical Device Startups Across The Globe per Funding Criteria

Posted in Global Market of Medical Devices Technology, Global Partnering & Biotech Investment, Medical Devices R&D Investment on May 10, 2017| Leave a Comment »

Mapping Medical Device Startups Across The Globe per Funding Criteria

Reporter: Aviva Lev-Ari, PhD, RN

The Funding Criteria is explain in the Image Source.

Med-Tech Planet: Mapping Medical Device Startups Across The Globe

IMAGE SOURCE

https://www.cbinsights.com/blog/medical-device-most-well-funded-startups-global-map/?utm_source=CB+Insights+Newsletter&utm_campaign=63eed75a5f-WedNL_5_3_2017&utm_medium=email&utm_term=0_9dc0513989-63eed75a5f-87377285

Most Well-Funded Medical Device Companies Across the Globe

IMAGE SOURCE

21st Century Cures Act reforms to the Food and Drug Administration’s (FDA) regulation of the medical device and pharmaceutical industries – Medical Device Overview: Major FDA Reform Bill Becomes Law

Posted in 21st Century Cures Act, FDA Regulatory Affairs, FDA, CE Mark & Global Regulatory Affairs: process management and strategic planning - GCP, GLP, ISO 14155, Medical Devices R&D Investment, tagged Breakthrough Devices, Clarifying Medical Software Regulation, Class 1 and Class II Devices, Classification Panels, Cleaning Instructions and Validation Data Requirement, CLIA Waiver Improvements, Humanitarian Device Exemption (HDE), Institutional Review Board Flexibility, Least Burdensome Device Review on December 19, 2016| Leave a Comment »

21st Century Cures Act reforms to the Food and Drug Administration’s (FDA) regulation of the medical device and pharmaceutical industries – Medical Device Overview: Major FDA Reform Bill Becomes Law

Reporter: Aviva Lev-Ari, PhD, RN

HIGHLIGHTS

The 21st Century Cures Act seeks to expedite development of, and provide priority review for, “breakthrough” devices
The act requires FDA to provide training on the meaning and implementation of the least burdensome review standard, and requires an audit of the results
The act expressly excludes certain categories of medical software from FDA regulation

Major provisions of the act related to medical device regulation found in Subtitle F are listed, below.

President Obama recently signed the 996-page 21st Century Cures Act to implement a variety of reforms to the Food and Drug Administration’s (FDA) regulation of the medical device and pharmaceutical industries.

This alert summarizes the major provisions of the act related to medical device regulation found in Subtitle F.

Section 3051 – Breakthrough Devices

Section 3052 – Humanitarian Device Exemption (HDE)

Section 3053 – Recognition of Standards

Section 3054 – Certain Class 1 and Class II Devices

Section 3055 – Classification Panels

Section 3056 – Institutional Review Board Flexibility

Section 3057 – CLIA Waiver Improvements

Section 3058 – Least Burdensome Device Review

Section 3059 – Cleaning Instructions and Validation Data Requirement

Section 3060 – Clarifying Medical Software Regulation

A copy of the act can be found here.

http://docs.house.gov/billsthisweek/20161128/CPRT-114-HPRT-RU00-SAHR34.pdf

For more information, please contact the Barnes & Thornburg LLP attorney with whom you work or one of the following attorneys in the firm’s Food, Drug & Device Group: Lynn Tyler at (317) 231-7392 or lynn.tyler@btlaw.com; Beth Davis at (404) 264-4025 or beth.davis@btlaw.com; or Alicia Raines Barr at (317) 231-7398 or alicia.rainesbarr@btlaw.com.

Visit us online at www.btlaw.com/food-drug-and-device-law-practices.

SOURCE

http://www.btlaw.com/files/Uploads/Documents/2016%20Alerts/Food,%20Drug%20and%20Device/FDA%20Alert%20-%2021st%20Century%20Cures%20Act.pdf

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM393978.pdf