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A model for device development

Researchers at the Stanford University Program in Biodesign have completed a one-year study that examined how medical technology is brought to market, approved for use, and enhanced over time. First results of this work were presented at an FDA/Industry meeting organized by the Institute for Health Technology Studies (InHealth) which funded the study, and at a workshop presented at MD&M East in June. This article reports on the presentations given by the Stanford team members John Linehan and Jan Pietzsch. The full study results will published later this year in a scientific journal.

#device development #medical devices #medical products

Crack the Clinical Evaluation Report Enigma

The clinical evaluation report (CER) increasingly has become a key topic in the medical device regulatory world, particularly given the scandals including Poly Implant Prostheses’ (PIP) use of cheaper, industrial-grade silicone in breast implants, toxic debris from metal-on-metal hip implants and transvaginal mesh causing tissue erosion. Following these scandals, CERs have been thrust into the public eye and, as a result, now are coming under increased scrutiny. The 2007 amendment to the European Union’s Medical Device Directive (MDD) resulted in every medical device sold into Europe requiring an up-to-date CER as part of its technical file. This did little, however, to clarify issues surrounding standards and compliance. Confusion remains as to what a CER should contain, how to set it out and what the standard for clinical data should be.

#Clinical Evaluation Report #Clinical Evaluation #medical devices

3-D Printing: A Solution Or The Solution?

3-D printing has, in recent years, been called a “solution” in the true sense of the word. A solution to a whole host of problems, including customization, manufacturing costs, manufacturability and world peace. Well, that last one was an exaggeration—but the way 3-D printing is discussed, one might think it was true. But for all its worshippers—and detractors—3-D printing is neither the answer to all of life’s problems nor a flash in the pan. The technology has been around for decades, and like every other technology, has been improving and growing with time.

#3-d printing

Top Global Medical Device Companies

By now, the medical device industry has had ample time to adjust to its “new normal.” Healthcare firms have had years, really, to revamp their business models to jumpstart growth, but progress has been tortoise-like—hampered by lingering Affordable Care Act uncertainty, new federal regulations, hospital consolidations, purchasing decision instability, fickle reimbursement rates and demands for values-based solutions. Nevertheless, medtech manufacturers realize that future profits depend on their ability to evolve with the market, and many have begun their metamorphoses, whether it be through acquisition (Medtronic-Covidien, Zimmer-Biomet, Smith & Nephew-ArthroCare, Danaher-Nobel Biocare), partnerships (Novartis-Google[x]), restructuring (Philips N.V., Baxter International and Abbott Laboratories) or redefining innovation. As St. Jude Medical Inc. CEO Daniel J. Starks noted, “Innovation is broader than delivering the next breakthrough product. It is about partnering with physicians, hospitals, payers, patients and our communities to challenge conventional thinking and create medical solutions that save and improve millions of lives worldwide—while reducing healthcare costs for all.”

#medical devices

First International Clinical Engineering (CE) and Health Technology Management (HTM) Congress (ICEHTMC)

Key health technology (HT) leaders in Peoples Republic of China (PRC) are planning the First International ICEHTMC in October 2015 in China to identify and address common global healthcare technology issues that are important for both local and global stakeholders. The ICEHTMC approach will incorporate faculty of decision-maker leaders from clinicians, administrators, clinical engineers, and industry. In addition, Clinical engineers (CE) will address the questions of how PRC and other countries can build and or enable the use of proper “smart, digital” hospitals in coming years that improve quality, safety, and care delivery.

#clinical engineer #clinical engineering

Agile Project Management Picture a start-up technology business, where the founders are trying to carve out a sustainable business niche. The sector is changing fast, and they must quickly develop a service that users are prepared to pay for. This is tricky! They can only find out so much through market research, so they need to experiment. This means trying a variety of different offerings. Step-by-step, they need to learn from these and try improved offerings until they develop a solution that really works. You can probably see that many work-related projects – particularly those involving complex, fast-moving situations – resemble this scenario. You can be working towards one deliverable or solving one problem, but then need to change course and revise your plans.

#coach #regulatory affairs #project management #agile

The OSKAR Coaching Framework

The OSKAR coaching framework is one of the most popular solutions-focused coaching models used by organizations. It was developed by coaches Mark McKergow and Paul Z. Jackson and published in their 2002 book, "The Solutions Focus: Making Coaching and Change SIMPLE."

It's a coaching framework you can use within your team or organization, to help you focus on a problem's solution, rather than on the problem itself. You can use it to address specific performance or behavioral problems within your team, such as the one highlighted at the start of this article.

OSKAR stands for Outcome, Scale, Know-how, Affirm + Action, and Review. Here are some practical suggestions for making each of those stages work for you.

#coach

What is Coaching?

You've probably heard people talking about coaching in the workplace. You might have even received some coaching in the past, or you might have used coaching to improve a person's performance, even if you didn't actually describe it as "coaching" at the time.

But what actually is coaching, and how do you use it? And what skills do you need to be an effective coach?

In this article, we'll look at the basics of coaching in the workplace. We'll clarify what it involves, and review the key approaches that you can use to be a successful coach. We'll also review some situations where coaching can be useful, and look at some examples of coaching questions.

#coach

Ricardo Feliz - Uma loja de brinquedos que vende felicidade

Ricardo era um médico pediatra, que tinha seu consultório, até que seu único imóvel foi desocupado e uma sequência de fatos o levou a abrir uma loja de brinquedos. "Afinal, pediatra entende de criança", conta. "Faça sempre do seu jeito!". Mesmo sofrendo com prejuízos constantes, e sabendo que não poderia construir uma grande empresa simplesmente copiando cases bem sucedidos, ele criou uma cultura vencedora de prestação de serviços e comunicação com seus colaboradores, e transformou a RiHappy em uma das maiores redes varejistas de brinquedos do país. Inspire-se com a história de persistência e autoconhecimento de Ricardo Sayon!

China's Investment Outlook and Opportunities

VC and PE funds have been proliferating in China as both domestic and global players set their sights on the country's booming digital and middle class consumers. But are too many funds chasing too few good opportunities? Where are the most promising investment opportunities and why? Hany Nada of GGV Capital, Fang Fang, of JP Morgan Investment Banking, Xu Xiaoping of ZhenFund, and Hans Tung (BS '93) of Qiming Ventures gathered together at the 2012 China 2.0 Conference to share their insights. The session was moderated by David Chao (MBA '93) of DCM.

#china #investment

Em nosso post anterior, apresentamos alguns dos modelos de impressora 3D desktop mais bacanas no mercado. O detalhe é que só mostramos um tipo de impressão: as de extrusão de plástico. Existem pessoas e empresas trabalhando para criar outras maneiras de tornar o seu modelo virtual em um objeto real. Conheça hoje outra tecnologia de [...]

#estereolitografia #3dprinting

Um dos eventos mais legais que acontece no Brasil sobre tecnologia e cultura digital é, sem dúvida nenhuma, o InterCon do iMasters. Ano passado o evento completou 10 anos de existência e para comemorar seu aniversário resolvemos fazer uma edição noturna do InterCon. Tema que pode estar bem presente no iMasters em 2014, o Movimento Maker e Open Hardware.

#open hardware #arduino

What is regulatory science? And what does it mean to you? Watch and learn at FDA Voice. For more information on regulatory science, see:

Why You Should Care About Regulatory Science

http://go.usa.gov/r6HT

Personalized Medicine Will Fit You Like a Glove

http://go.usa.gov/YuJG

FDA Targets Drug Side Effects

http://go.usa.gov/YuJz

Emerging Technology Embraces the Future

http://go.usa.gov/YhmT

Scientists Working to Keep Foods Safe

http://go.usa.gov/YuSR

#fda #regulatory affairs #medical devices

Do you have sleep apnea and use a continuous positive airway pressure (CPAP) device when sleeping? Here are some tips from the U.S. Food and Drug Administration (FDA) on how to safely and effectively use your CPAP device.

#CPAP #medical devices #fda #sleep apnea

Eric Topol says we'll soon use our smartphones to monitor our vital signs and chronic conditions. At TEDMED, he highlights several of the most important wireless devices in medicine's future -- all helping to keep more of us out of hospital beds.

Accepting his 2005 TED Prize, inventor Robert Fischell makes three wishes: redesigning a portable device that treats migraines, finding new cures for clinical depression and reforming the medical malpractice system.

Argentine-Spanish entrepreneur Martin Varsavsky has founded seven companies over the past 20 years. These include telecoms provider Viatel and, more recently, fon.com, which aims to create a global community of wifi users. Ecuadorian Carlos Moncayo and his two brothers founded Asiam, a Shanghai-based offshore manufacturing management company that specialises in clothing, in 2003. The company now ships more than $34m worth of clothing per year. Mr Moncayo was voted Asia's Best Young Entrepreneur by Businessweek magazine in 2009.

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