Category Archives: Business

03May/17
Insanity Image

White Paper: Is Innovation Without Transformation Insanity?

By: Ellyn McMullin, Research Asssociate and Daniel R. Matlis, President

Are You Transforming Your Business or Merely Digitizing Process?

To fast-track the transformation of ideas into innovative products, pharma and biotech companies need to be open to new ideas and aware of new systems and technologies. Simply digitizing existing processes is accelerated insanity!

The costs of bringing a new drug to market is high, especially when you factor in the many candidates that do not make it. In this white paper, Axendia suggests an approach that will consistently create and deliver high quality products to market while reducing cost and improving ROI in today’s competitive marketplace.

Today’s challenge is not the availability of the technology but the rather the need for vision and leadership, knowhow and discipline to drive transformation.

Download this free white paper to learn now.

13Mar/17
CyberSecurity

CYBERSECURITY RISKS IN MEDICAL DEVICES ARE REAL

By: Eric M. Luyer, Market Research Analyst 

The Healthcare Industry Has a New Set of Threats on Its Hands

PPP_IGLOB_CLP_Global_Computer_Network_Red_Color_Pencil_HEXConnected medical devices-like other computer systems-can be vulnerable to security breaches and have a potential major impact on safety and effectiveness of the device.  Specifically, in a healthcare environment, this vulnerability increases asmedical devices and medical equipment are becoming more connected through the internet to other medical devices, patients and/or to hospital networks (also referred to as the Internet of Medical Things).

To address the cybersecurity threat, in December 2016 FDA issued Guidance on Postmarket Management of Cybersecurity in Medical Devices.

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24Feb/17
wp image biovia

Data Integrity White Paper Alert

FreeAnalystWP

TURN YOUR DATA INTO KNOWLEDGE

Sound data is the foundation to good decisions and good science.  In the Life-Science industry patient outcomes, product quality, safety and efficacy all rely upon vast amounts of data that is generated throughout the product lifecycle.  This means that patients, brand equity and reputations have the potential to suffer greatly without a strong data integrity foundation.

What is Data Integrity?

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25Jan/17
wakup call

Rapid Regulatory Changes Will Impact Medical Devices and Diagnostics Industry

By: Hugo Felix, Director Design Quality Assurance, Bard Access Systems

This is Your Wake Up Call!

The Medical Device and Diagnostics Industry is experiencing rapid regulatory changes.  To deal with these changes there are certain key areas that need to be addressed so we can thrive, rather than just survive.  Quality Systems need to account for that, deal with the rapid pace and help us manage it.

New standards, regulations and guidances will have a significant impact in our industry:

  • The International Organization for Standardization (ISO) published ISO 13485:2016.  This represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices
  • ISO 13485:2016 has a 3 year transition period and no new accreditations to the 2003 version after year 2
  • TC210 just approved changes to ISO 14971, Application of Risk Management to Medical Devices and an update to the accompanying ISO TR 24971 and a new TR for Post Market Surveillance

For its part, the US FDA issued guidances late last year on Benefit Risk Analysis for Pre and Post Market and draft guidances for deciding when to submit a 510K for device changes and another for software changes. MDD/IVDD to MDR/IVDR change is slated for May 2017 with full implementation deadlines of 2020 for MDR and 2022 for IVDR.

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