Making Global Medical Device Product Innovation A Reality – Watch the Webinar Replay

By Helene

Technically and geographically diverse product development teams must work together more closely than ever to develop medical devices which will focus on the needs of patients and doctors globally. In order for medical device companies to compete, traditional voice of customer (VOC) approaches need to keep pace with healthcare consumers increasingly sophisticated product needs. Medical device product innovation can result from improved ideation which facilitates collaboration between all global stakeholders.

Medical device product development is a complex process involving research and development teams, designers, and the marketing and regulatory teams that gather requirements from customers and governing agencies. A 2012 report from Axendia titled “Walking the Tightrope: Balancing the Risks and Rewards of Med-Tech Globalization” highlights the opportunities and challenges posed by increasing globalization. Medical device product opportunities lie in growing global patient markets and working with outsourced partners in a more collaborative role. Challenges include increasing data visibility and analysis as well as keeping track of regulations for each region.

Smart Watch Design for the Life Sciences Industry

Smart Watch Design for the Life Sciences Industry

Dan Matlis, president of Axendia, was one of three speakers at Dassault Systèmes (3DS) sponsored webinar during the December 3rd (now available on replay) discussing results from this report as well as ways medical device companies can address them. The webinar titled “Learn How Leading Medical Device Organizations are Driving Innovation in a Global Marketplace”  also included Cathi Crist, Partner and leader of the Life Sciences practice at Kalypso where she educated viewers on how product lifecycle management (PLM) facilitates innovation. Rounding out the webinar was Stuart Karten of Karten Design, where he shared his firsthand insights on how leading medical device organizations are leveraging design and innovation to improve and create new products. Click here to watch the webinar replay.

Today’s global consumers develop strong and sometimes very personal reactions about the healthcare products they experience, and are quick to discuss their likes and dislikes via social media. These tweets, Facebook updates, and Instagram posts in turn create more discussion and opinions among their network and beyond. These data create a rich product development resource for medical device companies. Focus groups and surveys have always been used by companies to gauge needs of their customers, but they can be time intensive and expensive. Innovative medical device companies realize that listening to customers first, in real time, rather than being reactionary when complaints arise, will be the winning strategy. Indeed, putting patients and doctors first, and even involving them in the product development process, will result in more customer satisfaction and sales.

The Dassault Systèmes Ideation and Concept Design for Medical Device Industry Solution Experience redefines medical technology workflow via social collaboration. Powered by the 3DEXPERIENCE platform, it is the first cloud-based, all in one innovation management system. This solution was highlighted during the webinar, and in keeping with social collaboration, we hope you can join the discussion, and leave any comments or questions below.

Cross-species organ transplants set to increase

By Catherine

Written by Catherine Bolgar*
Augmented reality heart

Almost 115,000 solid organs were transplanted in 2012, which was less than 10% of global needs, according to the Global Observatory on Donation and Transplantation. In the U.S., 18 people die daily while waiting for an organ transplant.

Xenotransplantation, or transplants from other species, could provide an unlimited supply of organs and cells. Huge strides have been made in this area in the past decade, but challenges remain.

After initially focusing on primates such as baboons and chimpanzees, researchers have turned to pigs, which grow quickly to the appropriate size and which are in abundant supply. However, the human immune system reacts more strongly to pig organs than to human organs.

If you put a human organ into a human with no anti-rejection treatment, it will survive about a week,” says David K. C. Cooper, professor of surgery at the University of Pittsburgh’s Thomas E. Starzl Transplantation Institute. “If you put a pig organ into a human, it will last five to 10 minutes. There’s a much stronger immune response.”

Sugar molecules, called galactose oligosaccharides, on the surface of cells in the pig organ provoke human antibodies into action. So scientists have been genetically modifying pigs to knock out the genes that produce the offending sugar.

That helps, but it isn’t enough. Researchers are trying to delete other genes responsible for major antigens recognized by the human immune system and to add protective human complement-regulatory proteins. Complement proteins are part of the system that destroys cells that the body has identified as being foreign. Differences in how pigs and humans control blood coagulation also is a challenge—too much coagulation and you get thrombosis, not enough and you get bleeding. Now some pigs have been modified to express human anticoagulants. A number of pigs have different combinations of added or deleted genes.

It’s becoming much more precise the way you can genetically modify the pig,” says Peter Cowan, scientist director of the Immunology Research Centre at St. Vincent’s Hospital in Melbourne and president-elect of the International Xenotransplantation Association. “The thing with xenotransplantation that you can’t do with humans is you can keep modifying the donor. You can identify new problems and can keep adapting the pig to the human recipient. In that respect, pig donors might be as good as, if not better, than human donors in the long run.”

Heart valves from ordinary pigs have been used in humans for years, with best results in older patients whose immune systems are less robust. The valves are treated with agents that protect the pig cells, and therefore injury to the cells is slow, Dr. Cooper says.

Some of the biggest hopes are transplants of pancreatic islet cells, which produce insulin. Pig islets transplanted into nonhuman primates have successfully reversed diabetes.

Sixteen humans with Type 1 diabetes received pig islets in a clinical trial in New Zealand, eight in Argentina and eight in Russia, according to Living Cell Technologies, the Australian biotech company conducting the trials. To protect against immune response, the islets were encapsulated. The patients were able to reduce, but not completely stop, their insulin doses.

The World Health Organization estimates that 347 million people worldwide have diabetes. One day, successful transplants of pig islets could let diabetics regulate their insulin levels without the need for insulin injections.

Successful pig organ transplants are farther in the future. Two baboons at the U.S. National Institutes for Health currently have pig hearts transplanted into them. One has been beating for more than a year and the other for more than two years. “That’s a big step forward,” Dr. Cooper says. However, the baboons’ own hearts are still beating alongside. “We are now asking the question of whether, if you replace the baboon heart with a life-supporting pig heart, will you obtain the same result?”

Next in order of difficulty come kidneys, livers and lungs, all of which present coagulation challenges in addition to rejection.

One of the big concerns in using animal donors is the transfer of diseases to humans. The genome of any pig individual is unique, so each pig has a different set of porcine endogenous retroviruses, or PERVs. These PERVs aren’t transmitted by infection, like other viruses, but instead within cells, from mother to child. “This is the inherent risk that pig cells realize,” says Ralf R. Tönjes, head of the “non-vital tissue preparations, xenogenic cell therapeutics” section at the Paul-Ehrlich-Institute in Langen, Germany. “We have the tools and diagnostic techniques to screen the pigs for the presence or absence of infectious PERVs.”

In addition, “all the exogenous germs have to be excluded from any donor pig used for xenotransplantation,” Dr. Tönjes says. “This is the law. Any bacteria, viruses and fungi we know that could be harmful for the recipient have to be excluded by the proper screening program realized by the preclinical breeding facility. We’re talking about bacteria like staphylococcus and viruses like herpes. It’s a real, real effort.”

Pigs offer advantages in terms of germs. “You’re actually less likely to get a virus going from pig to human than from chimpanzee to human because of the distance between the species,” Dr. Cowan says.

The donor pigs can be raised in controlled, clean facilities, and constantly screened for pathogens. With human donors, “in many cases you don’t know what the donor has. There are some viruses that if you just recently got infected won’t show up in tests before an organ is transplanted,” he says. Except for cases where someone is donating a kidney or part of his liver, human donors are dead, and doctors can’t ask about medical conditions.

Working on multiple fronts—genetic modifications to donor pigs, new immunosuppressants and anti-inflammatory drugs—researchers hope to get to a point where transplants from pigs survive as long as transplants from humans.

If we resolve the remaining problems, the impact of xenotransplantation would be immense,” Dr. Cooper says. “Xenotransplantation could offer cures for millions of people world-wide with conditions like diabetes, Parkinson’s or corneal blindness, as well as organ failure.”

*For more from Catherine, contributors from the Economist Intelligence Unit along with industry experts, join The Future Realities discussion.

The International Conference on Harmonisation’s Planned Drug Manufacturing Guideline: What Do Pharma Manufacturers Need To Know?

By Jennifer

International Conference on HarmonisationThe International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is an organization that brings together pharmaceutical regulatory authorities in Europe, Japan, and the United States towards the goal of standardizing processes for safe and effective drug discovery and development. On October 10th, 2014, ICH published an initial concept paper for guidance in its Quality category titled ”Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.” The resulting ICH Q12 guideline, due to be available in 2017, will complement existing quality assurance plan guidance in the pharmaceutical development and launch phases with regulatory recommendations in the later chemistry manufacturing and controls (CMC) phase. Adoption of ICH Q12 will benefit patients, pharmaceutical/ biotech companies, and regulators through continual improvement of post approval processes. So what should you do?

In this article, we will review the concept paper as well as to begin to highlight how the 3DEXPERIENCE Platform and the Licensed to Cure for BioPharma industry solution experience can help you prepare for, and implement the ICH Q12 guidance. We will follow the ICH Q12 updates closely on the blog, see all posts tagged with ICH here.

Licensedd To Cure For BioPharma

Representation of the solution (example).

While ICH Q12 is a very fitting addition to the organization’s Quality guidelines, the concept paper makes it clear that creation of the guideline is due to unforeseen gaps in the implementation of  ICH Q8-Q11, which are as follows:

 

The ICH Q12 guideline is expected to impact the following areas

  • Regulatory Dossier
    • Updates aimed at improving post approval changes
  • Pharmaceutical Quality System (ICH Q10)
    • Develop improved knowledge and change management systems
  • Post-approval Change Management Plans and Protocols
    • Establish criteria for managing and submitting post-approval changes

 

The benefits of ICH Q12 implementation include

  • Improving reliability of the supply of pharmaceuticals through more CMC change management processes
  • More standardized and useful regulatory dossiers
  • Enhance use of regulatory tools for Post-approval Change Management (PACM)
  • Continual improvement of the manufacturing process
  • Reduction of product variability
  • Increased manufacturing efficiency

 

The benefits of product lifecycle management

At Dassault Systèmes (3DS), we have long recognized the benefits of product lifecycle management in improving the drug manufacturing process and ultimately the patient experience. The Licensed to Cure for BioPharma industry solution experience powered by the 3DEXPERIENCE platform combines advances in collaboration, global product development, and information intelligence to provide operational excellence. This single version of the truth, systematic  approach to drug manufacturing fits well with the ICH Q12 vision, and we look forward to working with biotech and pharma manufacturers to guide them in adapting to these changes. You can learn more about 3DS pharma and biotech solutions by attending the 3DEXPERIENCE Forum—North America, taking place November 12-14, 2014 in Las Vegas.

The ICH Q12 guideline will represent a major change as it will be applicable over the lifecycle of the product and focused on the CMC phase. An Expert Working Group (EWG) will be comprised of assessors and inspectors with expertise in quality systems and pharma manufacturing of chemical, biological, or biotechnological products. The EWG will meet in November 2014, June 2014, and November 2015, with the Adoption of Step 2 Document occurring in Q2 of 2016 and Adoption of Step 4 Document occurring Q2 2017 (see this description for details of the ICH process). Although not all regulatory authorities (such as the Food and Drug Administration, (FDA)) adopt the ICH Guidelines directly, ICH Q12 will surely impact regulatory requirements globally.



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