3D printing helps high-risk surgery in Brazil

China and the west have been constantly showing us how 3D printing makes life-threatening and complex procedures much safer. However, this is happening elsewhere too. A team of surgeons in Blumenau, South of Brazil, has used 3D printed medical models to increase the probability of success of a surgery on a six-year-old girl suffering from orbital hypertelorism.

3ders.org

It was a complex and high-risk operation because the doctors were forced to work in an area close to lots of vital organs and blood vessels. The team therefore decided to develop a 3D printed model of the girl’s skull in order to prepare for the surgery. The replica was also at hand during procedure and definitely contributed to the six-hour surgery’s success. One of the doctors explains. ‘After spending some hours studying the 3D printed skull, we practiced the crucial bone incisions on it and also used it as reference during the actual surgical procedure. Having a model to manipulate, as an addition to the imaging exams, was very important for the success of the final result.’

The surgeons were very satisfied with the 3D printing model and have already ordered the next one for a forthcoming spine reconstruction surgery, which will give the patient a few extra centimeters in height.

“MRI images and CT scans were used to make this medical model, which took 57 hours to 3D print. Finishing work to ensure complete accuracy took another 16 hours, and all the work was outsourced to the Brazilian-based 3D printing service bk3D. According to the company’s managing partner, this is just one of the ways in which 3D printing can be used to improve medical practices. ‘There are numerous possibilities for 3D printing to aid healthcare, from surgical procedure planning to the replacement of entire bioprinted organs. We still have a long way to go, but it is already possible to enjoy the benefits that engineering offers,’ he said.”

As 3D printing is already being used to save lives, we can only hope it will become common in every hospital around the globe.

How can device makers succeed in today’s transforming healthcare industry?

     The healthcare industry is moving toward an “outcomes-based, patient-centric, cost-conscious environment”. How will this change impact the healthcare manufacturers? What do they have to do to compete successfully, grow market share, and stay profitable? According to MDDI, there are three key factors to surviving in the transformed healthcare ecosystem.

MDDI

1. Get Closer to the Patient, Get Smaller

Labs must extend its range to patients: point-of-care testing (POCT) is moving outside hospitals into the community as we are seeing patients and caregivers becoming more technology-empowered. This is driving demand for products that are: smaller, simpler while maintaining functionality and accuracy. Interfaces must be more intuitive for operators who may have minimal or no training. Device makers must also keep in mind how their equipment will maintain connectivity to the central lab and its data systems.

2. Big Data Analytics, Big Opportunity

Since the volume of healthcare data in increasing, manufacturers of diagnostic devices and lab systems have an opportunity to multiply the value of their products. Incorporating the right analytics can enable a extensive range of value-added competences. “Analytics can be used to streamline and improve processes—supporting better test utilization based on ordering patterns and faster throughput by analyzing workflows, for example. “

3. Business Model Innovation

To thrive in the new healthcare environment, clinical laboratory device makers need to focus their innovation investments on the business models, which will highlight the role of data as a generator of value. “While accuracy, ease of use, and affordability continue to be essential, a key differentiating factor will be how a product manages, distributes, and utilizes data to help improve and accelerate clinical decision-making.”

“Clayton Christensen, author of The Innovator’s Dilemma and The Innovator’s Prescription, has shown that being slow to react to disruptive changes in technology and embrace new market opportunities leads to failure. The dramatic changes impacting the healthcare marketplace are upon us—and the time to move forward is now.”

Get the Most out of Your Medical Device Contract Manufacturer

Contract manufacturing is a term that has been around for decades in the medical device industry. However, medtech companies are increasingly calling these service providers to assume more responsibilities, including design and development. Whether because of pricing pressures, government regulations, or rapidly evolving manufacturing techniques, manufacturers are offering a wider menu and forming business partnerships with medical device companies.

However, every type of outsourcing has its difficulties. There are some tricks to get the most out of it, though.

1. Clearly define roles, responsibilities, and expectations: “For example, what kind of support is the contract manufacturer willing to provide in the early stages? Who will assemble the prototype within each phase? Who will do the testing?”

2. Constant vigilance will minimize surprises: “A lack of communication will inevitably lead to nasty surprises, but “over communicating”—too many e-mails or too many meetings—can negatively affect productivity.”

3. Truly understand the level of each partner’s expertise: “Hope for the best, but plan for the worst.”

4. Fool me once…: “Learn from past mistakes, which often are due to putting off “trivial” issues early on in the process that then turn into much larger problems later on.”

If you are having issues with your medical device contract manufacturer; you are interested in arranging a business partnership or curious to learn more about medical device contract manufacturing, drop us a line! Biokyra is a Biomedical Engineering Company that develops minimally invasive medical devices, from the idea/need to the pre-series production. Our goal is to make your idea become an innovative and successful product. Therefore, we provide feasibility analysis, materials research, validation tests, and many other services.

References: http://www.qmed.com/mpmn/medtechpulse/outsourcing-medical-product-development-right-way

Updates of Medical Device Regulatory System in 5 Major Markets

As the world does not agree on a harmonized medical device regulatory system, manufacturers face different scenarios in terms of market entry, registration requirements and compliance issues to be able to sell their products in foreign countries. Therefore, it’s important to monitor regulatory updates in major markets.

Brazil: ANVISA (Brazilian Health Surveillance Agency) has shown intentions to make market entry less burdensome—both externally for Brazilian market registrants and internally. Early this year, the government passed a new law, which allows ANVISA to do the following:

• Expand validity timeframes for some medical devices by up to 10 years.
• Accept quality management inspection reports conducted by other regulators.
• Expand certifications of laboratories authorized to conduct inspections and postmarket surveillance activities.
• Revamp requirements for registration transfers.

ANVISA must still develop its own regulations to take advantage of the new law. However, the regulator is now fully authorized to streamline the country’s device registration process. ANVISA has also extended its deadlines for technical requirement responses: registrants now have 120 days, rather than 90, to respond to ANVISA inquiries. Brazilian clinical testing rules for medical devices have also been harmonized more closely to those of international standards.

India: Although a comprehensive regulatory system has not yet been implemented, the Indian government has adopted significant actions to launch a more substantial medical device regulation. The government has proposed the creation of a new regulatory body, the National Medical Devices Authority (NMDA), a step towards a more strong regulatory system, which would provide transparency and predictability.

China: Despite recent initiatives towards a more structured and transparency to the registration process, China’s medical device regulatory system remains complicated and expensive. China Food and Drug Administration (CFDA) has formalized and clarified clinical trial requirements for medical devices and even established a process similar to FDA's substantial equivalence that can waive clinical trial requirements for qualifying devices. However, medical device registration fees have increased substantially in 2015. In many cases, it’s more expensive to bring a device to market in China than in the United States.

Japan:  The Pharmaceutical and Medical Device Law (PMDL), which replaced the country’s longstanding Pharmaceutical Affairs Law (PAL) last year, has impacted all aspects of the registration process. PMDL allows Japanese market registrants to utilize third-party certification from Registered Certification Bodies instead of Pharmaceutical and Medical Devices Agency (PMDA) reviews. There is also a new pre consultation program for manufacturers beginning their Japanese registration efforts.

South Korea: The Ministry for Food and Drug Safety (MFDS) has already introduced a new pathway that requires Korean Good Manufacturing Practice (KGMP) certification earlier in the registration process. MFDS has also suggested other changes to be implemented over the next months. The ministry is also planning to regulate in vitro diagnostic devices as medical devices rather than pharmaceutical products, which manufactures will have to ensure compliance under the South Korean Medical Device Act instead of the Pharmaceutical Affairs Act and comply with KGMP. Low-risk device market pathways in South Korea are also scheduled for reform.

References: http://www.mddionline.com/article/global-regulatory-update-2015-07-28-15