How 3D printing can help babies with Flat Head Syndrome

3D printing applications in the medical sector has impressed many around the world and been adopted by many hospitals and physicians. One of the many reasons of this widespread adoption is due to the technology’s ability to develop customized products from body to the exact specifications of the patient.

Source: 3dprint.com

Here is another case where 3D printing comes in handy: “CranioCaps” to treat a condition in infants’ known as Flat Head Syndrome – “a condition that occurs when a baby positions his or her head the same way repeatedly; this positioning can either occur on the side or the back of the head, and over time the pressure on that part of the head flattens it”. The American Academy of Pediatrics launched a campaign in 1992 called “Back to Sleep” in order to raise awareness about infants sleeping on their backs to prevent Sudden Infant Death Syndrome (SIDS). One way to avoid this is with the use of helmets known as “CranioCaps” for the babies to wear during a 14-week growth period.

St. Paul, Minnesota’s Gillette Children’s Specialty Healthcare luckily had Stratasys 3D printer to print their own CranioCap. It took 5 hours overall: three hours to make the replica of the baby’s head and two to make the CranioCap. Gillette Children’s Specialty Healthcare reports that it treats around 1,100 children with Flat Head Syndrome annually – proving that the printer will definitely be a welcomed addition at the hospital.

3 Biggest Challenges to Healthcare Innovators

          Medtech companies are used to running into regulatory obstacles during their innovation processes. According to MDDI, these companies are divided into three type of business: large scale medical device innovators and manufacturers; new device innovators (ranging from the surgeon with a good idea to the existing medical device company with a product line of a few products); software technology innovators. It’s true that they all share common challenges, but their primary ones are different according to their role in this complex industry.

Source: MDDI

When talking with each segment; here are the three biggest challenges they all share:

1. Cost and complexity to improve and enhance innovation: large scale medical device innovators have a great overview of the marketplace and the regulatory system, but identifying the best R&D opportunities is not always easy. Big data analytics are expensive and complex to implement. “The more incremental the deployment of any new technology can be made, the more likely you are to achieve final success.”

2. Time and volume of follow-up and tracking data from FDA: it’s very time-consuming to go through FDA notices, recalls and regulatory changes. “Technology now allows you to both take optimal advantage of the level of effort required and increase the quality of the results for you by automating the access to the data.”  

3. “Getting blindsided by regulatory issues is probably the most common complaint from software innovators”. Having access to FDA guidance, regulations and industry best practices can help these innovators avoid this type of problem.

Computer simulation on biomedical products: a true possibility?

Computer simulation is broadly used during the development of several critical products such as civil aircraft or nuclear power plants. However, the healthcare industry still mainly rely on long and complex experiments in vitro, on animals, and then on patients, which causes a deep cost pressure – investment that could be used on innovation. The technical term is ‘in silico clinical trials’, which refers to: “The use of individualised computer simulation in the development or regulatory evaluation of a medicinal product, medical device, or medical intervention.”

According to researchgate, Avicenna Action, funded by the European Commission, has engaged 525 experts from 35 countries, including 22 of the 28 members of the European Union, in an 18-month consensus process, to produce this research and technological development roadmap. Providing an overview of where in silico clinical trials technologies are already used; where else they could be used; highlighting barriers that prevent wider adoption.

Research funding agencies, stakeholders, private companies, the academy, the government itself with its regulatory bodies across the world should embrace innovation and write a framework of standards and protocols required to meet safety and efficacy for this type of technology. The European Commission is certainly taking the first step towards a broad conversation inviting experts for several different countries to the table.

Brazil’s trend on the healthcare industry

While ABIMO (Brazilian Healthcare, Medical and Dental Equipment Industry Association) doesn’t have the final numbers of the Brazilian healthcare industry for 2015, we can analyze the sector’s trend until the previous year. The industry of medical and dental equipment grew by 9.1%, in comparison to 2013; while the job market grew by 2.3%.

Source: European Medical Device Technology

Due to Brazil’s large population and increase spending on healthcare, the country’s imports on medical devices passed the US$ 1 billion mark. The exports, however, reached US$70 million only. The United States is both the main origin of imports and destination of exports. Followed by Germany, China and Japan in the origin side and Argentina, Mexico and Belgium on the destination side. There’s a huge gap on the sector’s average revenue per unit between imports (US$ 114.99) and exports (US$33.04) - which makes the trade balance even worse.

The bottom line is that Brazil continues to be a great buyer of healthcare products due to its inability to meet its own demand. On the other hand, the country can be a great source of exports due to competitive prices, strong regulatory and intellectual property system.

Trend report: Top 10 Medical Device Technologies Market by Type

Research and Markets has announced the release of their new report called "Top 10 Medical Device Technologies Market by Type (IVD, Cardiology, Diagnostic Imaging, Orthopedics, Ophthalmology, Endoscopy, Diabetes Care, Wound Management, Kidney/Dialysis, and Anesthesia & Respiratory Care Devices) - Global Forecast to 2020".

These global top medical device markets are expected to reach more than USD 400 million by 2020, growing at a CAGR of 5.5% during 2015 to 2020. The trend is mostly driven by the rising incidence of chronic diseases and increase in disability-adjusted life years (DALYs), technological advancements in medical devices, and growing aging population.

In this report, the top 10 medical device markets are segmented by type and region: in vitro diagnostics (IVD) devices, cardiology devices, diagnostic imaging devices, orthopedic devices, ophthalmology devices, endoscopy devices, diabetes care devices, wound management devices, kidney/dialysis devices, and anesthesia & respiratory care devices.

In 2014, North America was responsible for the largest share of the market, followed by Europe, Asia-Pacific, Latin America, and the Middle East & Africa.  The U.S. is a major market due to the “easy access to advanced medical devices through well-established distribution channels, high patient awareness on medical device technologies, and presence of advanced healthcare infrastructure”. Asia-Pacific is the fastest-growing region because of “the large population and rising healthcare needs, increased spending capabilities of consumers on healthcare, improving healthcare infrastructure in the region, and increasing investments by leading players and respective government agencies”.