FDA’s initial thoughts on 3D printed medical devices

The U.S. Food and Drug Administration (FDA) has recently released a draft guidance for the 3-D printed medical devices sector. The agency took into consideration inputs from device manufacturers, 3-D printing companies, and academics who testified at a 2014 hearing. According to QMED, the document covers device design, manufacturing, and design testing and for the purposes of the draft, FDA identified four main types of 3-D printing—powder fusion, stereolithography, fused filament fabrication, and liquid-based extrusion.

Source: QMED

3D printed medical device producers would have to “clearly identify every step in the 3-D printing process, and might need to submit a ‘high-level summary of each critical manufacturing process step,’” the guidance says. They would also have to record each step’s risk, and describe how they would lessen those risks. “The type of testing data needed would depend upon whether the device is an implant, load-bearing, and available in standard sizes or custom-made for each patient, or as FDA put it ‘patient-matched.’”

The implications for 3-D printed devices are enormous – therefore the draft guidance is the agency’s initial thoughts on the technical considerations surrounding the design, manufacture and testing of 3-D medical devices, which have few precedents. “While this draft guidance includes manufacturing considerations, it is not intended to comprehensively address all considerations or regulatory requirements to establish a quality system for the manufacturing of your device,” the agency said.

The draft guidance “provides a solid basis for medtech innovators to understand what is needed to prove safety, efficacy, and consistency to growing on-demand components for the human body,” said Derek Mathers, an adjunct professor of 3-D printing at the University of Minnesota and business development manager at Worrell Design in Minneapolis.

     “Standard-sized 3-D printed devices are offered in discrete sizes, and include features that are too complex to be manufactured with traditional processes like machining and molding,” he explained. “Patient-matched 3-D printed devices are devices that are digitally scaled (manually or by using an algorithm) to match a patient’s specific anatomical features. The FDA identifies that these bespoke devices will require significantly more validation work across every step of the ‘scan-to-fit’ design process.”

Artificial intelligence beating humans in detecting illness

    According to a recent report in Kurzweil Accelerating Intelligence, Samsung Medison has updated its RS80A ultrasound-imaging machine with a feature called S-Detect for Breast that analyzes breast lesions. The system uses big data collected from breast-exam cases and suggests whether the lesion is benign or malignant.

Source: QMED

     "We saw a high level of conformity from analyzing and detecting lesion in various cases by using the S-Detect," said professor Han Boo Kyung, a radiologist at Samsung Medical Center. "Users can reduce taking unnecessary biopsies and doctors-in-training will likely have more reliable support in accurately detecting malignant and suspicious lesions."

   Researchers at the Regenstrief Institute and Indiana University School of Informatics have also noticed that computers are better than humans in detecting cancer. According to their research, existing algorithms and open-source, machine-learning tools are as good or even better than human when detecting cancer cases using data from free-text pathology reports. The electronic approach was also faster and used fewer resources than people, according to Regenstreif.

    "We think that it’s no longer necessary for humans to spend time reviewing text reports to determine if cancer is present or not," said author Shaun Grannis, MD, interim center director. "We have come to the point in time that technology can handle this. A human's time is better spent helping other humans by providing them with better clinical care."

Making medical devices that customers want

Major challenges influence how the medtech industry works in term of product management, market positioning, and early-stage design and development. From downward cost pressures, reimbursement and regulatory requirements, increased competition, and, internal pressure to generate sales. As easy as it sounds, a customer-centric approach is a difficult thing to accomplish – but it helps medtech companies to think differently, engage with customers differently, and design and market devices differently. Here’re some tips on how adopt this strategy:

Source: MDDI

* Start with the Right Mindset: being a medical device company means that you are in the business of restoring and improving health. “Recognizing that will help you stay focused on making devices customers want and will buy.”

* Get Customer Input the Right Way: don’t just ask what features customers want in your product – ask what outcomes they want from using your product. “It is not the responsibility of customers to figure out what features will provide the experience they desire or achieve the result they want. What customers can meaningfully talk about is what experience and outcomes they want.”

* Minimum Viability, Maximum Value: “Put in just enough features so you validate that what you’re making is viable. Viable means the lean product sufficiently meets a customer need and will sell”.  In the medical sector, this could be harder due to regulatory approvals, reimbursement issues, and clinical trials. However, this is an attempt to minimize both investment and risk to avoid going to market with an expensive, feature-rich product that bombs. Maximum value is all about how much value your product can provide to customers.

         Despite significant barriers to successfully launch a product, this is an industry that exists to save lives – so companies should stay focused on the value, not product features.

Why medical innovation is so hard

BIOMEDevice Boston conference will happen between April 13-14 and one of the speakers is Bill Betten, director of business solutions at Devicix (Eden Prairie, MN). He recently gave an interview for Qmed about the reasons why medical innovation is so hard to fullfil. “You build around what has been done before. When people hear that statement, they sometimes say things like: ‘what about the implantable pacemaker? Surely that was not incremental?’ But you could argue that the pacemaker certainly built on what came before,” says Betten.

Here are some reasons why leapfrog innovation rarely happens in the medical industry, according to him:

- Financial Constraints: makes it difficult for companies to create breakthrough products or create devices that are less expensive but functionally equivalent to older technology. Due to increasingly cost-conscious hospitals, companies are being forced to reduce costs of their products. “In the past, it was commonplace for device makers to charge substantially more money for new products that only had minor improvements over the previous-generation product. That isn’t the case anymore: many hospitals are now hesitant to invest in new devices that are not demonstrably better than established technologies.”

            Another important point is the vital role of medical device start-ups in developing revolutionary medical technology: one has to add the struggle they go through to obtain venture capital funding for their projects.

- Regulatory Challenges: in a highly regulated industry like the medical sector, product development costs can skyrocket. “Regulatory costs run in the tens of millions of dollars for most 510(k) products, according to a report on AdvaMed’s website. For PMA products, marketing a medical device in the United States can take close to $100 million on average.”

These obstacles are faced by medical start-ups all over the world and Biokyra is no exception. The Brazilian-based company is currently developing medical devices in the vascular area, going through regulatory processes and filing Brazilian and international patents.

Medical Devices & Product Development: following every step

Harshal Shah, vice president of the Global Medical Technology Division at Cambridge Consultants, gave an interview for MD+DI online earlier this month on his insights on FDA approval processes and commercialization strategies for medical devices. As he works closely with medtech companies and innovators, Harshal advises that product developers must identify the category in which the product is going to fall into according to FDA’s guidelines and interact with the agency in the early stages of the development. The FDA has improved drastically and has a well-published process for requesting FDA’s feedback and meeting with some of the key people who are directly involved and relevant to the innovation. He also suggests that these startups and innovators should try to invest and plan out costs for hiring regulatory advisors, as it’s a complex process.

Regarding product development, Harshal explains that innovators should work with Quality by Design and the Design for Manufacturing principles: have specific experts who specialize in Quality by Design principles and QbD audits and Design for Manufacturing audits of design work. So, one can make changes early on and produce prototypes as well as the clinical trial devices in line with what will be able to produce for commercial scale in the future, after approval

“My deep expertise is more towards the late end of the development cycle when you’re preparing for your trials and approvals. Even before you think about producing your trial size batches for your new product, it’s really a must to get a good understanding of how you’re planning to get this product into the commercial market.”

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.