For a longtime, the biggest issues in manufacturing a medical device were the safety of the patient, improvement in their condition and quality of life, and whether or not the device functioned properly.
A number of physical factors affected this, including material and the latest technology, but overall the goal and the obstacles to surpass in reaching it remained the same. Now there’s a major issue that’s complicated medical matters more so.
Connectivity and the Internet’s role in medical devices and healthcare systems may help providers and patients be more proactive in addressing health concerns, whether they be minor or severe.
However, technology, connectivity, and the rapid pace at which these factors are changing the medical device and health care industry, may be compromising security and safety.
Now the FDA is stepping in to offer new guidance for medical device manufacturers as they designing and developing safer connected products and systems.
Image Source: Wikimedia
Guidance To Improve Safety And Mitigate Risk
The FDA is taking action over concerns that medical devices, which exchange data and information on a patients health, are made to function safely, accurately, and securely.
With the recent release of new draft guidance, the FDA is hoping to address issues with healthcare industry cybersecurity, device interoperability, and additional risks that are present when technicians, system integrators, and other third parties must be involved in making devices and systems operable.
The agency is also seeking to help manufacturers avoid errors and inconsistencies that could result in inaccurate measurements, disfunction, mislabeling and misinformation that might result in patient harm or even death.
Image Source: Wikimedia
Catching Up With The Technology We Create
With the pace of technology and the potential it has for saving and bettering lives, it appears that we still have some catching up to do when it comes to safe and reliable integration of advanced medical devices.
Will the new FDA guidance help make things easier for manufacturers and improve safety and security for patients and health care providers?
Medical Device Manufacturers Use Robots For Speed, Safety, And Cleanliness
Robotic equipment in medical device production lines allows companies to maintain high standards of cleanliness, worker safety, product consistency, and speed. From heart valves to artificial joints to surgical equipment, robots increasingly play an integral role in medical device manufacturing.
Robots Limit Biological Contamination
Manufacturing facilities have long contended with the contamination issues introduced by human workers. Robots allow for the removal of the human element from many production areas. In addition to maintaining sanitary environments, robotic installations have aided manufacturers during the coronavirus pandemic. The CEO of MICRO said that greater integration of robots in workflows helped to limit human-to-human contact among workers.
Precise And Consistent Results
On top of sanitation, medical devices require high degrees of precision. Robots are capable of extreme dexterity that a human worker cannot replicate with consistency. Medical device companies draw upon the robotic developments pioneered by the electronic and automotive industry that turned to robots to build miniature components. New production processes for building artificial heart valves have incorporated small robots that perform highly detailed work on small parts with repeatable accuracy.
Elimination Of Workplace Sharps Hazards
A multitude of medical devices and tools involve very sharp edges. Fabrication of these instruments historically exposed workers to the risk of serious cuts. The installation of robots to grind, deburr, and package medical sharps reduces risks of worker injury. Workers focus instead on monitoring operations while robots produce precision goods at speeds beyond what human workers could achieve.
Robots Aid Industry Expansion
Tecomet Inc. in Boulder, Colorado, is in the middle of expanding operations. In addition to hiring more workers, the company will add another 25 machines, including robotic systems, to its new facility. Longer-term, the company anticipates that it will manufacture robots for clients operating cleanroom facilities at hospitals.
In your experience, how has robotic equipment overcome production challenges or expanded opportunities for new business?
ABOUT Tegra Medical
Tegra Medical is a contract manufacturer of finished medical devices and complex components including surgical instruments, needles, and implants.
We’re headquartered in Franklin, Massachusetts and manufacture there, as well as Dartmouth, Massachusetts; Hernando, Mississippi; Heredia, Costa Rica; Altstätten, Hallau, and Heerbrugg, Switzerland; and Johor Bahru, Malaysia.
Formed in 2007, Tegra Medical is the combination of four trusted firms from the medical device manufacturing industry whose roots go back for decades. Tegra Medical is a member of SFS.
Our customers rely on our unique ability to integrate common and non-traditional technologies, e.g., laser cutting with CNC grinding and metal forming, to make complex products.
ABOUT Tecomet Inc.
Founded in 1963, Tecomet is the market-leading provider of manufacturing solutions for complex, high-precision products and services for the Medical Device and Aerospace & Defense markets. Tecomet operates seventeen (17) global manufacturing facilities in five countries around the world and employs over 2500 people.
With unparalleled experience in high-precision manufacturing, Tecomet provides a full spectrum of Manufacturing Solutions and Services in the following areas:
Tecomet customers feature a list of blue-chip Medical Device and Aerospace & Defense OEMs. The company partners with its customers to provide innovation solutions, design and development services, and full spectrum of high-precision manufacturing solutions.
More Flexible Electronic Manufacturing Means Better Medical Monitoring
To fit more reliably and comfortably when worn, wearable electronics must be flexible while retaining their ability to collect and communicate data. Conventional sensors and other electronic components, even when made very small, don’t often offer these attributes, which can limit their use as medical devices. A new additive manufacturing method from researchers at Harvard University’s Wyss Institute for Biologically Inspired Engineering makes it possible to create useful monitoring electronics that fit more comfortable and move naturally when worn directly on the skin.
Image Source: Wyss Institute
Hybrid 3D Printing
Through a process that the researchers refer to as hybrid 3D printing, electronically conductive inks can be incorporated into wearable devices that are not only soft and flexible, and therefore comfortable to wear, but can also be stretched and still perform reliably. The conductive ink is made from thermoplastic polyurethane (TPU) and contains electrodes, which can be layered with a soft, flexible substrate through an additive manufacturing process. As the ink solidifies, the result is a conductive, highly flexible, and fully functional circuit that can be used for a range of medical needs.
Image Source: Wyss Institute
Custom Fit For The Patient And Diagnosis
Since these soft sensors can be printed to just about any shape, and with the position of the conductive features determined during the manufacturing process, it’s possible to create medical sensory devices that fit the patient as well as the specific data to be collected. Researchers are able to collect information from a wearer’s movement or from the application of pressure and easily read the resulting data in a number of ways.
The hybrid 3d printing process has been noted as significant for the flexible and versatile devices it yields, as well as its relative low cost. While the resulting products are currently in the prototype stage, researchers have called this a first step in creating robust and affordable wearable electronics that are also comfortable and customized.
Have thoughts to share on this development? Let us know in the comments.
New Surgical Glue Could Render Stitches And Sutures Obsolete
When wounds are quickly and securely closed following injury, healing is faster, risks of infection are minimized, and more serious sustained injury can be prevented. A new type of surgical glue has been created to do that in a fast-acting and reliable manner. It may even change first aid and medical response procedures at car accidents, in combat zones, and at emergency sites.
Image Source: New Atlas
Fast Forming For Better Wound Healing
MeTro behaves like a silicone sealant, much like those used to create a water seal in bathrooms and other household applications, but it works even faster. Once administered to human tissue, MeTro rapidly forms to gel-like thickness and serves to seal a wound. This action occurs as highly elastic proteins and light sensitive molecules are set after being exposed to UV light. The gel takes just 60 seconds to thicken and solidify, which is vital to blocking out bacteria in urgent situations.
Modifiable For Recovery Times
While MeTro securely remains in contact with the tissue to which it’s applied, it retains some elasticity so it moves with the patient and prevents wounds from reopening. The treatment can also be modified with a degrading enzyme that determines how soon MeTro will begin to breakdown. Whether sealing is required for minutes or months, the gel can be catered to appropriate recovery times.
Image Source: New Atlas
For Use On Difficult To Treat Sites
Northeastern University and Australia’s University of Sydney Researchers responsible for creating MeTro have also shown how it can be used on treatment sites that are otherwise difficult to seal due to exposure to bodily fluids and natural expansion and contraction. The substance shows potential for use on vital areas that are challenging to stitch, suture, or bandage, such as internal organs like the lungs and heart.
As MeTro has been tested successfully on pigs, researchers are now focusing on trials in humans. Will their development render conventional wound healing and closing treatments obsolete? Comment and share your thoughts.