Biological sciences medical device breakthroughs for this decade have a solid base to build upon. 3D tissue printing, advancements in cell therapy and regenerative medicine and gene editing breakthroughs were developed and adopted in the last decade.   Developing these technologies into commercial products and practical medical devices will be the work of the 2020 decade.

Here are my top 5 medical device breakthroughs that will be enabled by a partnership between biological sciences and engineering.

Here are my top 5 medical device breakthroughs that will be enabled by a partnership between biological sciences and engineering.

1. Gene Editing: CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) and genome editing allows genetic code to be modified so that diseases and pathogens can be eliminated. With further development, it may completely revolutionize medicine as we know it.   Genetic mutations are the cause of more than 10,000 diseases in humans.

Techniques and medical devices to correct faulty genetic information would represent a significant revolution in medicine.   Development of a gene-editing tool that allows scientists to modify DNA and genes offers a way to tackle conditions that were previously considered incurable. In early clinical trials, a patient has been successfully treated for sickle cell disease using the technology. Clinical trials using CRISPR to treat cancers such as non-Hodgkin’s lymphoma are currently recruiting.

Gene Editing technology has been called the discovery of the century.

Perhaps even more remarkable, gene editing is being utilized on the infections diseases front to eradicate multi-drug resistant superbugs, Malaria and even HIV.  Gene editing technologies are not without risk and serious ethical considerations.  The developing nature of this promising technology reinforces the importance of developing gene editing related medical devices in the regulated environment of ISO 13485.

2. 3-D printing: Medical devices can now be matched to the exact specifications of a patient by utilizing 3D printing technology. Designed to be more compatible with an individual’s natural anatomy, devices modeled from patient-specific dimensions have shown greater acceptance by the body, increased comfort and improved performance outcomes.

Osseus Fusion Systems recently received FDA clearance for a medical device that uses 3-D printed spinal implants made from a titanium material that allows spine tissue to grow through the implant and fixate better.

The more remarkable application of 3D printers in medical device development is BioPrinting.  This is where the printers are designed to print with tissue instead of traditional materials like titanium and polymers. Bioink—a complex mixture of natural polymers, synthetic polymers, and human cells is used for bioprinting tissues.

The current state of art 3D tissue printing technology, known as the Integrated Tissue and Organ Printing (ITOP) System, is a 3D printer capable of creating muscle, cartilage, and bone.  Currently, no lab has been able to 3D print blood vessels and capillaries capable of sustaining an organ. However, the race to 3D print a fully functioning organ is currently on. Along the way, this will lead to lesser breakthroughs in the near future that will improve countless lives in the interim (e.g., skin printing on demand, and organoids on a chip).

In this coming decade, 3D printed human organ replacement and joint repair will become a standard of care. 

While there are obvious direct connections between 3D manufacturing and 3D bioprinting, printing organs that function within the human body requires knowledge and technology extending far beyond the typical 3D printing process. Because of this, 3D printing tissues and organs represents an ideal case for medical device breakthroughs that will only be enabled by a partnership between biological sciences and engineering.

3. Medicine and Advanced Cell therapies: As the name implies, Regenerative Medicine involves the re-growth or re-generation of damaged body parts or diseased cells requiring therapy only available at the cellular level. As with printing tissues using 3-D printers, this field is still in its infancy. Early successes in clinical trials evaluating relatively simple tissues like cartilage regeneration are inspiring the promise of future whole organ regeneration. This makes it “a game-changing area of medicine with the potential to fully heal damaged tissues and organs”.  Commercial advances in this field will be enabled by the incorporation of good manufacturing practices (GMP) and medical device regulatory considerations into the tissue processing and tissue growth technologies currently being driven at the lab bench scale.  This will be the challenge of the decade.  For additional information, read How Regenerative Medicine will transform therapeutic medical devices and Two considerations for regenerative medicine medical device design.
4. Ingestible Diagnostics, Nanobots and Smart Drugs: As it was in the commercial electronics space, miniaturization is the critical technology multiplier in the field of Ingestible tech, diagnostics and smart drugs.  A classic example of this is Covidien’s pill cam. It offers a replacement to complicated colonoscopies and invasive diagnostics  that has inspired a revolution of autonomous ingestible diagnostic and therapeutic technologies in the field of gastroenterology.

In 2017, a smart pill was introduced that alerts patients via an iPad that it’s time to take their medicine.  If a patch the patient wears on the abdomen fails to pick up a signal that the pill has been taken, the patient receives an alert.  Another new smart capsule currently in development can be used to diagnose and treat disease, as it is trackable on its journey throughout the body.  This microdevice could monitor brain, blood and gastrointestinal tract activity, measuring factors like temperature and pH levels and delivering that information to doctors.

The next level is Nanotechnology (or at the scale of one-billionth of a meter) a field wherein human lives are improved at the level of atoms and molecules.  Nanorobots are machines that can manipulate environments and biological matter at an atomic level.  The therapeutic or diagnostic applications for ingestible untethered robots that can move within the body autonomously or through remote-controlled systems is practically limitless.   There would be capacity to detect disease, cancer, or infectious agents and precisely target treatment by cutting off blood supply to malignant tumors or locally administering radiation and/or chemotherapy.

Irrespective of the application, development of macro ingestible or nano-robot theranostic technologies is based on combining a knowledge of microscale manufacturing, micro electronics, microfluidics, and the interactions with biological molecules or biological fluids and tissues at a molecular level.

5. Immunotherapy: CAR-T (Chimeric Antigen Receptor-T Cell) technology literally represents a cure for some cancers.    Immunotherapies (a technique that uses the body’s own immune system to fight cancer) have existed for decades.  Antibody targeted drug therapies (i.e. Herceptin)  are able to specifically target cancer by being able to detect changes in cancer cells on the molecular level. Significant strides are making practical cancer treatment a near-term reality.  CAR-T advances take this approach to the next level by essentially modifying and empowering the patient’s own immune system to identify cancer cells and actively fight them.   Continued advancements in engineered T-cell treatments and on-going discovery of new immunotherapeutic targets and biomarkers suggest that medical devices rooted in immunotherapy based approaches will be at the forefront of future cancer treatment options. There is hope that effective therapies will soon exist for all tumor profiles.

Currently the physical technologies involved in generating the immunotherapies is very large (physically taking up an entire hospital suite) and prohibitively expensive with treatments ranging in the hundreds of thousands of dollars.  Near future development in this therapeutic area will almost certainly focus on miniaturization and near-patient processing technologies to democratize and improve accessibility. Engineering teams working closely with biologists versed in the handling and T-cell modification techniques will lead the development charge in the 2020’s.

As highlighted by these top 5 medical device breakthroughs, the next decade holds the promise of significant advancement and change.  Traditional medical device development paths will integrate biological technology development and device engineering. A medical device may be the biology itself where organs are programmed to re-grow, genetic mutations are edited out, or entire organ systems are simply 3-D printed with our own cells and replaced.

Unifying the science and engineering base underlying these seemingly disparate product development streams will aid development of medical device breakthroughs through the next decade and beyond.