Medical Device: A medical device is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body (which would make it a drug). Medical device industry is already a USD 510B market worldwide and has the potential for further growth.
Discovery of what would be considered a medical device by modern standards dates as far back as c. 7000 BC in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Shushrut in ancient India (500 to 1000 BC) wrote a treatise on surgery called Shushrut Samhita. Study of archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. However, in the United States it wasn’t until 1938 that medical devices were regulated and thus became a distinct category.
Unlike drugs, many medical devices may not be evaluated using randomized clinical trials. Medical devices are, nonetheless, evaluated for efficacy and safety, based on data acquired from clinical investigations, field studies and laboratory experiments. However, the duration of studies are likely to shorter compared to drugs. Like pharmaceuticals, the medical device industry has its own regulatory systems. Medical devices have shorter product life cycles, since technical improvements are typically available within two years of a previous iteration, whereas improvements in medicines are more likely to take decades.
Medical devices are a heterogenous category consisting of simple thermometers, highly complex genomic testing devices and reagents, capital intensive radiography equipment and more. If your interests are in Diagnostic testing and devices used in diagnostics click here (link to Diagnostic Section)
The FDA categorizes medical devices into one of three classes – Class I, II, or III – based on their risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. Medical devices could also be segmented in multiple ways – by the body part they target – Orthopedic, Cardio, dental and auditory are major categories. Or by the medical application in the patient life-cycle, monitoring, prevention, treatment and life support devices. Ageing population and increasing life expectancy provides a boost to the need for life sustaining (pace makers, stents) as well as well as life enhancing (orthopedic implants, ear implants, prosthetics) devices.
Advances in materials and electronics have significantly contributed to innovations in medical devices. There has also been a resurgence in devices used for treatment facilitated by, as you might guess, silicon technology – be it embedded and connected computers smaller than a thumbnail or pervasive power of the cloud computing. A lot of the progress made in the devices is relatively new but groundbreaking- and it has been facilitated by advancements in fundamental sciences as much as by engineering.
We see few key trends shaping medical device industry in the next decade.
Demand for safer procedures: Surgical procedures that depended a lot on physician skills are evolving due to innovation in medical devices. Cataract procedures used to be carried out with a large incision around the cornea. Phacoemulsification has made the procedure simpler and safer which is carried out using a tiny incision around the cornea. Similarly, vision correction surgeries (LASIK), joint replacement, hair restoration, laparoscopic surgeries among others have become safer due to medical device innovation. Safer procedures also help penetration of medical procedures to a much wider patient population.
Use of machine learning and AI: Use of ML and AI in radiography and pathology images are in the early stages of application. A wider application is only a matter of time.
Healthcare at home: Patient preference to manage their long term conditions at home is driving device innovations to make remote healthcare management feasible.
Higher burden of proof for payor approval: As healthcare budgets get squeezed, medical devices will need to invest in demonstrating efficacy. Rather than primarily selling products on a per-unit basis, forward-thinking companies are developing more comprehensive solutions (including services) that can create value throughout a patient’s journey. These solutions often have a higher price point but ultimately save money for purchasers such as clinicians, hospitals and patients.
International Growth: Unlike drugs, where developing countries have developed a generics industry, and significant humanitarian initiatives have ensured a developing country demand base, medical devices are still a developed country phenomenon, beyond diagnostics. Tremendous potential exists for cost reduction as well sales growth by globalizing the industry, given a lot of ageing patients will be from outside the rich world.
EPPIC membership has representation from leading medical device companies, companies that in their own right are advancing the state of medical devices through innovation in material science, electronics and software. We also have in our membership a thriving entrepreneurial spirit working to find new opportunities at the confluence of traditional devices and digital technologies. Wearable monitoring devise are one such example.
How can EPPIC help?
EPPIC could help you navigate the complex evolving landscape of medical device sector by providing access to quality professionals across the whole spectrum.
- Provide an Ecosystem to nurture your medical device start-up: If you are a medical device entrepreneur the biggest challenge is often to find all the stakeholders of the health ecosystem in a single place. Given the broad platform that it is, EPPIC increases the probability of your being able to put together your advisory team or find catalysts/ mentors from the various parts of the health ecosystem.
- Professional Transition: EPPIC can be a platform to understand opportunities in the space and how best to plan your transition.
- Exposure to the possibilities of technology: As a Silicon Valley based healthcare networking group, EPPIC is in a vantage position to observe the latest innovations in medical device and bring it to its members. Our events showcase some of the cutting-edge start-ups and speakers on medical devices.