This article details strategies and challenges for creating a medical device in 2020.
In order to understand the opportunities and challenges for medical devices in 2020, we first need to understand what got us here. Most of these facts will be known to you, but lets review them to ensure general consensus. In February and March of 2020, the initial COVID-19 crisis in Wuhan, China led to global panic and uncertainty about whether hospitals would be overwhelmed. There was an almost universal reflex to lockdown countries immediately, to limit travel, and to inhibit movement to control the spread.
Then, the clampdown on economic activities precipitated an unprecedented economical crisis which will undoubtedly have long-lasting effects. Following this, governments transitioned from a ‘flattening the curve’ approach to a ‘minimize’ approach, in order to stimulate the economy a bit more.
In many areas, the pandemic and its effects were not as bad as they were expected to be. For this reason, some may call the COVID-19 pandemic the ‘Great Panic of 2020’.
Below are just a few of the immense impacts that the coronavirus pandemic has brought upon:
While there might be a vaccine in 2020, it might not be mass produced until 2021 or even later. If you want to learn more about the challenges facing vaccine developers, check out this article.
Also, many countries are starting to ensure their own local population access to vaccines before others. This will lead to competition for vaccines and less international collaboration. As you can see, countries are starting to look within themselves instead of reaching out to others for help in this pandemic.
Because the healthcare industry has been focused on the COVID-19 pandemic, there have been many immediate negative impacts on the medical device industry. Firstly, there have been far fewer elective procedures. This means there have been less consumption of medical devices, excluding ICU and sterility related products. That means, in the future, some expired devices might have to be destroyed or re-sterilized. This has also led to decreased sales for many device manufacturers.
In terms of the early stage approval process, a lack of in-person meeting opportunities with agencies (specifically the FDA) has led to significant delays. This will most likely have a major impact on clinical studies in the future.
Despite all of the negatives that have come from the COVID-19 pandemic, it has led to several positive outcomes. For example if your product or service can be marketed to coronavirus patients, it is most likely doing well.
That being said, there have been multiple cases of ineffective or even dangerous products flooding the market. People are trying to take advantage of the general population's fear regarding the virus. It is unclear whether or not these ineffective products (that have already been placed on the market) will be removed or approved by the FDA later on.
One of the most notable European development is that the European Union (EU) has decided to postpone the Medical Device Regulation (MDR). This means that companies that have innovations related to the coronavirus will be able to place their product on the market without getting an MDR. This is only applicable in their own market (AKA their own country, or whichever country grants permission). An important note: requirements under the MDR for PMS, Vigilance, Economic Operators, etc will become valid starting May 26, 2021. So, companies will need to eventually receive further approval.
Another important day is May 26th 2025. Devices placed on the market under the Medical Device Directive (MDD) or Active Implantable Medical Devices Directive (AIMD) “may be continued to be made available” until this date.
The question in regards to the EU is whether or not these measures will be enough. Many of the organizations and agencies within the EU medical field are still transforming because of the coronavirus pandemic. Many deadlines have been pushed back by a year to 2021. But, once these organizations and agencies have organized, they will most likely start to regulate more heavily.
If your company is thinking of expanding to Europe you should research the EU’s new deadlines and new protocols because of the COVID-19 pandemic. This will allow you to see whether or not expansion is realistic for your budget and resources.
For new information regarding Medical Device Coordination Group (MDCG) guidance, check out this website. It is updated by the MDCG when there are new expectations and guidelines medical devices need to follow.
The COVID-19 pandemic has brought about major changes in US regulations. Because of the urgency of the pandemic, the Food and Drug Administration (FDA) has begun to issue Emergency Use Authorizations. These were prompted by the glaring unpreparedness of US healthcare systems for a pandemic. Check out this website for more information.
The FDA and their priorities were heavily disrupted by the pandemic. One of the most glaring examples is the effect on their meeting schedules. Many in person meetings were canceled or postponed. Just now (mid-October 2020) the FDA is starting to resume these meetings.
From around February to May 2020 there were little to no Institutional Review Board (IRB) approvals, no pre-sub meetings, and very few other reviews were completed. If you want to learn more about working with an IRB (during non-pandemic times) check out this article.
Essentially, everything regarding clinical studies in the US (including patient recruitment) was frozen. This has been an obstacle for many clinical researchers, but the best thing to do is to wait it out. It can and will be frustrating but it is definitely better than throwing away the hard work it took to get there.
Challenges to clinical studies and their severity level depend on the type of study being done. If it is for pressing medical issues it is more likely to be quickly approved than an non-emergency study. Also, many issues arise from data collection. If monitoring and data collection can be done remotely it may be more likely to be approved.
Many opportunities in clinical studies during this time will come from remote work. For example, If there is a possibility of collecting data from a machine instead of a personal doctor’s visit. Sadly, there are many on-site visits that are hard to avoid, and you need a physician to evaluate the study participant. In these cases, waiting it out or trying to modify to be as safe as possible are the main options. These visits can be reduced to initiation and closing visits.
In most cases, studies will be ‘salvageable’ even if they are extremely impacted by COVID-19 precautions. It is best to talk to the FDA to receive some guidance on how to save a study.
Q: As COVID-19 will be with us for a while, how will remote monitoring most likely evolve?
A: It will depend on the study and whether or not remote monitoring is possible. It looks like remote monitoring will be used for clinical trials that do not require a physician to physically check the patient.
Q: Will Europe be ready by May 2021 for clinical studies? Or will some aspects function and others not?
A: There is a high chance that Europe will be ready by mid 2021. It is hard to exactly quantify ‘readiness’ but it seems that northern Europe is on the right track. One must also take into consideration whether or not the EU will make a collective decision to reopen or if countries will decide individually.
Q: What is the FDA’s attitude toward rescuing an ongoing study that might be voided?
A: It will depend on the situation. Many small businesses or independent researchers can directly contact the FDA if they have individual questions. Read more about their contact information here. Or, small businesses can use the posted FDA guidelines to help create their course of action.
Q: How have clinical trials to beat COVID-19 been going?
A: Vaccines and studies regarding a cure need to be slow enough to be accurate. That being said, these studies are under an immense amount of pressure to deliver results quickly. While they may be ‘going well’ it will be a while before we have any physical results to show for their work.
Dr. Jaap Laufer has over 30 years of medical device regulatory experience and specializes in implant and high-risk device submissions, FDA QSR compliance, and clinical study approvals and compliance. As Medical Director, Jaap is an expert reviewer of clinical data and evidence for novel and high-risk devices. In his additional capacity as senior clinical consultant, he also peer reviews EU Technical File submissions, and assists with Notified Body selection and classification.
If you want to learn more about finding success for a biotech startup, check out this ULP article.