Front Line Medical Technologies: tech that saves lives
Dr. Asha Parekh is co-founder and CEO of Front Line Medical Technologies, a Canadian medical device company that has developed a product to stop internal bleeding. Parekh tells us how it's saving lives, and has advice for women who want to start a career in STEM.
Why did you found Front Line Medical Technologies?
Dr. Adam Power (CMO and co-founder) and I teamed up to develop a new device to make the REBOA (Resuscitative Endovascular Balloon Occlusion of the Aorta - a technique designed to stop internal haemorrhage) technique faster, reduce complications, and ultimately try to save more lives. We worked on this project prior to founding the company, which we incorporated in 2017.
At that point, we decided to give this a real go. We realised that we needed to have someone dedicated to it full-time, so I took the plunge from my engineering career pathway into entrepreneurship.
What are the key benefits of using the COBRA-OS compared to other devices?
The COBRA-OS offers a solution to stop internal bleeding in emergency situations when direct pressure cannot be applied. Two of the most important advantages of our device include its smaller profile and its speed. It is almost half the size of its competitors, allowing it to be deployed quicker and with fewer steps – in one minute, compared to an average of 8 minutes for current alternatives. This means less blood loss and greater chance of survival for the patient.
Trauma to the torso occurs where compression cannot be applied. This type of non-compressible haemorrhage from injury is the leading cause of potentially survivable deaths of American troops and second leading cause in the civilian setting.
Around 90% of these patients die before reaching definitive care, and control of bleeding is the only way to avoid the problems associated with haemorrhage in trauma. Our device provides the required support to allow for safe transport. It can also be used to direct and maintain blood flow to critical organs in other clinical applications.
Do staff require training to use it?
Our goal was to make the device as easy to use as possible so that the learning curve is minimal, but another factor that inevitably contributes to this is also the training or skill level of the end-user, such as a trauma or vascular surgeon vs. paramedic.
Where is it currently being deployed?
REBOA is mostly being used in hospital settings such as trauma centres, but it has also been used in some military settings. We believe that the usage will increase as technology evolves and more options are available to end-users.
What strategic goals does Front Line Medical Technologies have for the coming years?
Increasing availability of REBOA devices where it is wanted and needed most and increasing the usage across multiple applications. Our target markets are the military, ambulances, and hospitals.
The pre-hospital setting is a clear target; however, our product can also be used for several in-hospital applications such as postpartum haemorrhage, organ transplants, and cardiac arrest both in and out of hospital, which can increase usage and help try to save more lives across these other applications.
Looking back over your career, do you think there are more women in STEM careers now than when you first started out?
Yes, I do see that we have grown and have come a long way already. From my experience, we are making progress in what seems to be the right direction, but there is still a lot of work left to be done. More awareness is being raised around these issues, and more people are trying to make waves in the industry.
From my experience in engineering, from undergrad through grad school, females were certainly in the minority. By the time I was doing my Ph.D., women were still few, but there was a noticeable increase from what I saw in undergrad.
What would like to have know then, that you know now?
That it can sometimes be better to be more critical of who you work with and on what projects versus just doing anything and everything that comes your way. Working with reasonable people should not be understated!
What would you like to see change in STEM?
Having positive influences at a younger age and continuing to promote awareness around these areas can help. Additionally, STEM combined with startups are opening new doors for young students that are less traditional. They are incorporating things into the curriculum [at university] about the business side of things to show there are more options than what has been the norm in the past.
Deconstructing gender bias needs to start at the formative ages. We need to address our biases from a younger age and make it the "norm" for men and women to have similar interests. People get pigeon-holed into specific industries based on their gender, which doesn't need to be the case.
What would you say to young girls who might be considering a career in STEM?
Make sure it's something YOU want to do. Being passionate about your career choice is so important.
Continue to show up. If you face challenges as a female in STEM, it's that much more important for you to keep showing up and standing your ground for what you believe in and where you want to make an impact. It's the only way we can affect change. Enjoy the journey. Every bump in the road is still a part of what makes you who you are, and you will learn something from it.
Don't pigeon-hole yourself into traditional STEM careers either. You don't have to be a scientist in R&D or a math professor. Take some time to critically reflect on where and how you want to be a part of this industry and work towards that. You may want to be in a marketing role related to STEM, so you can take that angle and work towards it as you "pitch" yourself for potential positions.
Driving sustainability in medical device production
Environmental protection and stewardship are rapidly rising to the top of the corporate agenda and medical device businesses are no exception. The healthcare sectors of the United States, Australia, Canada, and England combined emit an estimated 748 million metric tons of greenhouse gases each year, an output greater than the carbon emissions of all but six nations worldwide. In order to curb this situation various European standards have been introduced.
The Waste Electrical and Electronic Equipment (WEEE); Restriction on Hazardous Substances (RoHS); Registration, Evaluation, and Authorisation of Chemicals (REACH) and the Energy Using Products (EuP) regulations have all significantly altered manufacturing processes, specific labelling, compliance with disposal restrictions, and creation of instructions for end-of-life management and recycling.
At the moment many medical devices are currently exempt from these regulations but several directives, including RoHS and WEEE, are in the process of being reviewed and could be applicable in future. This is especially relevant for devices that are ‘connected’ and have a digital monitoring component which then brings them under the regulatory purview of authorities that govern devices with electronic components.
Safety, Usability and Sustainability
While medical device manufacturers have been working to respond to increasing demand for environmental sustainability from the market, they also have to contend with a key element of their mission: to ensure safety and usability to healthcare workers and patients. Parenteral and other invasive devices are strictly regulated to help reduce the risk of Healthcare Acquired Infection which typically runs as high as 5% and 8% in most developed countries, according to the European Centre for Disease Prevention and Control. As a result, they typically contain disposable single-use plastic elements.
At the same time, many hospitals and purchasing organisations have started to recognise that sustainable purchasing practices play a pivotal role in reducing costs over time. Many GPOs have appointed and empowered Senior Directors of Environmentally Preferred Sourcing who are successfully implementing the sustainable purchasing business case. In addition global pharmaceutical companies are increasingly creating senior positions with sustainability objectives as key to the role.
Medical device disposal is a particularly burning issue; generally carried out through incineration in the EU, it typically releases nitrous oxide, as well as known carcinogens including polychlorinated biphenyls, furans and dioxins. Some of the strategies trialled by manufacturers to reduce waste matter destined to incineration include sterilisation and reprocessing.
Sterilisation, however, falls short on the environmental front, and may consume more energy and produce more emissions than incineration itself. In the United States for example, 50% of all sterile medical devices are sterilised with ethylene oxide but since this method releases harmful emissions, the US Food and Drug Administration is now encouraging the development of new methods or technologies. Many other established sterilisation methods use glutaraldehyde that is not only harmful to the environment but also tends to be regulated by strict usage and disposal rules such as COSSH guidelines.
Focus on Recycling
The outlook on recycling is changing significantly thanks to new research and technologies enabling, for example, monomer extraction. Recycled polymers can be broken down to their constituent monomers promoting an almost limitless recyclability of some polymers. In addition to this, Polyvinyl chloride (PVC), renewable polyethylene and polyethylene terephthalate (PET) can be recycled several times without losing critical properties.
Reducing the impact of packaging can also significantly reduce the materials that need to be dealt with through either waste or recycling. Packaging manufacturers are decreasing packaging volume by favouring sealed trays instead of pouches, laser-etching instructions directly on to the tray where regulation permits it, or reducing the number of components required overall. In addition to this, for recycling plans to be successful it important to have a full understanding of the practices surrounding device use and to establish, where possible, closed loop recycling systems that recover the waste materials from hospitals or patients and bring them back into the recycling process.
Sustainable Manufacturing: Technology and Research
Greater employment of fast degrading plastics or material from other sources is a key strategy to reduce harmful pollutants both at production and disposal stage. Bio-based materials can in fact offset the carbon emitted during processing as the monomer source grows, and a growing range of sources for bio based monomers -such as wood pulp or sugar cane- is available. However, when assessing the most suitable material for a part, the entire lifecycle of the product needs to be considered. For example: bio-degradable polymers can contaminate a recycling stream and emit methane when incinerated.
The use of environmentally friendly materials should also be supported by an increase in clean renewable energy sources. Lower energy consumption means fewer carbon emissions but also financial savings, making this an appealing measure for manufacturers. New technologies are proving a major gamechanger on this front, helping manufacturers marry their environmental stewardship with cost savings and efficiency. 3D printing, for example, can help develop optimum product moulds more quickly, refining production parameters to minimise raw materials volumes and maximising output productivity.
Similarly, ‘digital twin’ production software uses inline sensors to create a virtual, real-time mirror of the production environment to enable inline refinements. The objective is to achieve “zero defect”, waste-free manufacturing. In addition to this, LEAN manufacturing methodologies are already helping to optimise inventory management and reduce overproduction.
Sustainability by Design
It is increasingly clear that effective environmental sustainability in the medical device sector cannot exist without a full view of the product life cycle from concept development, material selection, design and engineering to manufacturing, packaging, transportation, sales, use, and end-of-life disposal. These evaluations are typically made for factors such as manufacturing efficiency, time to market, or safety and regulatory compliance, packaging and transportation costs, but should be extended to energy efficiency and environmental impact by means such as life cycle analysis.
In addition to this, with devices rapidly becoming more digitally connected, developers need to be aware that the costs of disposable electronics would simply not be viable, or indeed acceptable in the light of electronics disposal regulations. Design therefore should focus on creating a simple, repeatable interface between the two component sections so as not to impair the functionality or efficacy. As reducing waste and harmful emissions continues to exert businesses and governments globally, the medical devices industry cannot stand by. The environmental but also commercial implications of inaction are too serious and the array of solutions now available is exciting and diverse.