Taher Moiyed, CEO and Founder, Safey Medical Devices charts the journey to becoming South Asia’s and India’s first company ever to obtain US FDA clearance for its peak flow and spirometers
Pune based Taher Moiyed has been an asthma patient since the age of three. But it was only when he saw his daughter’s struggles to deal with the same condition, that he felt driven to do something about it.
He realised that since there were not too many home healthcare solutions for asthma patients like glucometers to measure sugar levels for diabetics and blood pressure monitors for hypertensives, asthmatics were dependent on healthcare staff to manage their condition.
So as a serial entrepreneur in the IT space, he decided to fill this gap and unmet patient need by designing equivalent homecare solutions for patients with respiratory conditions like peak flow, spirometers and smart inhalers.
He and his product development team had three goals – that they should be digital devices, should be pocket-sized and be affordable. He believes they have achieved all three goals.
Today, around four years since his moment of epiphany, his company Safey Medical Devices (Safey) is South Asia’s and India’s first company ever to obtain US FDA clearance for its peak flow and spirometers. These are new age smart/connected devices that manage dosages and monitor efficacy of the drugs for the specific patient over time which, according to him, make these devices unique.
The problems …
Explaining the problem faced by asthmatics and others patients who suffer from respiratory conditions, he says, “Home healthcare for asthma and COPD patients is rare and only available in the West. The solutions are expensive. There are no affordable solutions available for the South Asian part of the world. Therefore, we then came up with an idea to miniaturise the bigger devices (that are available at hospitals) while ensuring the accuracy is not affected. We knew that size matters when it comes to home healthcare.”
He assures that they have not compromised on device hardware, with the key components are manufactured by world-leading semiconductor companies based in the US and Germany.
Surprisingly, the devices currently sold in India market to manage these conditions were not manufactured here and were imported. Moreover, they are either non-connected i.e., manual and big in size. Most of such devices are unregulated and made in China.
Moiyed explains that all research about the illness, its diagnosis and control patterns was done in the UK. When it came to India, all they worked upon is a pricing structure to make it affordable for patients in India.
… and the solutions
But what makes Safey’s peak flow meters and spirometers score over existing manual solutions? How do patients benefits? What are its USPs? These devices are IoT enabled so what are the means to protect patient data, where is the data stored etc.?
The CEO and Founder, Safey Medical Devices points out that there is proven research, which shows that more than 60 per cent of asthma patients cheat on the meds. Thus the clinicians never have real visibility of what is going on.
With manual devices, the onus is on the patient again to provide information to their doctors by keeping a log of all the readings written down on a notepad. This is boring and not effective and more importantly, doctors cannot take any immediate action as they would never know when the readings are going down (as the patient would only meet the doctor once a month etc.)
This is where the Internet of Things (IoT) connect of Safey’s devices brings in real care for such patients. Real-time data transfer helps clinicians and loved ones provide better care for such patients, while the data is transferred through a highly encrypted channel and stored securely on the Amazon cloud for scalability, explains Moiyed.
Importance of global compliance for credibility
As a relatively new startup in the highly regulated pharma/med devices sector, Safey’s realised that they would need help when going through the process of challenges of getting their devices evaluated and approved by global regulators like the US FDA and CE. Hence they decided to consult with a global firm, UL.
Through their discussions with UL, Moiyed and team understood the significant efforts they would have to undertake to get their products to comply with global norms (EU and US markets) early on.
“We wanted a dependable partner to help secure the necessary clearances through relevant reports spanning patient safety aspects (electrical, mechanical, thermal and software), human-machine interaction concerning device usability aspects, biological compatibility and device communications from the perspective of radio connectivity aspects,” says Moiyed.
He points out that UL’s expertise in helping clients navigate the global compliance maze and technical competencies of regional staff set them up as a preferred partner to deliver global market access solutions for such ambitious projects with tremendous social impact. It took the company almost 10 months from the start to finish for the FDA clearance.
Reflecting on the process, Moiyed says, “UL involvement was an important one. It brought credibility to the FDA examiners too.”
As Safey Medical Devices and their devices are still relatively new in the India market and are also branching out overseas, he would not like publicly comment on how exactly he managed to keep the devices affordable, accessible and yet meet the standards of the US FDA, probably waiting for the doctor and patient community to make their assessment over time.
He is also unwilling to go on record for their go-to-market strategy and further products in the pipeline, probably as these will evolve and competition is ramping up in the homecare medical device space, especially post the pandemic.
But he is willing to say that their devices will be available at a third of the cost of imported devices currently being sold in the market.
Tips for med-tech start-ups
When pressed for tips for other med-tech start-ups, he has two important pieces of advice.
One, you will never ever get it right the first or even the second time.
And second, before you start any med-tech venture, make sure you have a solid plan, enough funding in place to back your plan and you are transparent with your shareholders about the time it would take to launch your product.
Safey Medical Devices seems to have its finger on the pulse of a fairly large patient population. The pandemic-inspired surge of homecare, connected remotely managed medical devices has come at the right time for them and here’s hoping that they can surf this wave well.
Good piece of information you shared. Loved it .