S2.E1: Government Policies and Frameworks for Diagnostics at Last Mile

26th February 2020

Author: Mr Pavan Sannuti and Dr Vandana Sarda

Blog CATEGORY: Diagnostics 4.0 Webinars

ABOUT Mr MOHAMMAD AMEEL

Mr Mohammad Ameel is currently working as a Senior Consultant & In-charge, Healthcare Technology Division and Head – WHO collaborating center for priority medical devices & health technology policy at the National Health Systems Resource Centre. He spearheads the work of establishing technical specifications of medical devices for procurement under the National Health Mission (NHM). He also leads the work of identification and uptake of innovations that are of value in public health programs. He was recently invited by Harvard University under Harvard Project for Asian and International relations (HPAIR) to talk on uptake of health technology innovations under public health programs. The division of Healthcare technology also leads the work on Biomedical Equipment Maintenance Program, National Free Diagnostics Program (which includes free pathology service and radiology services), National Dialysis Program and other technology-intensive healthcare Programs under National Health Mission (NHM). He has developed expertise in both product and service procurement through Public-Private Partnerships (PPP) under the Ministry of Health & Family Welfare.

About Mohammad Ameel

He earlier served as the Head, Biomedical Engineer at Era’s Lucknow Medical College & Hospital while also consulting other hospitals around the region on engineering services, especially for NABH. He is a technical columnist for various National Magazines on the topics of medical devices & Healthcare Technologies.

As a fellow of India’s first international fellowship on Health Technology Assessment (HTA) he has authored several health technology assessment reports including the one presented at Global Medical Device forum at WHO Headquarters, Geneva. He also got the privilege to represent India in the 3rd WHO Global Forum on Medical Device, Geneva and proposed the next forum in India in December 2018. He was recently conferred with prestigious award ‘100 most impactful healthcare leaders’ (Global listing, 2018). He was also recognized for his outstanding contribution to Medical Devices & Healthcare Technology field at the 8th MT India Healthcare Awards, 2018. He got the opportunity to accompany the Hon’ble President of India on the business delegation to Prague, Czech Republic in September 2018.

He has co-authored:
• National Policy on National Biomedical Equipment Maintenance Program
• Guidelines to setup medical device Testing Laboratories for EMI, EMC and Biomaterials
• National Free Diagnostics Service Policy
• Indian Certification for Medical Devices (ICMED) Scheme
• WHO Technical specifications for oxygen concentrators
• WHO Technical Specifications for Neonatal Resuscitator
• National Dialysis Service Initiative (under Public-Private Partnerships)

He is a member of:
• Member Medical Device Technical Advisory Board, Government of India
• Member, Working Group – Technical Specifications for Blood Pressure measuring devices, WHO Headquarters
• Member, National Technical Advisory Board (NTAB) on Cold Chain Logistics
• Member, Electromedical Equipment Sectional Committee, Bureau of Indian Standards
• Member, Oxygen Therapy Review Group, UNICEF/WHO Headquarters
• Collaborator, International Federation of Medical and Biological Engineering (IFMBE)
• Member of Technical Committee of National Cold Chain equipments Specifications
• Member in technical committee in QCI – AIMED Voluntary Initiative on Medical Devices
• Assessor (Technical Expert), National Accreditation Board for Certifying Bodies (NABCB)
• Trainer, Materiovigilance Program of India

KEY WEBINAR HIGHLIGHTS

14:05 – 15:06
Hub and spoke model for diagnostics at last mile in Health & Wellness Centers
 
What we have envisaged is to have a hub and spoke model created wherein the sample collection will happen at the PHCs and the tests, routine tests would be conducted in the large CHCs or some of the sub district hospitals. This large CHCs and SHs would be catering to about 10-15 number of Primary Health centers.What we actually want to ensure is that rationalization of HR happens because we cannot invest on trained technician in each and every Primary Health centers.So what we have ensured is a good mechanism of Hub and Spoke model up to the CHCs and the Health and Wellness Centers.
15:58 – 17:58
Benefits of Hub and spoke model in Health & Wellness Centers
 
If you are providing diagnostics in a hub and spoke model, what you are able to provide is provisioning of expanded menu of diagnostics….you could reduce cost by capital procurement, in requirement of HR and its training, you could reduce cost in supply chain management…..and you would obviously improve monitoring. Thirdly, you will improve access. How you can improve access is because you will have better equipment repair…. You can take care of absenteeism….you have mechanisms for quality assurance which is more possible.
18:24 – 19:18
Call out to innovators for PoC diagnostics at PHCs
 
Some of the innovators who are joining us will have to look at this model and suggest some good rapid diagnostics, point of care diagnostics at the level of the health facilities which would ensure that there is lesser number of sample transportation because in the PHC we have only 20 diagnostic tests which are approved or validated…other 44 tests we have to do the sample transportation which is obviously not the best way…we have to have some good entrepreneurs investing in sample transportation or investment in some low cost lab information systems….those are some of the innovations we would be looking at.
20:15 – 20:31
Digital intervention of the PoC diagnostics required
 
We also have to look at digital interventions of the point of care diagnostic to a computer system through a blue tooth through a wi-fi or any other mechanism so that clerical errors are totally removed, manual intervention in diagnostics would be the worst thing we would want.
26:20 – 26:48
Only diagnosis is not sufficient – STEMI program as an example of successful outcome post-diagnosis
Supposedly a tele-ECG device tells a doctor or even a doctor is able to tell that this is a STEMI case. Even if the doctor thrombolyses it, it does not solve the purpose. The purpose actually is to ensure that he arrives in a hospital where he has a cath lab. So this STEMI program actually closes the loop….Sometimes a diagnostic test alone is not sufficient in some cases.
28:17 – 28:44
National Health Innovation Portal as starting point for entry into public health system
How in case you have some good innovations you could upload on our National Health Innovation Portal which is an online submission mechanism at www.nhip.org. There is first level of screening of submission that happens and then there is a committee which looks at appropriate devices for approval and then the Ministry approves it. So, in case the Ministry recommends it, this device goes for Health Technology Assessment at the Dept of Health Research and if it is recommended there then this technology is recommended for uptake in the public health systems.
34:12 – 34:44
How to make chances of your selection very high through National Health Innovation Portal
In order to make the chances of your selection very high it is very very important that you have generated some kind of evidences, you should have some published evidences, some published inputs in high index journals. This ensures that when Health Technology assessment happens, so systematic reviews give good results. That increases your chances and reduces our time in assessment.
38:35 – 39:06
Advocate for sensible regulations for start-ups and innovators to have an equal say as any other MNC
 
The patient safety comes first if you look from a user’s perspective. So that’s why they go for European CE and US FDA. So, actually, the end goal is and your end demand should be when you have the patient in the center you will also think of patient safety. We should advocate more for having regulations, more sensible regulations which will allows start-ups and innovators have an equal say as any other MNC has in the system.
42:07 – 43:44
Communication gap regarding type of technology needs to be looked into, for better uptake and adoption
 
The problem is communication. And the reason I say so is requirements for a public health system is very very unique and very different from what a tertiary care institute in a private sector looks at or even a secondary care institute otherwise looks at…the communication gap that we have is only with start-ups but also with lot of medtech giants…..in the current diagnostic space what happens is the most efficient diagnostic equipment….are at the district level with the best of the best technicians and the most complex diagnostic equipment which are semi-automated or most of them manual use, are with the most untrained technician or the staff in the field which is very very reverse….actually we should have easy to use devices for these people in the peripheral health facilities which makes their life easy.

ABOUT DIAGNOSTICS 4.0

Many of you participated in the MedTechConnect All Partner Workshop in July at the Cyient office in Hyderabad. We had a truly diverse crowd, with approximately 40 partners from organizations across the value chain present in the room. to ideate, collaborate and create solutions to very specific problem statements. We worked through structured and interactive sessions to identify specific areas in which we could drive impact.

We also left the room agreeing that it was important for the ecosystem to continuously meet, and this Webinar series is an attempt to do just that.

Diagnostics 4.0 webinar series is divided into Seasons, each season will have episodes. The first season is Diagnostics at the Last Mile. It was successfully concluded with a report on insights from all three episodes. Season 2 is on Perspectives on policies and regulatory of Diagnostics. Diagnostics 4.0 is the latest offering and endeavour from MedTechConnect in an effort to strengthen the medical technologies ecosystem in India.

During our first episode of Season 2, we had the honour of talking with Mr. Mohammad Ameel. He spoke with Dr. Vandana and Mr. Pavan

For the new partners, MedTechConnect is a collaborative healthcare ecosystem platform led by Cyient and Xynteo/India2022 coalition.  Our vision is to accelerate the journey of medical technology from the lab to market and help improve affordability, availability, and accessibility of these solutions to the last mile.

Founded in 1991, Cyient provides engineering and technology solutions to global industry leaders. We deliver innovative solutions that add value to businesses through the deployment of robust processes and state-of-the-art technology. We work across multiple industries, from Aerospace to communications, transportation, energy. We have also been active in the Medical technology space for the past 10 years and is one of our fastest-growing industries.CYIENT is a partner in the Xynteo/India2022 coalition and leads the Healthcare impact track.

Xynteo is a platform for galvanising leaders and catalysing ideas – and fusing them into new projects, for new growth. India2022 is a business-led coalition committed to leveraging the power of collaboration to unlock future-fit growth opportunities in India, aligned with the government of India’s development goals. In Healthcare, we are looking to make affordable diagnostics accessible to as many people as possible.

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