MEDICAL DEVICE ESTABLISHMENT LICENCING

In August 2016, the Registrar of the Medicines Control Council, Dr J C Gouws, issued guidelines for A Licence to Manufacture, Import, Export or Distribute Medical Devices.

This in effect, is the first practical step towards Medical Device registration in South Africa, after the publication of amendments to the Medicines Act, brining into being the South Africa Health Products Regulatory Authority (SAHPRA), and extension of the remit of the MCC to regulate CAMS, Medical Devices and IVD’s

All companies involved in import, manufacture, distribution or export of Class B, Class C and Class D medical devices and IVD’s are required to apply for Licencing before 1 February 2017.

We provide the following project and advisory services to assist Medical Device Companies to comply with Medical Device Establish Licence Requirements and submitting Licence Applications:

  • Classification of Medical Devices according to the MCC guideline;
  • Guidance on document requirements from international suppliers;
  • Compilation of Site Master File and CTD;
  • Implementation of a Basic Quality Management System;
  • Skills transfer and training;
  • Completion of Licence Application.MBAC

For more information on how we can help your company, contact Mark Banfield on 0834072222 or via email.

Removing Healthcare Barriers with Telemedicine

Removing Healthcare Barriers with Telemedicine

Director at Mark Banfield & Associates Consulting (Pty) Ltd, Mark Banfield, discusses how telemedicine is transforming healthcare access in Africa.

Telemedicine - EHN
Telemedicine has been connecting patients to healthcare for almost 30 years, but continuous barriers, such as resistance from clinicians, prohibitive costs and more recently, an inability to meet bandwidth requirements have hindered the uptake of telemedicine. Director at Mark Banfield & Associates Consulting (Pty) Ltd, Mark Banfield, discusses how these challenges are being addressed with eHealth innovation and how telemedicine is effectively transforming healthcare access in Africa.

The popularity and ease of access to mobile technology has resulted in more and more clinicians and nurses incorporating them into their workflows. While WhatsApp, Skype and similar IM applications are useful communication tools, they lack the security and clinical functionality to share confidential patient files, images and narrative – and that is where robust mobile telemedicine technology comes in.

Telemedicine for low-resource environments

Last year I founded AfriHealth, an organisation which supplies medical devices and health technology to the South African market. One of the eHealth suppliers we represent is Canadian-based Tech4Life Enterprises, which are the developers of a mobile telehealth solution called MDConsults that was specifically designed for low-resource environments.

MDConsults was designed to address a lot of the challenges we face Africa; the system is cost-effective, easy to use and can run on a slow internet connection like 2G. MDConsults has a range of features such as live video-conferencing and the ability to incorporate special telemedicine devices to capture patient vitals, etc. and support diagnosis, as well as reporting of radiology and pathology images.

Use in real-world settings

To date we have been involved in 16 implementations of MDConsults in low-resource settings, from Pakistan to numerous countries across Africa.

With funding from the Zimbabwean government, we’re currently running a pilot with a hospital group in Zimbabwe where a single doctor and a few of his colleagues are responsible for 40 remote clinics. Previously, the staff had to use Skype and satellite telephones to communicate. But now, in the five clinics piloting MDConsults, the proper securities are in place which allow them to conduct teleconsultations with the added advantage of incorporating electronic medical records (EMRs), notes from clinicians at the clinics, as well as various images. As a result, clinicians are now able to engage with their patients in a more holistic manner.

From the feedback we’ve received it’s apparent that the system has truly changed their work practices for the better. Patients and doctors no longer have to travel long distances, and patients can now more easily access professional care from a specialist when they need it, as opposed to having to rely on a nurse or a GP at a clinic.

MDConsults has also been deployed in various projects in Kenya, from an on-going psychiatric programme to monitor and evaluate patients remotely, to providing paediatric support to outreach clinics to improve the triage process.

Preparing South Africa for telemedicine

South Africa faces a unique set of challenges when it comes to implementing telemedicine but I think it’s important to see what is possible within the confines of regulatory frameworks rather than take no action. Firstly, by law you have to obtain informed written consent from patients before telehealth can be used. This is problematic in most instances.

Another issue is data security, specifically in relation to the requirements stipulated by the POPI Act and National Health Act with regards to how personal data is stored and transmitted. Currently, data generated by MDConsults is hosted outside of SA, so we have to look at how we can partner with local service providers like Vodacomto secure local hosting to overcome that obstacle.

The third issue, which is less serious, is the requirement for clinicians to have a relationship with their patients to make a diagnosis. With MDConsults, we avoid this issue because a local healthcare provider, who is known to both the clinician and the patient, would be providing the service of connecting the two parties.

Ensuring quality and patient safety

Telemedicine works really well in certain clinical disciplines and less so in others. Psychiatry and dermatology are the two fields that benefit the most directly from telemedicine services at this stage. Psychiatric patients don’t need point-of-care devices, but they do need on-going monitoring and interpretation of lab results. In that case, blood can be taken at a clinic and the results can be uploaded onto the system and attached to that particular patient profile. The doctor can then consult with the patient while looking at their lab results at the same time.

Dermatology on the other hand is a field which is very difficult to make a diagnosis in. Typically, a patient will present with some sort of skin condition which is treated with a very broad spectrum cream, and it’s only when the problem persists that they would then be referred to a specialist who needs to see them face-to-face. But if you’re using a dermoscope or a microscope that can capture an enormous magnification of the affected area, you can make a diagnosis remotely.

Beyond traditional telemedicine

Point-of-care devices are making a marked difference in offering clinical decision support to rural doctors – much like an electronic stethoscope that Tech4Life has developed. During a teleconsultation the onsite healthcare worker positions the device onto the patient’s diaphragm under the guidance of a remote doctor. The doctor is then able to hear those sounds directly which can help him make a diagnosis.

Other devices we supply include a maternal risk band, which provides non-invasive haemoglobin readings as well as blood sugar, blood pressure and pulse. We also have various optical devices, such as a microscope which would be used in dermatology, and a range of otoscopes.

All of these instruments are USB plug-and-play devices which transmit captured images or sounds via MDConsults’ platform, and can be recorded during the teleconsultation. There are also devices that are connected via embedded SIM cards that send results from the point-of-care device to the treating clinician.

Extending to education

Telemedicine systems are also a great tool to continue medical training. Community doctors working in rural settings often have no backup, resources or experience available to them when carrying out their jobs. Telemedicine can change that, offering doctors support while giving them the opportunity to continue their education at the touch of a button.

This benefit of telemedicine presents numerous opportunities to address the lack of skilled healthcare professionals and improve the skills of those we do have. Imagine linking all public health facilities, from academic hospitals to rural clinics, with telemedicine systems to enable consultations regardless of location? I think as technology progresses and connectivity expands, this sort of connected healthcare ecosystem could become a reality.

For more information contact news@eHealthNews.co.za, like us on Facebook or tweet us @eHealthNewsZA.

eHealth News ZA

Budget 2016: What you need to know

Moneyweb

Most significant announcements related to tax changes and government expenditure cuts.

Moneyweb

State can’t afford doctors

Despite doctors being outnumbered two-to-one by Department of Health administrative staff, medical posts are being frozen.

There are more payroll clerks, managers and human resources officers in the department than doctors. The number of administrative employees increased by 12%, according to the SA Medical Journal, from 34 284 in 2012 to 37 336 in September last year.

But the number of doctors employed increased by only 3.5% during the same period, from 18701 to 19352, according to the journal.

The situation is likely to get worse, with medical posts being frozen in Mpumalanga, Free State, North West, Eastern Cape and KwaZulu-Natal, according to the SA Medical Association.

Doctors at Cape Town’s Groote Schuur Hospital have said medical departments are considering cutting costs, leading to fears that doctors will not be hired to replace those resigning.

Compounding the problem is that the Health Professions’ Training and Development Grant, and the National Tertiary Services Grant – made to universities for the training of registrars, the future specialists – has barely increased, by just over 4%, this year.

Mark Sonderup, vice-chairman of the SA Medical Association, fears that more doctors’ posts will be frozen: “The most expedient mechanism to achieve budget cuts is to freeze posts.”

The KwaZulu-Natal health department trained only 39 specialists in 2014 compared to 165 in the previous year.

A source in KwaZulu-Natal said: “Registrar posts have been frozen for 18 months. I don’t understand why doctors don’t protest.”

The freeze means there are 150 fewer specialists produced each year on average. The average age of specialists is 55, which means a crisis will develop when those now in practice retire.

DA KwaZulu-Natal health spokesman Imraan Keeka said it was not known if any registrars would be trained this year.

He said 9783 health department posts were vacant for 2015-2016.

These include 2827 nursing posts, 17 CEO posts and positions for 14 dentists, 25 dieticians, 259 general practitioners, 179 specialists, 86 radiographers and 88 pharmacy assistants.

Only nine human resources manager posts are vacant.

KwaZulu-Natal health spokes- man Sam Mkhwanazi said: “The policy on the freezing and unfreezing of posts aims to control the process of recruitment and filling of vacant posts to ensure critical and essential ones are filled.”

But a Durban doctor said it took months to unfreeze a post. Medical Association chairman Mzukisi Grootboom said a lack of hospital and clinic medical staff could add to the rising number of lawsuits.

Daygan Eagar, spokesman for the Rural Health Advocacy Project, said budgets in provincial health departments had “flat-lined”.

His organisation has been told that Eastern Cape does not have money to employ newly qualified doctors who were recipients of provincial bursaries and are obligated to work for the department.

Eagar said Mpumalanga’s health department had said it would be able to start hiring community-service doctors in the new financial year.

He said North West hospitals were badly affected by the freeze.

“Things are bad. Non-emergency surgeries, such as knee replacements, have been cancelled.”

The Eastern Cape’s Zithulele Hospital, once a beacon of hope among failed state hospitals, is unable to hire the five community-service doctors it needs.

Although the Health Department is training 1900 doctors a year, up from 1400 a few years ago, it is not known how it will be possible to place them.

Doctors cannot qualify without completing a period of state service.

Eagar said that, although the department had accelerated the training of medical staff, it did not appear able to employ them.

Health Department spokesman Joe Maila said: “There is no policy decision to freeze posts.

“The filling of posts is based on prioritisation in terms of service needs balanced against the availability of funds.

“On this basis, clinical, nursing and technical posts are prioritised. The financial space to fill posts has become tighter in view of global economic pressures.

“Delegated authority to make decisions on filling posts in some provinces has been elevated to senior levels. This has sometimes been interpreted as ‘freezing of posts’. Registrar posts in KwaZulu-Natal have not been frozen,” Maila said.

Western Cape health department spokesman Marika Champion said: “When faced with budget constraints, the department has developed a system giving institutions’ heads the opportunity to prioritise.”

Written by Katharine Child

Published Times Live

Cape Town leads the way in stimulating local technology startups.

400 applicants for Cape Town accelerator

Applications have closed for a new accelerator programme for financial technology start-ups based in Cape Town and backed by Barclays Africa and US accelerator Techstars, with nearly 400 companies from around the world applying to take part. By Duncan McLeod.

Yossi Hasson

Yossi Hasson

Applications have closed for a new accelerator programme for financial technology start-ups based in Cape Town and backed by Barclays Africa and US accelerator Techstars, with nearly 400 companies from around the world applying to take part.

The Cape Town-based Barclays Accelerator, which joins similar Barclays-backed programmes in New York, London and Tel Aviv, hopes to find 10 innovative businesses that are either based in Africa or focused on Africa to take part in an intensive 13-week programme.

Former Synaq MD Yossi Hasson is heading up the Cape Town accelerator as MD. He says it is hoping to sign on three or four companies from outside Africa, three or four from Africa outside South Africa and two or three from South Africa itself.

The focus will specifically be on fintech start-ups, says Hasson. Barclays hopes to use the programme to work with technologists who could end up disrupting the financial services industry. Businesses that are accepted into the accelerator will have access to senior Barclays executives, have early access to the bank’s technology and systems, and be given access to its global networks.

Those accepted into the programme will have access to any of the Barclays accelerators and can raise funding in any of those networks.

Applications, which opened in mid-November 2015, closed on 17 January. Hasson says almost 400 applications have been received from around the world. The number is over 400 if one includes those who applied to participate in both the Tel Aviv and Cape Town programmes, he says.

These applications will now be filtered, with an interview process to follow soon. “We have received some very interesting applications from a wide range of countries,” says Hasson.

Successful applicants will go through the same programme as Techstars in the US, with the only difference being the added involvement of Barclays in the selection process and in mentoring the start-ups.

Techstars, which describes itself as a mentorship-driven start-up accelerator, was founded in 2006 by David Cohen, Brad Feld, David Brow and Jared Polis and has to date taken 762 companies through its programme. The business has overseen more than US$2bn in funding to start-ups, with 90% of them still operationally active.

The Techstar founders realised that entrepreneurs needed more than just capital to be successful, says Hasson. “They built the idea of taking 10 start-ups and putting them through an intensive three-month programme where they get access to seasoned entrepreneurs as mentors and industry experts.”

Successful applicants must relocate to Cape Town for the duration of the 13-week programme

Successful applicants must relocate to Cape Town for the duration of the 13-week programme

The first month of the programme involves intensive mentorship, while the second month focuses on taking feedback and advice received and building traction by adapting strategy and, where necessary, changing the product or service being developed.

The final month is about raising capital — focusing, for example, on how to pitch to venture capitalists. This leads to a “demo day”, where the start-ups pitch their business to a large audience made up of, among others, venture capitalists and angel investors.

Those who go through the programme successfully become part of the broader Techstars network. “You become an alumnus for life,” says Hasson. “You can raise capital in any of the countries [where it operates] and have access to a network of more than 5 000 mentors.”

Techstars will invest US$20 000 (about R330 000 at the time of writing) in successful applicants. This money will help pay for start-up teams to be physically present in Cape Town for the duration of the programme, which is one of the requirements of acceptance. In return, Techstars takes 6% equity in the start-up.

A further $100 000 in the form of a convertible note (short-term debt that converts into equity) is also available from the Barclays Seeker Fund.

Who is likely to be chosen to join the programme?

“The main thing we are looking for is a strong team,” says Hasson. “We do want to see you have some traction, too — having a prototype, or having some customers, for example, not just coming in with an idea. We can’t accelerate just the start of an idea; you need some momentum already. We are also looking for businesses where having access to Barclays can really unlock tremendous value.”

The idea, Hasson says, is to use the programme as an opportunity to “raise real money and globalise African-focused fintech businesses”.  – © 2016 NewsCentral Media

AS A BUSINESS LEADER, ASK YOURSELF THE FOLLOWING QUESTIONS:

MB informal picAre you able to get to all those projects, which you know will add value to your business?
Are you able to find time to address and resolve issues in your business – problems, opportunities, whatever?
Do you have senior people to whom you can delegate to, who are able to focus on the specific issue, for long enough, while still delivering on their core responsibility?
Are you able to keep pace with the changing market environment?

If you have answered No to any of these questions, you should be talking to us.

We will come into your business, work with your people, understand the issues, offer alternatives, provide concentrated focus to get the job done and then move on.

Call me on 0834072222 for a confidential, no obligation chat.

National Health Insurance

The South African public generally and the medical devices and healthcare sectors specifically have reason to be skeptical about the government’s ability to implement national health insurance in this country.  Over the past twenty years we have seen a decline in service and quality in public health, with increasing costs in the private sector.  Not so unique some would say given inequities of the past and ineptitude of the present government.  Animosity between the public and private sectors also doesn’t help the situation.

Never the less, things are happening under the stewardship of the current Health Minister, Dr Aaron Motsoaledi.  In a review of what’s changed over the past year in healthcare legislation we see that a lot has changed, most of it has been in the background, behind the scenes, so to speak.  The hospital revitalization plan has progressed, increasing management capacity and financial controls have been improved, and eleven NHI pilot sites have been established.

Meanwhile in a survey of the most influential business leaders in the Medical Device sector reflect that their operating environment has changed dramatically, while simultaneously supporting their current business models as being optimal and in no need of change!  Quite a contradiction, but in keeping with the “wait and see” attitude of most current players in the sector.  The question remains to be seen if they are able to respond to change – when they recognize it.  Are they going to be able to defend their market position against new entrants, more attune to the changing healthcare needs and market dynamics created by Healthcare Transformation.

Time will tell; but sound advice for today is to build a business model that is agile, able to capitalize on market shifts, whilst being resilient enough to succeed in today’s environment.  This requires a business of parallel capability – one focussed on “business as usual” the other looking to the future, developing and testing future business models – “Business Unusual” perhaps.

Mark Banfield is an independent consultant in Medical Devices and healthcare technology sectors.