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Software as a medical device growth

The software as a medical device market is expected to reach US$ 86,451.62 Million in 2027 from US$ 18,488.00 Million in 2019; it is estimated to grow at a CAGR of 21.9% from 2020 to 2027.

The global software as a medical device market is segmented by device type, application, deployment type, and geography. Based on device type, the market is segmented into PCs/laptops, smartphones/tablets, and wearable devices, and in 2019, the PCs/Laptops segment accounted for the largest market share. 

The segment is expected to continue its dominance over the forecast period owing to the introduction of upgraded laptops with smart sensors incorporated in them. Furthermore, the laptops and computers are now being evolved into complex hardware systems that can act as an integrating tool as well as perform various monitoring and advance healthcare diagnostic activities through their new in-built features. 

On the other hand, the growing adoption of smartphones and the interest of software developers toward building smartphones compatible healthcare apps to help it act as a medical device are expected to lead the smartphones/tablets segment toward the highest CAGR during the forecast period.

Medical devices including software, are regulated in the EU market by the EU Medical Device Regulations (MDR), and in the US Market by the FDA.

What is Software as a Medical Device?

The EU Medical Device Regulations (MDR) defines medical device as:

‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the following specific medical purposes:

  • diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
  • investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
  • providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

In effect any software which aids in the diagnosis, prevention, monitoring, prognosis treatment or alleviation of disease is classified as a SaMD under MDR. This is all dependent on the manufacturers definition of the intended use of the product.

What are the EU Medical Device Regulations (MDR)?

The new Medical Devices Regulation (2017/745/EU) (MDR) and the In-vitro Diagnostic Medical Devices Regulation (2017/746/EU) (IVDR) bring EU legislation into line with technical advances, changes in medical science, and progress in law making.  

Regulation 2017/745 on Medical Devices (MDR) and Regulation 2017/746 on In-Vitro Diagnostic Devices (IVDR) were agreed at a political level between the three relevant European institutions  (the European Council, the European Parliament and the European Commission) and entered into force in May 2017 following publication in the Official Journal of the European Union. The Regulations have a staggered transitional period with some aspects becoming legally binding after 6 months of entry into force. 

The MDR was due to become fully applicable on 26 May 2020 after a three-year transition period. However, due to the global outbreak of Covid-19, full application of the MDR has been postponed and will become fully applicable on 26 May 2021. The IVDR will be fully applicable on 26 May 2022, after a five-year transition period.

Medical software that falls under the scope of the MDR is considered a medical device and needs CE marking.

Who is a manufacturer?

Definition of a manufacturer: means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trade name.

Obligation on manufacturers?

The obligations of the different actors and their relations are now clearly stated in the Regulation.

The manufacturers must document the intended use

According to Article 10, manufacturers shall have systems for risk management (paragraph 2) and quality management (paragraph 9); conduct clinical evaluations (paragraph 3); compile technical documentation (paragraph 4); and apply a conformity assessment procedure (paragraph 6). Manufacturers are also responsible for their devices once they are on the market (paragraphs 12, 13, 14). They must have systems in place to cover their financial responsibility for harm caused by defective devices (paragraph 16).

Every manufacturer shall have a named person responsible for regulatory compliance (Article 15).

Once they have completed all these obligations, manufacturers shall draw up a declaration of conformity (Article 19) and apply CE marking to their devices (Article 20).

Manufacturers outside the EU/EEA shall have a contract with an authorised representative inside the EU/EEA4 (Article 11).

Classification of Medical devices.

A new rigid, software-specific classification rule pushes devices into the higher risk classes II or III (Rule 11). To date, software as a medical device (SaMD) has often been classified as a class I product. Under the MDR, this will change drastically. Almost all software as a medical device will be up-classified into higher risk classes.

Rule 11 (MDR):

Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:

  • death or an irreversible deterioration of a person’s state of health, in which case it is in class III; or
  • a serious deterioration of a person’s state of health or a surgical intervention, in which case it is classified as class IIb.

Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.

All other software is classified as class I.

*Class 1 is effectively impossible under MDR, as the definition for 2a includes “used for treatment or diagnosis” which is the same criteria to qualify as a SaMD.

Impact of MDR on QMS

All medical devices, whether currently certified to a European Medical Directive or yet to be certified, will need to comply with the requirements of the MDR to be certified under the MDR. The MDR requires manufacturers to demonstrate an effective QMS. Therefore, to receive certification to the MDR, you must have a compliant QMS within the transition period, as set out in Article 120.

While MDR is not specific on what certified and audited QMS is in place, in effect ISO13485 is the only current QMS available that can be certified at present.

Class II or III: Medical device manufacturers need to get their CE marking approved by a Notified Body (NB). Instead of self-assessment, the NB assesses the device conformity and approves the CE marking with the NB-specific 4-digit identification number.

Can a manufacturer outsource Software Development?

Yes, outsourcing to a software development company certified to ISO13485 is possible, and software and documentation generated during development can be imported into the manufacturers own QMS and technical file. Third parties do not take on the manufacturers legal responsibilities, however their systems and processes under ISO13485 may also be audited on behalf of the manufacturer.   

Greenfinch Technology, part of the TEKenable Group is a Dublin based company, providing healthcare software development services for creating medical apps classified as Software as a Medical Device (SaMD) under the medical device regulations. Our team brings a wealth of experience in using the Microsoft technology stack and other technologies. We use the IEC 62304 software development process, helping to deliver software applications conforming to ISO 13485 regulations. Greenfinch Technology is an Irish software development company that specialises in SaMD projects.

TEKenable acquires Greenfinch Technologies

Announcement

Digital evolution and services company, TEKenable has announced its acquisition of Greenfinch Technology, an Irish Microsoft Gold partner specialising in Cloud Solutions, Mobile applications and software for Medical Devices.  The acquisition will accelerate TEKenable’s growth, allow it to enter new markets, will bring additional scale and capability to TEKenable’s Low Code Cloud Solutions practice and significant IP in new market sectors, new technology solutions and rapid application delivery. Combined the businesses will have over 90 employees, 100 customers, projected FY revenues close to €8M with operations across Ireland, UK, Spain and Middle East.

Headquartered in Dublin, Greenfinch has a team of 26 employees.  The company’s expertise aligns perfectly with TEKenable’s services.  Greenfinch has built up significant expertise in Microsoft technologies (Xamarin Mobile Platform, Microsoft Dynamics, Microsoft BI) as well as its own products in workflow automation and compliance.

TEKenable MD Nick Connors said:

The acquisition of Greenfinch is a significant development for our business and brings together a dedicated and highly skilled team delivering ‘Low Code’ cloud platform solutions which will establish us as one of the leading providers of cloud application services in both Ireland and the UK.”

TEKenable, founded in 2002 by Nick Connors and Peter Rose is an innovative technology company focused on delivering digital evolution through Low Code platforms to mid and large-scale enterprises both in Ireland, the UK and Middle East. Irish owned and committed to transforming forward-thinking public and private sector business into a fully digital business in the cloud. As the experts in the very latest Low Code ‘Cloud’ platforms, the company works with organisations to accelerate their digital capability in order to realise a real business advantage. TEKenable is Gold Microsoft Partner and a Deloitte Fast 50 recipient in 2019.

Dermot Reid, MD of Greenfinch said: 

We are delighted to join the team at TEKenable which will enable us to scale our offerings and capabilities and deliver our services to an even greater range of clients.  The acquisition is very good news for our customers who now have access to the breadth of Cloud services that both companies have to offer.  We are thrilled to become part of one of Ireland’s most progressive companies.”

Greenfinch founder Dermot Reid and fellow director Brendan Thomas and the executive management team will join the TEKenable team, focusing on continued growth of the business and to oversee the successful integration of the two companies.

TEKenable CTO Peter Rose said:

This is an exciting time for TEKenable, Greenfinch, our respective teams, partners and customers.  Together we will work with our forward-thinking clients to transform their businesses in the cloud.  The combined businesses will make us one of the most capable Microsoft specialists in Ireland and the UK ”.

About TEKenable

TEKenable is an Irish technology company delivering digital evolution through Low Code platforms to help companies build real business advantage. As market demands continuously change, the company blends innovative thinking and breakthrough technologies to produce game changing results through improved cost savings, operational efficiencies and enhanced customer experience.

About Greenfinch

Greenfinch Technology is an Irish Microsoft Gold partner specialising in Cloud Solutions, Mobile applications and software for Medical Devices  providing world class Microsoft based software solutions that transform businesses.  Greenfinch has built significant IP in a Low Code software product suite that accelerates Digital transformation for its clients across Ireland, UK and Spain

Founded in 2008, the company has grown to 26 staff  with expertise in product development, software development, cloud solutions, IoT, security and technology delivery. Greenfinch has offices in Ireland, UK and Spain.

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