Showing all posts written by April White

On January 31, 2018, the European Commission adopted a legislative proposal with the aim of strengthening EU cooperation among Member States when conducting a Health Technology Assessment (HTA) of new medicines and certain new medical devices. The European Commission Fact Sheet explains that HTA is a procedure for assessing the added value of new medicines and medical devices, for example, assessing whether a new scanner will lead to a better diagnosis or whether a new surgery will improve the patient’s treatment.

BEUC, the European Consumer Organization, explained in a press release that at the moment, around 50 national and regional HTA authorities provide Member States with clinical data, however, work carried out by one authority is often replicated by another, leading to inefficiency in EU health systems.

The Commission’s proposal establishes four areas of joint work between Member States at EU-level:

• Joint clinical assessments focusing on the most innovative health technologies with the most potential impact for patients;
• Joint scientific consultations, or “early dialogue,” whereby developers can seek advice from HTA authorities;
• Identification of emerging health technologies, commonly referred to as ‘horizon scanning’, to identify promising technologies early; and
• Voluntary cooperation on other areas.

In a press release, the Commission added that “manufacturers will no longer have to adapt to different national procedures.” Not all work will be done jointly, the Commission’s press release indicates that individual EU countries will continue to be responsible for assessing non-clinical (e.g. economic, social, ethical) aspects of health technology, and making decisions on pricing and reimbursement. Thus, device manufacturers will still need to work with each Member State to determine pricing and reimbursement.

The Commission’s Q&A on the proposal explains that the joint clinical assessments will not affect market approval as they will only occur after the medical devices have obtained a CE mark. The Q&A also notes that HTA does not interfere with the conformity assessments of medical devices.

The Commission asserted in the Q&A that those benefiting from cooperation would include:

• Patients, who may benefit from a faster uptake of promising innovative technologies;
• Member States, whose national authorities will be able to pool their expertise and avoid duplication of efforts on clinical assessments, making better use of human and financial resources; and
• Industry, including SMEs, who will benefit from clearer rules and greater predictability for their business planning, and cost savings.

In a statement to EURACTIV.com, Yannis Natsis, Policy Manager for the European Public Health Association, cautioned:

A European approach must improve on the current system and deliver meaningful innovation and affordable treatments. There must not be the slightest doubt that cooperation would weaken it or make the assessments less rigorous.

A timeline proposed by the Commission indicates that the proposal could be adopted by the European Parliament and the Council of Ministers in 2019, become applicable three years later, and then have a further three-year transitional period to allow for Member States to phase-in the new system.  The Q&A provides an example of a phase-in, suggesting the system could perform 10 to 15 joint clinical assessments in the first year of operation and reach around 65 assessments towards the end of the transitional period.

The ECRI Institute released new guidance in its article: “Ransomware Attacks: How to Protect Your Medical Device Systems” on May 18, 2017.  The report recommends various protective actions for hospitals to take and points to critical differences in the protection of medical device systems as opposed to general hospital systems.

According to the report, ransomware makes data, software, and IT assets unavailable to users.  The report describes ransomware as using the encryption of data to hold systems hostage, where the hacker promises to give the victims access to their data if a ransom is paid.  One previous ransomware example reported on the Knobbe Medical Device Blog was the WannaCry virus, a ransomware that caused disruptions for several hospitals in the United Kingdom.  The International Business Times reported that security researchers had found that the WannaCry ransomware was not limited to computers but also capable of exploiting medical devices.

The ECRI Institute report explains that an IT department can use new security patches for some medical device systems; however, some systems will remain susceptible because they are based on an older version of an operating system and can’t be upgraded or they have not been validated for clinical use with the latest security patches. 

The report includes a list of dos and don’ts for quickly responding to emerging threats.  The “Dos” mentioned in the report include:

• Identify medical devices, servers or workstations that may be affected.
• Contact the device vendor. 
• Request written copies of the manufacturer’s recommended actions for dealing with a current ransomware threat. 

The “Don’ts” mentioned in the report include:

• Don’t overreact.
• Don’t install unvalidated patches.  Unvalidated patches can make medical devices faulty or inoperable.  Ask the manufacturer for documentation of the validation.

The ECRI Institute is a nonprofit organization that has its U.S. headquarters in Plymouth Meeting, Pennsylvania.

Despite a drop in the second quarter of 2016, medical device funding is expected to finish stronger this year than in 2015.  CB Insights has released a report on the funding and deal activity within the medical device industry since 2012.  CB Insights reports that “after hitting a 4-year high of $1.5 billion in the second quarter of 2014, funding to medical device startups has sobered considerably.”  Funding in 2014 was elevated by a $172 million Series G round secured by California based Proteus Digital Health.  Overall, the medical device industry is on track for a modest increase in deals and dollars to private companies in 2016, after seeing a decline in both in 2015.

As of August 8, 2016, funding and deal activity have reached $2.1 billion and over 288 deals. At the current rate, total year funding would reach $3.5 billion and total year deal count would reach 476 deals.  The funding has been bolstered by $75 million in Series C funding secured by California based Acutus Medical in March 2016 and recent funds raised by Minneapolis based CVRx, $93 million in August 2016.

The first and second quarters of 2016 are among 5 of the last 10 quarters to have 120+ deals. Funding in the first quarter of 2016 managed to break $1 billion, a feat that didn’t occur in 2015.  However, the second quarter’s slip to $757 million saw the first sub $800 million quarter since the first quarter of 2015.

The deal and dollar share by stage for 2016 looks to be similar to those for the last four years with early-stage deals, including Seed/Angel and Series A, making up 29% of total deal share to-date. The top three “Most Active Early-Stage Medical Device Investors” are reported as Germany based High Tech Gruenderfonds, Memphis based ZeroTo510, and Philadelphia based Ben Franklin Technology Partners.  Interestingly, “Other” funding rounds have been trending up and currently represent the largest share of deals at 42%.  “Other” includes corporate minority rounds, VCs, and convertible notes.  The top medical device investor overall is reported as New Enterprise Associates with Versant Ventures a close second.

CB Insights reports the top most well-funded medical device startup as Theranos, securing $400 million in total funding. Theranos was recently sanctioned by the U.S. Centers for Medicare & Medicaid Services (CMS) and banned from receiving Medicare and Medicaid payments.

Each of the top five has raised upwards of $250 million.  However, the funding figures exclude debt rounds and lines of credit.

The medical device industry has been struck by a wave of uncertainty in the wake of the United Kingdom’s (UK) historic vote to leave the European Union (EU).  Until the breakup becomes official, British legislation should remain fully aligned with European rules and CE marked products should be able to move freely across the Channel.  The UK remains a member of the EU until the UK invokes Article 50 of the Lisbon Treaty, followed by a two year time-frame for negotiations regarding conditions of the exit and future relationships, with the possibility of an expanded time-frame of 5 or even 10 years.  The UK’s National Standards Body, known as British Standards Institutions (BSI), released a statement stating:

For now, it’s business as usual and most importantly, we we would like to assure you that BSI will continue to provide EU market access as we have done since the inception of the three EU Medical Device Directives.

The UK has EU Medical Directives transposed into national law.  So even as the UK leaves the EU, these laws will remain in place unless the UK government decides to change them.  The timing of the exit could affect the UK implementation of the new EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR), which address pre-market conformity with requirements, post-market oversight, and traceability of devices throughout the supply chain, among other things.  The EU could potentially approve the MDR and IVDR by September 2016 with enforcement beginning in 2020.

At present, medical devices can be marketed throughout the European Economic Area (EEA) once they have a CE Mark issued by any Notified Body.  A CE Mark indicates that the product meets the requirements of the applicable European Commission (EC) Directives.   The future of UK based Notified Bodies is unclear, but in its statement, BSI expressed confidence that it will continue to be recognized as a Notified Body for Medical Devices after UK’s exit from the EU.

Another point of uncertainty involves Authorized Representatives, also known as EC Reps, which are legal representatives that provide access to the European market to non-EU manufacturers.  The future of UK based Authorized Representatives is up in the air, but Sinead Keogh, Director of the Irish Medical Devices Association (IMDA) sees the possibility that UK based Authorized Representatives may not be eligible to represent manufacturers within the EU forcing companies to establish Authorized Representatives within another EU state.

Ronald Boumans of Emergo Group sees four options for the UK upon the UK’s exit from the EU:

1. Become part of the EEA or European Free Trade Association (EFTA) similar to Norway, Iceland, and Liechtenstein.  The free movement of goods will remain under the CE Marking of the applicable categories of products and Notified Bodies and Authorized Representatives can keep working from the UK.
2. Set up a mutual recognition agreement (MRA) similar to ones the EU has with Australia, New Zealand, and Switzerland.  Depending on the agreed upon conditions, this option may allow for Notified Bodies and Authorized Representatives to continue operating from within the UK.

The Food and Drug Administration has proposed a new policy for earlier public notification of medical device safety issues.  These notifications will be in addition to the recall notices, safety communications, and press releases the FDA already puts out.

In the proposed guidance, which is not yet final, the FDA notes the “need to notify the public about emerging signals that the Agency is monitoring or analyzing, even when the information has not been fully analyzed, validated, or confirmed, and for which the Agency does not yet have specific recommendations.”  However, the FDA notes that “[p]osting this information does not mean that FDA has concluded there is a causal relationship between the medical device and the emerging signal.  Nor does it mean that the FDA is advising patients or health care professionals to discontinue or modify use of these products.”

Examples of emerging signals given in the guidance include: “a newly recognized type of adverse event associated with a medical device, an increase in the severity or frequency of reporting of a known event, new product-product interactions, device malfunctions or patient injuries potentially related to improper device use or design, or a reduction in benefit to the patient.”

In the guidance, the FDA notes that a decision to issue a public communication about an emerging signal should only come when:

• the information represents a new, potentially causal association, or a new aspect of a known association (e.g., increased rate or severity of even or reduced benefit), between a medical device and one or more adverse events or clinical outcomes;
• the available information is reliable and supported by sufficient strength of evidence; and
• the information could have important clinical implications for patient management decisions and/or could it significantly alter the known benefit-risk profile of the device.

The guidance outlines that once an emerging signal is communicated, updates to the communication should be posted to the FDA website at least twice per year until a more formal and finalized communication is issued.

Comments on the proposed guidance should be submitted by February 29, 2016, to ensure consideration.  Instructions on how to submit comments can be found here.