May 17, 2020

What Baseball Can Teach the Health Care Industry about Big Data

Big Data
Cloud Services
Big Data
4 min
The longest thrown ball was accomplished in 1957 by Glen Edwards Gorbous, a Canadian who was in the Majors from 1955-1957.
Baseball has never been a simple sport and now, its become an even more complicated science.

In the early days of Babe Ruth and Willie Mays, baseball m...

Baseball has never been a simple sport and now, it’s become an even more complicated science.

In the early days of Babe Ruth and Willie Mays, baseball managers followed a handful of truths to strategize a win: use right-handed pitchers against right-handed batters, left-handed pitchers against left-handed batters, don’t hold the runner at first with two outs and a left-handed batter, and no left-handers at infield positions except for first base.

Defensively, it was also just as simple. Depending on if the batter was right- or left-handed, the shortstop would shift his position to either side of the second base.

Over time, the center fielder began to move his position, too – toward the right field while the right fielder guarded the line and vice versa during pitches. Gloves also got bigger.

The year 1964 saw the biggest defensive shift when Cleveland manager Lou Boudreau moved his shortstop to the right of second base against the legendary Ted Williams of the Boston Red Sox. Since then, the sport has never been the same.

Defensive shifting has become “epidemic” in the world of baseball, according to the Wall Street Journal, with Major League teams “shifting” 8,134 times last year, compared to just 2,357 times in 2011.

The approach to enhance optimal positioning on the field, however, is no longer being relied upon by intuitive hunches or reviews of previous games; rather, baseball has turned to big data to predict the best solution based on elements of a specific game.

One reason why defensive shifts are taking over the field is because of the sport’s transition to better technology. Major League Baseball has figured out what it needs to be successful and is taking every measure to obtain that success: clusters of cameras that measure depth and movement, computer-imaging, and software that track the movements of players and the ball.

Today, with access to so much data, the cost-benefit analysis is making teams play the odds.

“If you’re not going to embrace some of this stuff, you’re not giving your team the chance to win that you should,” Orioles Manager Buck Showalter told WSJ.

But what does any of this have to do with health care? Well, everything.

Comparisons between baseball and the health care industry are shown in this chart. 

Health Care’s Big Data Integration

The health care industry only recently began to integrate big data into their systems, and because of this newfound change, a lot of uncertainty still remains: how to realize its value for quality care, bending the cost curve, how to share it and how to secure it.

Rising health care costs and policy changes are forcing health care to transform into a system that is more and more rewarding to providers for quality of care, as opposed to just volume. And that is where big data comes into play.

Steven Escaravage and Joachim Roski of Health Affairs Blog have spent some time working on big data projects with federal health agencies and other departments and what they have found is an overall lack of discipline, “unexpected in taking full advantage of big data’s potential.”

Many health care organizations are eager to get started on a big data project, and in their haste, do not consider what problems to focus on when compiling analytics. Additionally, organizations tend to stick with the data that is easily accessible and familiar, the duo reported, providing only a partial picture.

“Health organizations will get the most from big data when everyone sees the value and participates,” wrote Escaravage and Roski. “Too often though, initial analytics projects may be so self-contained that it is hard to see how any of the results might apply elsewhere in the organization.”

The health care industry has the potential to realize $300 billion in annual value by leveraging big data, according to a 2011 McKinsey report, but getting there will take trial and error.

This is where baseball comes into play.

Lessons from the Field

At this point in time, the baseball industry has big data locked down. Baseball can gather all sorts of data from the field – the type of pitch, the speed of a pitch, the location of a pitch to how the batter reacted to the pitch, which direction it was hit in and how hard it was hit.

Health care needs to move closer to optimal positioning and defensively shift to obtain this level of diverse analytics.

Much like the pitcher-batter dynamic, patient-doctor relationships can benefit greatly from the use of big data. The health care industry needs to find ways to quantify the aspects of those relationships that can easily be measured and quantified.

Health care organizations are like the rookie playing in his first Major League game – they have a clear understanding of how the game works but lack the experience of their senior counterparts.

It’s all about balance: understanding where one’s data comes from and an approach that starts with a problem, not a solution.

As Babe Ruth once said, “Every strike brings me closer to the next home run.” 

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Jun 20, 2021

Medical device companies: how to prepare for Brexit

Ed Ball
6 min
Ed Ball, Senior Associate at RQM+ , explains how medical device companies can prepare for post-Brexit compliance

Over the last decade, medical device businesses have been no strangers to regulatory changes and new compliance requirements. Companies with devices in the EU market have been working hard to achieve conformity with the requirements of the EU Medical Device Regulation 2017/745 (MDR) and In Vitro Diagnostic Regulation 2017/746 (IVDR), but the UK’s exit from the EU, effective as of 1st January 2021, demands yet another change: to comply with the new UK regulatory regime.

The Medicines and Medical Devices Act passed into law on 11 February 2021 does just that; it enables the UK to build its own regulatory system, although when this new framework will be fully in place is not yet known.

The transition to the UK’s new regulatory regime officially began on the 1st of January 2021, and with it a series of deadlines and phases that medical device manufacturers exporting to GB and Northern Ireland would do well to take close notice of. During the transition period, the UK Medical Devices Regulations (UK MDR) 2002, not to be confused with the EU MDR, will continue to apply in England, Scotland and Wales, whilst CE marked medical devices will still be accepted up to 30th June 2023.

The conformity assessment processes defined in the UK MDR 2002 (as amended) will require that medical devices carry the UKCA mark for entry in the GB market or the UKNI mark for entry in Northern Ireland (where the devices are not CE marked for the EU). In Northern Ireland, where the rules for placing a device on the market differ, the EU MDR and IVDR will apply in 2021 and 2022 respectively, in line with the EU’s implementation timeline. 

This easing-in period of transition is valuable time that should be used productively by manufacturers to ensure that they get up to speed, keep up with relevant updates and prepare strategies and product portfolio for the next phase. To do this, businesses should make sure they consider the following areas as they assess their strategy for UK market access:

Potential Overlap with EU MDR and IVDR
Medical device manufacturers have been working to implement measures to ensure they comply with EU MDR and IVDR for quite some time. The experience, processes and objective evidence that they have gathered in these efforts are certain to be of use when applying for UKCA marking. 

Rigorous Planning
Product portfolios and new product pipelines should be evaluated against both overall compliance risk and commercial and strategic value. By identifying the regulatory compliance status for each product for the UK market and the efforts required to maintain that compliance, manufacturers can plan to use the grace period up to June 2023 to complete their activities. These plans should also be evaluated in consideration of the commercial importance of the individual products to help prioritise the workload. This may well result in the decision to discontinue certain products in the UK or to introduce new products on the UK market ahead of other markets.

Engage with Approved Bodies
This activity cannot take place too soon; as of the 1st of January 2021, UK organisations that were acting as EU Notified Bodies have become Approved Bodies in the UK, while EU Notified Bodies are no longer able to provide conformity assessments under the UK regulations. As there are currently only three UK Approved Bodies offering this service, there is a very real risk that latecomers will struggle to find a UK Approved Body to carry out the conformity assessment required to attain their UKCA mark in time.

Authorised Representatives
Just as EU Notified Bodies are no longer relevant to pursuing UK certifications, UK-based Authorised Representatives are no longer valid when CE marking against the MDR or IVDR. Manufacturers using UK-based EU Authorised Representatives must switch to an EU-based Authorised Representative.

For the UK market, the role of the EU Authorised Representative is also no longer applicable. Non-UK manufacturers must have a UK-based Responsible Person (UKRP), which is equivalent to the EU Authorised Representative in terms of roles and responsibilities. Only one UKRP may be appointed, unlike EU Authorised Representatives, and they must have a registered place of business in the UK in order to register with the MHRA. Approved Bodies may be able to provide details of organisations acting as UKRPs and once this role has been assigned it will be critical for manufacturers to determine exact procedures for managing documentation and that clear communication channels are established. 

Labelling and Import/Export
New UK regulations require that medical devices bear a UKCA mark in addition to the name and address of the UKRP for non-UK based manufacturers. Manufacturers who use the same products/packs for the EU and UK markets will need to consider the impact of adding more content to their labels in terms of usability for the supply chain and end-users. 

While CE marking and certificates will continue to be recognised by the UK until June 2023, import/export administration is likely to change and become more burdensome. Manufacturers using separate products for GB (UKCA) and the EU and Northern Ireland (CE marked) will need to plan for how to ensure that the CE marked product is not shipped to GB post June 2023. Ensuring that processes and resources are in place to deal with developing situations will help manufacturers hit the ground running.

Clinical Investigations
Many businesses will find that clinical investigations are carried out across multiple sites, some of which are outside the UK. In these instances, manufacturers will do well to have a plan for implementation and management of investigations, in compliance with local requirements. It is likely that the MHRA will also continue to update their requirements for clinical trials in the UK.

Data Protection and Standards
New tensions are emerging between the EU and the UK concerning UK data protection rules and the EU’s General Data Protection Regulation (GDPR), suggesting that maintaining ‘equivalency’ may involve a number of different phases.

Compliance with applicable standards also requires close attention; the list of designated standards for medical devices issued by the UK’s Department for Health and Social Care is based on the list of harmonised standards published in the Official Journal of the EU, which in turn are harmonised to the MDD, AIMDD and IVDD. More recently published standards, however, have not been harmonised to the latter European directives and are thus not in the UK’s designated list, despite being considered state of the art. It would be prudent for manufacturers to monitor the state-of-the-art standards and apply where applicable, rather than rely on superseded and outdated standards.

As the UK moves into a new regulatory regime, medical device manufacturers who have already invested time and resources to comply with EU MDR and IVDR can use this to attain their UKCA mark. However, a dynamic compliance environment combined with the new onus relating to export policies means that close attention needs to be paid on numerous fronts. Keeping pace with this changing environment will ensure that manufacturers face the future with confidence and do not lose important space on their markets.

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