May 17, 2020

The benefits of integrating organizational development into your health care practice

Hospital Leadership
Hospital Operations
Hospital Leadership
Hospital Operations
Admin
5 min
Organizational development serves to clarify each member’s role within a health organization.
How do you take an unruly thing like organizational development and have it succumb? How do you rely on it to engage and inspire the work force? How doe...

How do you take an unruly thing like organizational development and have it succumb?  How do you rely on it to engage and inspire the work force?  How does it build team engagement and customer partnerships, and how does it benefit the patient and the provider?

What is organizational development?

Organizational development (OD) is the aggregate of an organization’s knowledge, strategy and practices, and the use of those to foster members’ behaviors and results. The result is effective change. 

RELATED TOPIC: How NHS SBS is transforming health care procurement

OD serves to impact the company’s and the individual’s performance and development—it propels the organization and its individual members to be more effective and efficient (expert) at:

  • anticipating, initiating and managing change
  • solving problems via effective strategies, action plans & communication
  • improving performance
  • attaining desired results & goals
  • anticipating, initiating and managing future change & continuous improvement

(Note the continuous loop there.)

OD includes: strategy and planning; leadership structure; talent development; continuous improvement; operational structure and process design; performance management; coaching and mentoring; team building; communication strategy. These are some of the invariable raw ingredients. How they are cooked, however, varies from one organization to another, and this cooking process is the art behind the science. It is what gives an organization its own flavor, its own personality and its own culture. 

Further, OD serves to clarify each member’s role within the organization: what that role is, its purpose, and how to accomplish it. Armed with this knowledge, each member has the opportunity to master their role and then expand it: and building on that, have increasing influence in the organization.

OD works on the assumption that when individuals have a comprehensive knowledge and appreciation of their organization’s goals, expectations, and procedures, they will engage more, take more responsibility, collaborate more, and achieve more. 

Why is OD important?

An organization is a system, comprised of individual parts working alone and in concert with others. Rarely can there be a failure or success of one part without a corresponding effect on others and/or the whole system. 

Further, when these “parts” happen to be people, they are inevitably influenced by how the organization lives and behaves: the organization’s structure, personality, practices and processes influence worker behavior, motivation, adaptability, engagement and development.  When an individual is not aligned and working in concert with the whole, or vice versa, both suffer. But when the converse is true, there is symbiosis—everyone benefits from the other. 

RELATED TOPIC: Where is the future of the health care supply chain headed?

Essentially OD, when done right, makes the inevitable and the challenging change—a group effort amongst internal and external willing participants. And think how much easier change efforts are when undertaken by a group playing nice and playing the same game, versus when one guy is playing volleyball and the spiker has gone off to swim practice because she never much cared for volleyball. 

OD engagement in health care

How do we convince health care workers (clinicians and others) to bother, never mind engage, with OD? 

It is first necessary to establish the identity of the organization, what it stands for, and what it means to accomplish. Whether in a global company or a small concierge practice, identity matters. Further, if that identity can be developed and groomed collaboratively by multidisciplinary and multi-level colleagues, then the identity will be, among others things, more true, more inspirational, and more engaging. That, rather than not!

The “how” question is also important—how will the organization do what it means to do? Ethical, moral, and legal goes a long way, as does: collaborative decision making; focus on team development and professional growth opportunities for all members; engaging communication strategies where all members, internal and external, are effectively/appropriately ‘in the know’. A mission, vision, values statement, if developed in partnership with multiple stake-holders, will often hit the target—why are we here, and why does each one of us belong here? And to do what?

RELATED TOPIC: How pharma supply chains need to change for the future

A vital question, and an invariable misstep in the health care arena, is how to marry the clinical mindset, the altruistic sole, the caregiver, with the business, the logistics, and the finance of treating patients. How to heal people, and make a profit? That’s a tough one for clinicians. For many it’s even inappropriate. The answer—the bridge—is often found in this realm: an ever evolving dialogue about how can we empower one another to most effectively and efficiently (i.e. expertly) deliver care to the  most patients? No need for any individual, or even any one group, to answer that question. But essential for the organization to answer it, over and over again. 

How does OD happen?

The scaffolding that will support OD will include components that define and illustrate the organization’s design, leadership, strategy, clinical and business operations, customer service, team development, culture, and more. 

These will include:

Identity

  • Who we are
  • Organizational structure
  • Mission, vision, values
  • Business strategy & finance policy
  • Strategy, re partnership, with the organization’s members & customers

Operational structure and process

Continuous improvement                   

Communication strategy

  • Effective information sharing to engage members and customers and to propel change

Growth strategy

  • Why and how should the organization grow and evolve? For what purpose, and does that purpose belong to the organization’s members or its executives?

The rewards of OD

This scaffolding invites introspection and self assessment, which gets minds thinking and people talking about what to make better and how—change! It lubricates dialogue between the individual and the organization. Change is not only anticipated, it is desired. OD takes reasons to resist and transforms them into change initiatives. A staff becomes a team, and a customer (or patient), becomes a partner.      

RELATED TOPIC: How to obtain operational effectiveness in the health care arena                              

OD, through a systematic reliance on organizational and operational structure and change management processes, influences worker behaviors, focus points, and results. It functions to align the member’s goals and activities with those of the organization so that individual and organizational efforts complement one another. 

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Jun 20, 2021

Medical device companies: how to prepare for Brexit

medicaldevices
supplychain
Brexit
Compliance
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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