May 17, 2020

Is This the Best Alternative to Health Care M&A?

4 min
One of the main justifications for clinical affiliation is the greater integration between the physicians and the teams that care for patients.
Most analysts agree that this year will be full of health care acquisitions. In fact, when looking to 2015, Tom Baldosaro, CFO at South Jersey Healthcar...

Most analysts agree that this year will be full of health care acquisitions. In fact, when looking to 2015, Tom Baldosaro, CFO at South Jersey Healthcare Regional Medical Center in Vineland, New Jersey, believes the following: “Big is going to be better. Small is not going to survive.”

That’s certainly the case so far as there have been a record number of health care mergers and acquisitions of all sorts in the industry, and one of the main justifications for this influx is the greater integration between the physicians and the teams that care for patients.

But while M&A in the health care space may improve the efficiency of shared services such as human resources and finances, they may actually make it more difficult to improve the coordination of care.

According to Harvard Business Review, “the challenges of combining and managing the resources and operations of the different organizations and aligning their cultures may actually make the goal of integrated, patient-centered care much harder to achieve.”

So what’s the alternative?

In short, high-quality clinical affiliations where providers share best practices and easily consult with each other about patients even if they are independent.

The Mayo Clinic is one source that believes remaining independent and forging a clinical affiliation is a powerful alternative means for integrating care. They further believe it complements local expertise and helps ensure that a particular service is delivered at the place where its value is highest.

The Mayo Clinic elected to adopt this mindset back in 2011 and chose to support independent medical centers by creating the Mayo Clinic Care Network.

“We offer scalable and comprehensive services that help providers keep more care local, making it less fragmented and less costly for patients. In addition, this approach helps to stem the migration of patients to other providers,” the clinic stated.

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To date, clinical collaboration is provided by the Mayo Clinic via three particular information-sharing technologies.

eConsults to allow network physicians to connect electronically with Mayo specialists and subspecialists when they want additional input regarding a patient’s care. This formally documented consultation allows the network physician to bring that additional expertise to the patient within the current care continuum.

AskMayoExpert to provide point-of-care medical information compiled by Mayo physicians on disease management, care guidelines, treatment recommendations, and reference materials for a wide variety of medical conditions. The web-based information system can deliver Mayo’s clinical knowledge to desktop computers or mobile devices.

eTumor Board Conferences to allow physicians to connect via live videoconferences to present and discuss management of complex cancer cases with a Mayo Clinic multidisciplinary panel and other members of the network.

Members also have access to additional services through the network, including business and operational consulting and an extensive library of patient education materials developed by Mayo Clinic. Archived Grand Rounds allow network providers to view presentations by Mayo Clinic physicians and scientists from various internal medical conferences.

To be admitted to the Mayo Clinic Care Network, prospective members must be quality organizations that have a patient-centered culture, a desire to remain independent, and an interest in establishing a clinical collaboration. They go through rigorous due diligence — a formal, detailed review that includes a thorough assessment of the organization’s governance structure, clinical practice (including patient safety), quality and service, as well as an evaluation of business practices such as legal, compliance, finance, human resources and information technology.

“Some network members have described this evaluation process as similar to the accreditation process of Joint Commission on the Accreditation of Healthcare Organizations,” wrote David Hayes, medical director of the Mayo Clinic Care Network, in a recent post. “At first, we believed members would be located near Mayo’s campuses in Minnesota, Arizona and Florida. But we quickly discovered that there was an appetite for this type of collaboration across the country. The network currently has 31 members located across 18 U.S. states as well as Puerto Rico and Mexico.”

To date, physician collaboration through the network is proving beneficial both to Mayo Clinic and network members. Network physicians are able to keep more care of their patients local while providing them additional peace of mind, and it has helped stem the migration of their patients to other providers for second opinions.

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“The collaboration helps keep Mayo Clinic’s expertise relevant and allows it to be an option for patients needing specialty care not available in their communities,” added Hayes. “We also see the network as a source of revenues — both from the subscriptions paid by members and the patients they refer to us.”

In 2014, network members have submitted nearly 2,000 eConsults, and the volume is rapidly increasing. Each request represents a physician who believes that collaboration will best serve the patient. Of these eConsults, less than 15% of those patients were referred to Mayo Clinic for additional assessment or specialty care. The remainder — the vast majority — have been able to receive high-quality, cost-effective care close to home.

“Academic medical centers like Mayo Clinic can and should foster a collaborative environment that promotes integrated, patient-focused care,” concluded Hayes. “When care givers can address the needs of the patient and provide the right care at the right place and the right time, everyone benefits.”


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Jun 19, 2021

Driving sustainability in medical device production

George I’ons
5 min
George I’ons, Head of Product Strategy and Insights at Owen Mumford Pharmaceutical Services on how technology is driving sustainability 

Environmental protection and stewardship are rapidly rising to the top of the corporate agenda and medical device businesses are no exception. The healthcare sectors of the United States, Australia, Canada, and England combined emit an estimated 748 million metric tons of greenhouse gases each year, an output greater than the carbon emissions of all but six nations worldwide. In order to curb this situation various European standards have been introduced. 

The Waste Electrical and Electronic Equipment (WEEE); Restriction on Hazardous Substances (RoHS); Registration, Evaluation, and Authorisation of Chemicals (REACH) and the Energy Using Products (EuP) regulations have all significantly altered manufacturing processes, specific labelling, compliance with disposal restrictions, and creation of instructions for end-of-life management and recycling.

At the moment many medical devices are currently exempt from these regulations but several directives, including RoHS and WEEE, are in the process of being reviewed and could be applicable in future. This is especially relevant for devices that are ‘connected’ and have a digital monitoring component which then brings them under the regulatory purview of authorities that govern devices with electronic components.

Safety, Usability and Sustainability

While medical device manufacturers have been working to respond to increasing demand for environmental sustainability from the market, they also have to contend with a key element of their mission: to ensure safety and usability to healthcare workers and patients. Parenteral and other invasive devices are strictly regulated to help reduce the risk of Healthcare Acquired Infection which typically runs as high as 5% and 8% in most developed countries, according to the European Centre for Disease Prevention and Control. As a result, they typically contain disposable single-use plastic elements.

At the same time, many hospitals and purchasing organisations have started to recognise that sustainable purchasing practices play a pivotal role in reducing costs over time. Many GPOs have appointed and empowered Senior Directors of Environmentally Preferred Sourcing who are successfully implementing the sustainable purchasing business case. In addition global pharmaceutical companies are increasingly creating senior positions with sustainability objectives as key to the role.

Medical device disposal is a particularly burning issue; generally carried out through incineration in the EU, it typically releases nitrous oxide, as well as known carcinogens including polychlorinated biphenyls, furans and dioxins. Some of the strategies trialled by manufacturers to reduce waste matter destined to incineration include sterilisation and reprocessing.

Sterilisation, however, falls short on the environmental front, and may consume more energy and produce more emissions than incineration itself. In the United States for example, 50% of all sterile medical devices are sterilised with ethylene oxide but since this method releases harmful emissions, the US Food and Drug Administration is now encouraging the development of new methods or technologies. Many other established sterilisation methods use glutaraldehyde that is not only harmful to the environment but also tends to be regulated by strict usage and disposal rules such as COSSH guidelines.

Focus on Recycling

The outlook on recycling is changing significantly thanks to new research and technologies enabling, for example, monomer extraction. Recycled polymers can be broken down to their constituent monomers promoting an almost limitless recyclability of some polymers. In addition to this, Polyvinyl chloride (PVC), renewable polyethylene and polyethylene terephthalate (PET) can be recycled several times without losing critical properties.

Reducing the impact of packaging can also significantly reduce the materials that need to be dealt with through either waste or recycling. Packaging manufacturers are decreasing packaging volume by favouring sealed trays instead of pouches, laser-etching instructions directly on to the tray where regulation permits it, or reducing the number of components required overall. In addition to this, for recycling plans to be successful it important to have a full understanding of the practices surrounding device use and to establish, where possible,  closed loop recycling systems that recover the waste materials from hospitals or patients and bring them back into the recycling process.

Sustainable Manufacturing: Technology and Research

Greater employment of fast degrading plastics or material from other sources is a key strategy to reduce harmful pollutants both at production and disposal stage. Bio-based materials can in fact offset the carbon emitted during processing as the monomer source grows, and a growing range of sources for bio based monomers -such as wood pulp or sugar cane- is available. However, when assessing the most suitable material for a part, the entire lifecycle of the product needs to be considered. For example: bio-degradable polymers can contaminate a recycling stream and emit methane when incinerated.

The use of environmentally friendly materials should also be supported by an increase in clean renewable energy sources. Lower energy consumption means fewer carbon emissions but also financial savings, making this an appealing measure for manufacturers. New technologies are proving a major gamechanger on this front, helping manufacturers marry their environmental stewardship with cost savings and efficiency.  3D printing, for example, can help develop optimum product moulds more quickly, refining production parameters to minimise raw materials volumes and maximising output productivity.

Similarly, ‘digital twin’ production software uses inline sensors to create a virtual, real-time mirror of the production environment to enable inline refinements. The objective is to achieve “zero defect”, waste-free manufacturing. In addition to this, LEAN manufacturing methodologies are already helping to optimise inventory management and reduce overproduction. 

Sustainability by Design

It is increasingly clear that effective environmental sustainability in the medical device sector cannot exist without a full view of the product life cycle from concept development, material selection, design and engineering to manufacturing, packaging, transportation, sales, use, and end-of-life disposal. These evaluations are typically made for factors such as manufacturing efficiency, time to market, or safety and regulatory compliance, packaging and transportation costs, but should be extended to energy efficiency and environmental impact by means such as life cycle analysis.  

In addition to this, with devices rapidly becoming more digitally connected, developers need to be aware that the costs of disposable electronics would simply not be viable, or indeed acceptable in the light of electronics disposal regulations. Design therefore should focus on creating a simple, repeatable interface between the two component sections so as not to impair the functionality or efficacy. As reducing waste and harmful emissions continues to exert businesses and governments globally, the medical devices industry cannot stand by. The environmental but also commercial implications of inaction are too serious and the array of solutions now available is exciting and diverse.

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