In the highly competitive world of health care, providing the
latest in diagnostic and therapeutic technology is increasingly expected
by information-savvy health care consumers. Successful health care
organizations are obligated to embrace such technology and enable its
use through availability of highly qualified professionals and effective
While providing such an environment can be difficult to achieve,
the rewards engendered by public recognition, of an organization's
critical differentiators have tremendous potential to impact that
Creative, multipronged approaches to promote and facilitate
innovation are required. Key requirements include an organizational
commitment of appropriate resources to provide critical support, as well
as the means to enable, and incentives to encourage adoption.
Those organizations that have supported such an innovative culture
discover that this environment elicits added benefits, including
enhanced patient safety and satisfaction, more effective communication,
continuous process improvement, and a fully engaged clinical staff
At first glance one might argue a culture of innovation should be
considered the norm for all levels of health care. For example, in one
author's specialty of surgical oncology, less than 50 percent of
the procedures currently performed were learned during residency
Undoubtedly, this would be typical for many health care practices,
implying that a more comprehensive view of clinical innovation is
needed. Perhaps it would be more useful to embrace concepts that
include, but arc not limited to, introducing "new, unique, or
Using an established technology to treat a new disease or in a
different specialty might reasonably be considered innovative. So too
would applying an established practice from another field, even one from
outside clinical medicine.
A useful example is bringing the concept of "consumer
centrism" into health care after it's been a standard practice
for years in the business community.
It is useful to broadly divide health care innovation into process
improvement activities (e.g., Total Quality Management, Lean, Six Sigma,
etc.) versus technologic advances (e.g., device, drug, or procedure).
Some innovations of course, are both process-enhancing and
technical--such as electronic health records.
While it is easier and more familiar to most health care
professionals to consider innovation in the context of a new device or
procedure (e.g., robotic surgery) or a new medication (e.g., targeted
anti-cancer therapies), the entire scope of quality improvement is
deeply rooted in the concept of innovation.
'This can be appreciated when considering The Keystone Project
and a related larger study that addressed the benefits of absolute
attention to meticulous sterile technique during insertion of central
While the concept of sterile technique is certainly not innovative,
unconditional insistence on its application coupled with staff
empowerment to enforce appropriate processes was clearly so.
The resulting decrease in central line infections and the
associated savings in both lives and revenue is testament to the
innovative application of an otherwise straightforward process
Innovative health care organizations are populated with innovative
clinical and administrative staff. Having the right people is critical.
Any health care organization that undertakes the strategic decision to
expand into new programs and endeavors must consider how to enlist or
recruit the talent who will support this decision.
Presuming that an innovation program makes clinical and business
sense, it is appropriate to begin with an evaluation of the capacity for
existing staff to deliver/provide/support the program.
In the case of health care organizations whose revenue is derived
almost completely from patient care, there will be a limited capacity of
existing staff to foster and manage innovation.
In these settings it might be better to adopt technologies
developed and tested externally. Typically, one can identify a
"champion" on the staff, who is motivated toward acquiring the
technology for their practice, and provide to that individual the time
and support for training and testing until an acceptable level of
proficiency is achieved.
This champion can then bring the innovation into the organization
and disseminate knowledge and skill to others who can practice the
innovation for their patients.
But innovation capable of transforming an organization is built
largely around both technology-specific and process-improvement
practices. In the latter, these skills are not acquired as a part of
medical practice training and are frequently not present in clinical
It is our experience that organizations that wish to foster a
culture of innovation need to recruit skilled individuals to bring about
this transformation. Qualified clinical practitioners will come most
often from academia. As for process innovation managers/directors who
are not clinicians, most will come from the private sector or with
formal process improvement training beyond that found in traditional
hospital quality departments.
A core group of staff with the knowhow to implement programs such
as Six Sigma, Lean, and other transformational processes bring an
organization the ability to examine every aspect of its systems,
processes, revenue stream, and outcomes.
The value of this sort of information for health care cannot be
overstated. It is fundamental to all strategic planning and decision
making on behalf of the organization. In the future, it is likely that
the viability of all health care organizations will be based in large
part on their capacity to practice quality improvement innovation.
While innovation leaders were previously found most often in
academic centers, recent experience reveals that academic medical
centers have increasingly been training their own competition.
This situation has enabled a growing number of community health
centers to provide tertiary and even quaternary clinical care resources
and attract increasing numbers of uniquely qualified clinical staff. In
fact, some of the most significant recent innovations in health care
(e.g., minimal access surgery, interventional cardiology etc.) nave
originated from people based primarily in community health care
If recruiting outside clinical staff is necessary to support a new
program, efforts need to be carefully planned. Cursory evidence
supporting an individual's capability may require only brief review
of their curriculum vitae (GV). But a CV can sometimes be misleading.
Particular attention should be paid to aspects of experience that
are highly indicative of an orientation toward clinical innovation
* Area of research interest
* Level of research activity, especially over the long-term
* Grant support
* Peer-reviewed publications
* Service on local, regional and/or national organizations engaged
in clinical innovation and system improvements
Another kind of "right" person for an innovative health
care organization will be support staff required to facilitate and
shepherd innovative activities. This includes people in research and
development and quality improvement offices,
Ideally, there is a cooperative give-and-take relationship between
the research offices and the clinical staff- This greatly facilitates
the ability to identify opportunities and bring them to fruition.
Skills of the ancillary support staff needed to enable clinical
innovation include expertise in all aspects of protocol development,
activation, performance, data collection, monitoring, and reporting of
clinical trials as well as the federal regulations that govern these
activities in patients.
The lack of qualified individuals with knowledge and skills to
oversee and enforce clinical research practices can, and has, threatened
the reputations of some organizations. For this reason, it is
appropriate to have one highly qualified professional with
administrative authority and responsibility for these institutional
functions. This individual and his/her team should be given broad
authority for the organization, staffing, and operations of the clinical
Additional research and development personnel necessary to support
the clinical staff involved in innovation require the existence of a
formal protocol office with research and data coordinators, clinical
protocol nurses, and administrative support.
It is the clinical protocol office that is the institutional
mechanism responsible for guaranteeing that the institution will conduct
its clinical innovation activities according to "Good Clinical
Practice" (GCP) Standards. While full discussion of the elements of
GCP are beyond the scope of this article, they emanate from the U.S.
Code of Federal Regulations (CFR), Title 21 and Title 45 and are
designed specifically to ensure the protection of human subjects who
participate in clinical research.
Institutions that undertake innovation through clinical research
also must have these activities reviewed, approved, and monitored by an
"Institutional Review Board" (IRB). The IRB is charged under
FDA regulations to perform these functions to protect the welfare of
human subjects participating in an institution's clinical research
programs. Significantly, federal regulations mandate that this board be
completely independent of the institution for which it performs these
Departments devoted to quality improvement in truly innovative
organizations avoid the tendency to take technology and embed it in
unchanged care delivery processes. Instead, they connect and rearrange
Process innovation can involve revolutionary or breakthrough
improvement in broad, cross-functional processes or it can entail
continuous or onetime improvement in smaller processes such as those
often connected to TQM or Six Sigma initiatives.
Skills of the ancillary support staff needed to enable clinical
innovation based on focused attention to systems and process improvement
include expertise in all aspects of quality improvement:
* Quality planning and design
* Measurement strategies
* Assessment and current state mapping
* Improvement tools and techniques
* Project management
* Process control
These individuals focus upon process innovation through sequential
testing on both a small- and large-scale basis to determine merits prior
to widespread organizational adoption. They play an essential role in
providing guidance and support to clinical staff who have often not
until recently been adequately exposed to process improvement tools and
techniques applied successfully in industries outside of health care.
These individuals must be equally proficient in coaching and team
building and possess strong communication skills. To be successful,
their work depends on their ability to build on the accumulated
knowledge of the organization and its people in making meaningful change
and advancing innovations.
Encouraging innovative ideas
Physician executives can play an integral role in bringing
innovative ideas to their organization by regularly monitoring the basic
and clinical literature as well as routinely networking with key
professional associations. Moreover, physician executives are often in
the best position to engage their clinical colleagues in innovative
program identification and process improvement.
Merely "bumping into" innovation is far less likely to be
successful than when an active, intentional, and well-delineated
strategy is in place. One component of such strategy involves the
physician executive enlisting the input and support of clinicians not
generally accustomed to practicing innovative thinking.
This can be accomplished by a structured dialogue where the staff
member is asked initially to describe in detail how they do their
particular job and to consider how in the perfect world they might do
that job better.
It is useful to engage in such a discussion in the same venue that
the clinician delivers their care; this not only displays a sincere
interest on the part of the physician executive but increases the ease
with which the clinician can demonstrate the issue at hand. That simple
interaction may be all that is necessary to allow these highly trained
individuals to properly frame their issues. Depending on the
circumstances, the results are often remarkably innovative, challenging
conventional thinking and current delivery processes.
When functioning optimally, an organization's quality and
safety program will go beyond routine monitoring of clinical
practices/programs into in-depth evaluation of those processes from both
a patient's perspective, as well as that of clinical staff
The data provide a wealth of information to justify and guide
"innovative" process improvement. Quite commonly, processes
thought to be optimal have often evolved without solid justification
and, once evaluated, are in fact shown to provide less than ideal care.
The physician executive can strategically use this information to
weave various quality care teams through the fabric of the traditional
medical staff executive committee. A physician executive may assist in
creating the framework in which the "right" group of
individuals can engage in dialogue designed to light the innovative
Brainstorming sessions may be useful opportunities for diverse
clinical specialties to opine on possible organizational innovations.
While formal brainstorming consultants may be used, such sessions are
well within the capabilities of a properly prepared physician executive.
Successful brainstorming sessions require both preparation on the
part of the facilitator and clear delineation of
"rules-of-the-road" to the participants. Such rules include
awareness that no idea is bad and that all (sincere) comments are
This session should allow delineation of the "sandbox"
wherein innovation can occur, followed by identification of specific
opportunities and projects. These sorts of sessions are best performed
off site where participants are free from the distractions of phones and
pagers. It is the facilitator's paramount responsibility to keep
It should be understood by all participants that detailed
descriptions of ideas is not the goal of these sessions. Rather, they
are aimed at defining the "universe of opportunities" for
innovation within a division, a department, or an entire organization,
identifying specific projects, and enlisting the appropriate team to
bring them to fruition.
By the session's end, specific projects will be identified and
prioritization should be given to different ideas, often through
affinity voting or some other quantitative tool. Appropriate
stakeholders should be determined who are charged with creating the
development plan with appropriate milestones, timelines, metrics and
budgets. Here is the time for more detailed description and
Another useful activity to help drive innovation, but which has
lost some of its luster in recent years, is the classic grand rounds
meeting. In these conferences clinical cases are presented to the
diverse members of the clinical staff and are discussed in some detail.
While tumor boards and other specialty specific conferences have
proliferated, the broader audience, characteristic of grand rounds type
presentations is less common.
The physician executive should organize grand rounds and might
choose to moderate such conferences, since in addition to facilitating
innovative thought, they are also useful opportunities to engender
organizational camaraderie and communication. These have the added
benefit of providing continuing medical education (CME) credits.
Innovation "summits" are another venue to more thoroughly
vet ideas in a broader context to both clinical and administrative
audiences. Generally, such summits involve didactic presentation of
varying "in practice" or proposed innovative clinical programs
or processes with some opportunity for discussion.
Innovation summits provide an opportunity to review progress,
consider modification or expansion, and clarify future plans. In
addition to a focused analysis of a clinical innovation, summits may
stimulate a related idea in other individuals and disciplines.
Unfortunately, the expanding time constraints on the busy clinician
today are such that doctors have little time to monitor the literature
and/or network with their particular professional association/societies.
Innovative health care organizations recognize this and not only
encourage such activity out facilitate it. This generally requires ready
access to the professional literature either through a well stocked
hard-copy and electronic medical library or, less likely adequate
institutional support for staff subscriptions to the top tier journals.
Innovative institutions also recognize the value of providing
financial assistance for key staff to attend national meetings for
presentations of cutting-edge clinical and scientific information.
Beyond fostering an innovative orientation for attendees, these meetings
support staff licensure and related CME requirements and provide a
positive inducement in clinical contracts.
It is necessary to monitor this process; this does need to be
tracked to ensure time is well spent and not merely paid vacation time.
One useful way to minimize such misuse is by tying support to a required
clinical presentation of the events activities subsequent to the
clinicians return. This has the added benefit of providing CME for the
rest of the staff as well.
Clearly, for busy clinical staff to succeed in conceiving, creating
and delivering innovative programs, more than merely bringing the right
people together and fostering dialogue is required. This is particularly
true if those same clinicians do not see ready evidence of now such
innovation can be realized and how it will improve their or their
In other words, getting them involved requires somehow vesting them
in the whole innovative process. There are numerous means to encourage
this, ranging from creating formal salaried positions (i.e., medical
directors) and incentive-based compensation to non-financial means such
providing resources, continuing educational support, and other
Interestingly, these non-monetary motivators are often highly
attractive to even the most jaded clinical staff members if they have an
interest and passion for learning about and creating the means to
improve the human condition.
Implementing innovative ideas
Innovative ideas should be assessed for their value from both the
clinical and the business perspective. While clinicians are essential to
building the clinical case for most kinds of health care innovation, the
decision to move forward requires the input of administrative staff who
understand the financial ramifications of adapting that innovation.
The decision-making process must provide sufficient analysis, based
on all aspects pertinent to the revenue systems of the institution, to
justify the business case for the innovation. This dual approach to
evaluation is critical to guard against the adoption of non-sustainable
innovative processes, no matter how attractive to the clinical staff and
how appealing they may appear to administrative staff.
Assuming an innovative idea makes both clinical and business sense,
most clinicians don't have the training, experience, or time to
bring an innovative idea to fruition. So it is imperative that the
physician executive foster an environment that is both conducive to
innovation and its implementation. These opportunities require the
ability to understand all aspects of the clinical application(s) of the
innovation, and the ability to manage highly complex challenges to its
implementation. Such innovation is generally categorized as:
1 Proven but new to the organization and/or individual practitioner
2 Relatively proven (e.g., moderate support in the literature) and
new to the organization and/or individual practitioner
3 Unproven and new to the organization and/or individual
For #1, the task of introducing the innovation is somewhat less
onerous but necessitates appropriate attention to credentialing
requirements and monitoring of outcomes; outside standards for such
outcomes may already be established and can be adapted to the
Innovation identification and adoption of this level was
demonstrated recently when laparoscopic cholecystectomy and subsequently
minimal access surgery was rapidly introduced to medical care.
For #2, the same credentialing mechanism applies but this level of
innovation also necessitates a determination by the organization as to
whether a standard IRB protocol is required. This will of course depend
on a number of factors, including the level evidence in support of the
Finally, for #3 careful attention to universal standards of
clinical investigation following all human rights protection rules is
essential. Until recently, this level of research innovation was limited
almost exclusively to the academic environment; this paradigm too has
undergone substantial evolution. Based on the number and complexity of
patients currently treated in community health care organizations, this
pattern is likely to expand.
Contractual consideration of clinical staff remains an important
component in facilitating innovation implementation. While academic
health care institutions have more experience with this concept, even
these organizations are "all over the map" on how they deal
with this area of innovative support. Issues to consider include
financial arrangements to the level of partnerships and intellectual
property protection, personnel, laboratory support, and others.
The degree to which such inducements are provided is an important
strategic decision but well worth the time and effort. Proper attention
to delivering this relationship can be used to encourage rather than
restrict such activity.
It is important for an institution to have or create policies that
govern ownership of intellectual property and the distribution of any
proceeds that may emanate from same. The best policies balance the
rights of the institution with the rights of staff members responsible
for producing ideas (inventions) that can be reduced to clinical
The best example of this is in innovation that rises to the level
of an invention suitable for protection by a patent, trademark, or
brand. Significantly, protection of an invention is not restricted to
new products or devices; in these cases, the potential upside for both
the institution and the staff member can be considerable and mandates
that policies be designed to share the benefits derived from the
innovation. Good policies can be highly motivating to staff with the
inclination toward clinical innovation; bad or unequal policies will
Unfortunately, institutional policies in this area are also all
over the map. This is especially problematic for institutions that have
not traditionally engaged in the sort of innovation capable of producing
new ideas, products, devices and processes.
The strategic decision to foster a culture of innovation in any
clinical institution should recognize the possibility that the fruits of
that enterprise will produce discoveries sufficiently unique, attractive
and capable of being practiced to warrant a level of protection afforded
to intellectual property. Equitable policies provide substantial
motivation to engaged staff as well as serve to attract new talent into
an organization that practices innovation under these policies.
An innovation implementation plan should include all elements
related to goals, timelines, staffing, budgets, and strategies for
continuous monitoring and improvement. But beyond these essentials, it
is valuable for the plan to include a communication and education
With rare exception, clinical innovation will require communication
to a broader audience that includes physicians (colleagues, referring),
support staff(nursing, administration), department heads, board members,
the public, and others. This process will have begun by targeting a more
limited group as a natural consequence of building the clinical and
But once the plan is activated, communication devoted to the
innovation must be of adequate scope and schedule to thoroughly involve
the broader target audience whose participation and support will
ultimately determine the success of the innovation.
Successful implementation of new innovation necessitates a
comprehensive training/education strategy as well. For example, support
staff must be adequately trained and sufficiently comfortable with all
aspects of a new diagnostic or therapeutic innovation prior to bringing
this to the patient's bedside.
Equally, support staff must be adequately consulted and trained on
any clinical process innovations likely to redirect their routine
practices in care and delivery. Only through a comprehensive, structured
education program is this likely to occur.
Finally, successful implementation also depends on monitoring
adoption and utilization of the innovation and its effect on the outcome
targeted for its use. A particularly effective way of assessing the
value of any innovation is to know the baseline data prior to
introduction of the innovation and to continuously monitor its impact in
a prospective fashion by regularly analyzing predetermined outcomes,
process, and structure measures in real time.
Using such an approach will optimize all aspects of patient care
affected by the innovation, as well as ensure consistent performance,
staff acceptance and continuous process improvement.
Advantages of Clinical Staff Innovation
* Improved quality outcomes, processes and structure
* Enhanced patient safety and loyalty
* Creation of critical differentiators
* New revenue streams
* Enhanced organizational reputation
* Enhanced fund-raising/philanthropy
* Significant key to enabling institutional strategy for growth
* Enhanced relationships with key constituents (pharmaceuticals;
specialty interest patient groups; other organization/association
* Requirements for Clinical Staff Innovation
* Motivated core clinical and support staff
* Additional staff - Professional
* Additional staff - Support
* Additional infrastructure (e.g. Protocol office; Institutional
Review Board, certified process improvement specialists)
* Rigorous adherence to multiple federal and state regulations not
inherently familiar to clinical staff
* Skill development and training on robust improvement techniques
* Collaboration between clinical and admistrative staff
Mechanisms by which Physician Executives Can Encourage Innovation
* Develop/implement an innovation strategy
* Network with diverse clinical staff
* Facilitate the clinical staffs access to innovative information
* Enhance organizational continuous quality improvement process
* Regularly engage clinical .staff in structured dialogue (in
practice care setting)
* Perform "brainstorming" sessions
* Organize regular "grand" rounds conferences
* Organize innovation "summits"
Issues o Consider Regarding Clinical Staff Innovation
* Does the innovation make clinical and business sense?
* Not efficient if practiced sporadically
Not efficient if the organization attempts to engage all staff
regardless of interest and/or capabilities
* Need, for specialized training and credentialing (e.g., Human
Need for uniquely Qualified "support" personnel
* Need for substantially increased capacity for data collection and
(1.) Pronovost F and others. An intervention to decrease
catheter-related bloodstream infections in the ICU. N Engl J Med,
By Edgar D. Staren, MD, PhD, MBA, Donald P. Braun, PhD, and Diane
S. Denny, MHA, FACHE
Edgar D. Staren MD, PhD. MBA is senior vice president for clinical
affairs and chief medical officer at Cancer Treatment Centers of
America. Zion, IL
Donald P. Braun PhD is vice president for clinical research at
Cancer Treatment Centers of America. Zion, IL
Diane S. Denny MAH, FACHE Is vice president for quality, patient
safety, and clinical innovation at Cancer Treatment Centers of America.