MedTech Innovation using a structured Biodesign process: Barriers and Opportunities

INTRODUCTION

Approximately 75% of all the medical equipment and diagnostic devices that are being used in India are imported from many of the developed countries, which makes healthcare costly. This has proven to be a bottleneck as witnessed in the current COVID crisis as well when there was a sudden increase in the need of many such devices to be deployed across the healthcare delivery ecosystem at a rapid pace. Furthermore, many a times, they are not adapted to the needs of India’s unique healthcare ecosystem which include the healthcare provider’s approach to care, variable sourcing needs, and who exactly reimburses the cost of healthcare delivery. Hence, currently, there is a dire need to indigenously develop medical technologies to fulfill the specific needs of our unique Indian healthcare ecosystem. Few current relevant examples are the oxygen generating plants, oxygen concentrators, ventilators, etc.

The Stanford biodesign process

The implementation of the biodesign process started from the Stanford Biodesign program^[2,4] of the well-known Stanford University through Stanford Byers Center for biodesign which began in 2001 with a primary focus to train leaders in Biomedical Innovation. The differentiating feature of this process is the priority on needs identification through clinical observations, a formal selection process, researching and characterizing needs through structured filtering process before beginning the process of inventing. The teams involved typically spend 3–5 months performing need identification and characterization before they even start thinking of a solution. The Stanford Biodesign process has 3 phases with 6 stages with various activities happening in each stage [Figure 1].

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Figure 1:

An infographic of the three phases of biodesign process is shown here as elaborated by Stanford biodesign.

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Phase of Identification

This is the phase where the unmet needs are first identified that are later clinically validated. A multidisciplinary team composed of an engineer, a product designer, a business graduate, and interestingly, a doctor who is a critical part of such teams, carryout clinical observations inside a hospital at bedside, in a specific focus area or a problematic domain of hospital such as OPD, procedure room, and laboratory for a period of 6–8 weeks. The team shadows/follows doctors, paramedical staff, and patients during this period, and keenly observes the activities between health-care personnel and patients including interactions, procedures, and the overall care provided. This is termed as clinical immersion. The team is informed to note down all the observations including seemingly efficient processes and also inefficient practices and poor health outcomes without any bias. After systematically documenting the observations for around 6–8 weeks, the team brainstorms to categorize and sort the observations using a defined process to filter out the not so relevant ones.

Once a critical need is identified, a structured document containing a set of all the needs criteria is compiled. This so-called “needs criteria” essentially is a list of must-haves and nice-to-haves in the proposed solution, which actually are the objective parameters that are expected to be satisfied from the prospective solution.

Phase of Invention

During this phase of invention, the team brainstorm all possible ways in which the need/problem can be addressed/ solved. This brainstorming session focusses on generating a large set of ideas that build cumulatively on each other. The problem statements to work on are selected based on satisfying these needs criteria initially outlined in the need specification document. In the next phase, the teams focus on the constant prototyping and validation with stakeholders.

Phase of Implementation

This stage includes evaluation of the intellectual property issues, regulatory compliances, validating the stakeholders, and strategy to adopt in marketing and also includes the plan for manufacturing process, operations, and finance. The preclinical and clinical testing of the prototype is also taken into account.

As an example of the practical application of Stanford Biodesign program in cardiology was, solving the unmet clinical need of the “detection of potential arrhythmias in non-hospitalized patients.” With a team led by cardiologist as part of the biodesign program, the top solution that filtered out was a long term (up to 14 days), water resistant, disposable patch-based monitor to identify cardiac arrhythmias. This cardiologist eventually formed a start-up and licensed the technology from Stanford, following which their team developed a complete solution, which included a cloud-based algorithm and robust supporting services. The device is currently commercially available [Figure 2]. To date, the device has been used on nearly 500,000 patients, and several publications have documented the clinical and economic utility of the approach. This device is an example of a successful medical device initially conceived by a fellowship group in the Stanford Biodesign Program. It is currently commercially available in the United States and Europe.^[5]

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Figure 2:

A novel single-use, 14-day cardiac event monitor.

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MATERIALS AND METHODS

A well-designed and structured process was used to chalk out unmet clinical needs, wherein multidisciplinary teams went through clinical immersions, figured out various crucial needs, validated their understanding with subject experts, brainstormed about the new strategies/solutions/approaches, and then did the prototyping of these solutions, as shown in [Figure 3]. In the first stage, a multidisciplinary team carried out simple clinical observations at bedside in a specific focus area of hospital. The team followed doctors, paramedical staff, and patients as well and keenly observed the care provided, in an unbiased manner. The team was instructed to note all observations including the inefficient practices and poor health outcomes. Then, the members of the team understood the critical and exact needs after performing deep dive into the keen observations made their indications and implications. Following this step, based on various factors such as clinical implication of the need and its criticality, frequency of the negative outcomes, and the market potential of the proposed solution, the team filtered out the various needs collected in the previous step. Once the critical need was figured out, the team then brainstormed various possible methods in which the problem could be solved without any bias. The intention of these brainstorming sessions was to generate as many number of high-quality ideas and solutions as possible to solve the critical problem. Finally, the team prototyped the most relevant solutions and validated their work with clinicians. A start-up was planned after this stage if the critical need and the suggested solution seemed to be sustainable in all ways at this point as well so that the solution is brought to the market and scaled up.

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Figure 3:

A well-defined and structured process in MedTech innovation.

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RESULTS

Outcome of 2 months of clinical immersion

Outcome was quite interesting, with 71 detailed observations made overall. From this set of observations, 52 critical and unmet clinical problem statements with significant negative impact on patient outcome were obtained. The members of the team then worked up to identify the fundamentals of the disease state involved for better understanding, current treatment and management options, challenges with the current management, potential market size, business competitors in the market, regulatory clearances and requirements needed, and business models that would sustain and reimbursement methods. All the teams then worked on the need/problem statements that were documented during the initial phase of clinical immersion. This was done by applying four rounds of appropriate filters after discussion with treating pediatricians and the administration of the hospital, including the parents as well who are also the important stakeholders in the ecosystem, as shown in [Figure 4].

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Figure 4:

A graphical representation of the key steps in the filtering process.

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Strong motivation and personal interest are also key roles in determining the critical needs which would be pursued further, as shown in [Figure 5].

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Figure 5:

Some of the critical needs that were identified following a structured biodesign innovation process.

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DISCUSSION

This article is all about various unmet clinical needs of our unique Indian healthcare ecosystem and the ways to solve them using a well-defined and structured biodesign process. The main advantage and strength of this method were the right identification of multiple critical needs using the clinical immersion process in the shortest possible time period.

The principal barrier while using this method was the absence of a dedicated physician as part of the team which led to a number of challenges later in the process. This caused suboptimal understanding, misunderstanding, and misinterpretation of the core clinical and medical concepts such as pathophysiology of the disease and their fundamentals at a very crucial stage. A dedicated clinician as part of the team serves as a domain-specific knowledge expert during clinical immersions, helping non-clinical members to understand simple medical terminologies, relevant basic anatomy, and pathophysiological processes of the disease. He can also help during brainstorming and guide the team in selecting the appropriate possible solutions. We were forced to spend extra amount of time for extensive research and understanding by talking to various external clinicians in addition to the time spent in clinical immersion due to lack of dedicated clinician in the team.

The next challenge was an inherent sceptical attitude in the health-care ecosystem about the non-medical team members such as the engineers and salesman of the team. Many of the doctors and nurses that we met in hospitals as part of the clinical immersion became very conscious of our presence and were worried that our team was assessing their performance and monitoring their activities to report the negative aspects to the management. A dedicated clinician in the team can always build the rapport with the doctors and nurses and explain the intentions behind our keen observations and break the ice. Finally, without a dedicated clinician, it was very cumbersome to make sense of the observations and also to understand which procedures are the most critical without frequently asking the clinician in the hospital which was not preferable most of the times.

This crucial study activity depicts the importance of a pre-planned, well-structured multidisciplinary team for more effective clinical immersions with a motivated physician as an integral part of the team, bridging the gap, and guiding the team in right path. This whole activity is augmented by the presence of biomedical engineers, designers, and people unrelated to the medical systems in the team, who can look at the scenario with an unbiased and fresh perspective for better understanding and better solutions.

This might not be possible with the doctors alone, as they might get adapted and biased due to constantly working in the same setting for a long time and unfamiliar with the available technologies and systems to solve these problems. This is very crucial for the success of the end product which might be a medical device or a service that needs to fit seamlessly into the existing clinical workflow of clinicians or paramedical staff.

Spending many hours inside a hospital at bedside observing the doctors, nursing staff, and patients give a better understanding to the engineers, designers about various practical aspects of design, size, and orientation for the devices they would be designing. Ex: Nurse might have only one hand freely available while performing a specific procedure when handling children, or devices aimed toward children require specific considerations in size, positioning in ICU, bedside, etc. When the whole team is together in the clinical space, it allows more opportunities for each team member to better understand the user who might be a nurse, doctor, administrator, or the patient himself. Our experiences say that these deeper understandings and clinical insights can definitely motivate the various team members to continue to develop products and services in scenarios where others would have easily considered as not feasible. Thomas Fogarty, an internationally recognized surgeon, inventor, and entrepreneur noted, “Innovators tend to go out and ask doctors what they want rather than observe what they need. When you talk to physicians, as well as others involved in the delivery of care, you need to learn the difference between what they say and what they want, and what they would be willing to pay for, and what they actually do.”

MedTech innovation is a well-structured process that requires multidisciplinary team with collaboration across various domains. For this process to be successful, it requires complete commitment, dedication, and coordination among all team members. After initial challenges during our immersion stage, we spent couple of weeks getting to know more about the clinicians in the hospital and the department we were observing in, and attempted to recruit them to join our team for better understanding and coordination. The process went on smoothly once we had developed a good rapport with the doctors and nurses. Fortunately, we were able to course correct during mid-immersion, but we highly recommend each team to start the immersion with a multidisciplinary team, complete with dedicated clinicians, engineers, designers, etc., to effectively utilize the advantage of creative collaboration.

CONCLUSION

1. This structured biodesign process when employed to develop a new medical device or define a new process is highly effective in defining and innovate in the strategic clinical focus area which is essential to figure out the right problem for the appropriate solution.

2. Limited involvement by the clinicians in initial stages and the sceptical attitude of the doctors and nurses in hospital about the engineers were some practical challenges in the process. This proves the crucial and irreplaceable role of the clinicians not only at the very important stage of the needs assessment but also at every stage of the biodesign process.

3. The clinician has a new role that has emerged out of the biodesign process and all these can be managed by continuing in the clinical domain and at the same time being part of a multidisciplinary team to innovate that saves lives too.