Medical device projects and life cycles follow the same general format from conception through development and sales. As anyone who has worked on medical device projects can attest, most device-related projects fail. The process of device development can get stuck at any point for seemingly different reasons depending on the life cycle stage, but in reality addressing each of these varying difficulties begins with a common thread: becoming aware of the natural styles and needs of fellow team members.
The most crucial skills needed to function as a team member working on medical device projects are not taught at university. Few courses exist in Design Controls and Manufacturing Process Validation, for example, but websites like medicaldevicecourses.com and certificate programs on Biomedical Device Development like the one at theNew Jersey Institute of Technology do their best to fill in these gaps. In reality, most device professionals learn everything through trial and error while on the job. Employees that see the process take place once or twice with hands on experience generally get the equivalent of a basic crash course, and sometimes more. However, beyond that, further training is still needed to increase productivity and project success rates.
Having a basic idea of the flow and process of medical device development still leaves professionals with more questions:
· How can a team effectively communicate realistic deadlines?
· How can effective cross-functional / inter-departmental communication take place?
· How does a person go about managing unrealistic expectations?
· How can leaders manage and uphold accountability?
· What tactics can prevent scope creep from late or poorly defined Design Inputs?
· What are the best ways to get timely signoff on Design Controls documents?
· How can a device project team operate more efficiently?
Wherever a team member’s expertise lies along the cycle of device development, the success and failure of an endeavor comes down in large part to how different personal behavior styles interact. The best approach is to synthesize the most effective methods out there into a relatable set of steps that apply to the typical problems encountered at each stage during medical device projects. This requires training people how to approach a process (medical device development) using a model and a method.
Laying out the process of device development allows insight into some common challenges for each stage. A few examples that many are familiar with are given in the table below, which is far from all-inclusive.
The challenges in the table above have two common elements:
1. They cannot be solved through superior knowledge of device development or technical expertise.
2. Superior experience can help but is unlikely to fully mitigate them.
The DISC Model
The model used to meet these needs comes from the DISC system of behavioral styles which is then applied to teach people how to tackle the device life cycle. DISC is a validated behavioral style model with a long history of application in a business setting(1–5). In addition to the standard DISC principles which designate four primary styles along with combinations, modern adjustments to the presentation methodology are incorporated to increase retention by trainees. This is the first time this format of the model has been adapted specifically for medical device companies and their unique unmet needs.
Birds image adapted from Rosenberg & Silvert(6)
Birds are used as a mnemonic device in place of hard-to-remember terms to describe the major behavioral styles in the DISC system. When participants understand their own behavioral styles which are determined through a pre-course survey, they are then instructed on the differences between them and how to relate to each one. No one style is superior or more beneficial, but styles can be over or under-utilized as well as imposed on fellow coworkers and direct reports. The nature of how this creates difficulties elucidates the pathway to better communication and avoidance of some unnecessary interpersonal conflict.
While the DISC Model is extremely enriching for its insights into human behavior and understanding the actions of coworkers, managers, and stakeholders, it does not describe a direct method for use in the workplace. For this, a method of application incorporating DISC is necessary. The method, in conjunction with insights from DISC, allows the team to address the process of medical device development and its associated challenges.
The FAST Method
The FAST method is an easily remembered application of the DISC Model which has been synthesized from the best practices in consultative selling, principled negotiation skillsets, and conflict management. Like the modification to the DISC Model which uses a mnemonic device to make it more accessible, the FAST method streamlines several methods and combines them into something applicable to medical device projects and associated challenges. Teaching this method to the trainees completes their toolbox of model, method, and process and better prepares them to deal with their daily challenges “FASTer”.
FAST uses four steps to approach a challenge which involves personality and style differences on a project team.
The stunning simplicity of the steps hides their deep layers of technique and applicative learning. DISC Model training covers the first step sufficiently. What is not evident is tackling the other steps. “Asking” constitutes the art of uncovering needs via candid connection, concern, and a forthright interview process taught as part of the method. Showing and demonstrating ideas as a next step in the method is also not an innate behavior if done as an honest extension of FAST. It requires principled negotiation and empathy, always with behavioral style in mind. Taking action too can be a more complex process than thought, because as any medical device professional would know, it requires verification and/or validation. Overall, the application of the method takes practice and experience to become better at it, but it can yield preliminary results quite quickly.
1. Prochaska, F., Sampayo, J. & Carter, B. DISC Factors. (Social Science Research Network, 2015).
2. Price, L. DISC Instrument Validation Study. People Keys
3. Suman, E. Role of behavioral and personality instruments in the improvement of team effectiveness in the organization. Perspect. Innov. Econ. Bus. 3, 80–83 (2009).
4. Reynierse, J. H., Ackerman, D., Fink, A. A. & Harker, J. B. The Effects of Personality and Management Role on Perceived Values in Business Settings. Int. J. Value-Based Manag. 13, 1–13
5. Jeffrey Sugerman. Using the DiSC® model to improve communication effectiveness. Ind. Commer. Train. 41,151–154 (2009).
6. Rosenberg, M. & Silvert, D. Taking Flight!: Master the DISC Styles to Transform Your Career, Your Relationships…Your Life, Student Edition. (FT Press, 2012).