Early this year, I published an article on the challenges and opportunities of working in a startup. In Part 2 to that article, I want to focus attention on the unique challenges of medical device startups. These challenges are both external and internal.
For health technology startups, the external challenges can be particularly daunting: how to keep up with evolving regulations and standards while maintaining traceable documentation. While this sounds straightforward to a regulatory professional, these can be daunting challenges to a startup employee with a hand in every department. Regulatory work may fall into the domain of an R&D engineer. Even for a company with a well-staffed regulatory/quality department, meeting external challenges requires cross-functional support. As the team works hard to push out the next product, documentation can fall by the wayside. In fact, paperwork appears to be an obstacle to be swept under the carpet until it’s way too late. But when is it considered way too late? When it comes time for audits and inspections, it’s the scrambling to complete and collect records. However, these external checks are not frequent occurrences. By the next audit/inspection, at least one year will have passed, and that’s one year’s worth of records unaccounted for if no effort is put into documentation. In addition to procedures, it cannot be stressed further that the effectiveness of a company’s quality management system (QMS) is also determined by the extent and quality of documentation.
Documentation, documentation. Show your work, as a high school math teacher once reprimanded, so I can grade you on your thinking process. Documentation is the QMS equivalent way of showing your work. The initial problem can be a CAPA: showing your work means writing down how you arrive at the root cause and what steps you take to implement your corrective actions. Another problem can be evaluating a complaint for reportability to a regulatory authority. Where is the rationale documented? Records are important because they are evidence of how a company conforms to international standards and complies with regulations. Records are the nitty-gritty of a QMS; they are not fun but they get you the brownie points.
Having strong processes and documentation may help the startup get through the next audit or inspection, but another challenge of working at a startup is internal. It is how to collaborate with colleagues with varying levels of experience and understanding of the QMS. The challenge may be unique to startups. What most people take for granted in a well-established company needs to be learned from the ground up (e.g. how to put together a design history file or writing a risk management plan ). In a high-pressure environment, there is not that much time for learning how to write a design and development plan or an engineering change order. In any other company, these fall within the responsibility of seasoned R&D or process engineers. However, at a startup, other colleagues may have to pitch in, even if they have never written a design and development plan. For some, this collaboration makes sense. After all, in a startup, people pick up whatever tasks they can regardless of their training and experience. Other people, however, prefer defined roles and responsibilities. My own view is somewhere in between. Collaboration is important even if you are not an expert in a particular subject. But everyone will eventually need to develop their own expertise to generate high-caliber documents. A company is not a one-man show. How everyone can get there is not clear. The answer is not clear-cut, but it should be tailored to the particular needs and experience of the company. This may mean sending employees out to workshops and seminars, helping them find the resources to get up to speed.
Where does all this leave regulatory and quality professionals within a medical device startup? In the short term, they can patch up the holes in the QMS through responding to audit findings and making QMS improvements. In the long term, it is the company as a whole that needs to be brought into a culture of quality and compliance. This means strong collaboration between different departments led by regulatory and quality colleagues with a knack for distilling regulatory requirements into layman’s terms. Collaboration means guiding key employees on how to write regulatory documents and identifying training opportunities. As important as getting the next product approval or passing an annual surveillance audit, the long-term challenge is internal and it is much less straightforward. It is a puzzle that will take time and a spectrum of personalities.
ideas and culture 