When you embark on a building a business or a new venture there are lots of new things to learn. It can be incredibly daunting when you start to realise the sheer volume of things you just don’t know.
For example, if you’re a product person, you may not be comfortable with accounting and business development. If you’re a sales person you may not have a clue how software development, electronics and version control is handled. If you’re a software person, then you may need to deal with customer support, prospects and physical logistics.
Each of these new areas has its own language, including endless acronyms, which are probably annoyingly similar or the same as ones you already know but have completely different meanings in different areas. Be very careful in trying to assume what an acronym means in a new area – be brave and just ask those ‘stupid questions’ so what do you actually mean by ‘SOP’? Don’t ask me how I know this, but you look an even bigger idiot when you use the term incorrectly in front of someone else.
For Playphysio one such area of learning is MDR (that’s Medical Device Regulation, glad you asked?) In some ways MDR and the people that work in this area seem like:
A secret society, a club or an organization whose activities, events, inner functioning, or membership are concealed. The society may or may not attempt to conceal its existence. The term usually excludes covert groups, such as intelligence agencies or guerrilla warfare insurgencies, that hide their activities and memberships but maintain a public presence.https://en.wikipedia.org/wiki/Secret_society
I’m only half joking here! MDR practitioners and software companies tend to hide behind large ring binders filled with ISO standards, regional regulations, interlinked legally required processes, operations and monitoring. In honesty, I feel that we do have to respect these professionals it is a significant area to manage and critical for patient safety. But what is particularly challenging is the tacit secrecy around meeting MDR requirements.
Recently I have found an organisation that ignores the cabal of MDR consulting. If you need MDR in your life/venture/business I’d head over and take a look at Open Regulatory and reach out to Oliver Eidel. Trust me, it might just be the best thing you do today. Open clear and practical advice on how to adhere to MDR for medical startups. As Oliver explains:
OpenRegulatory enables Healthcare startups to solve regulatory problems by providing free templates and a Slack community. With their screencasts, we were able to create most of our documentation ourselves, saving lots of expensive consulting hours.Dr Oliver Eidel, Open Regulatory
The team also provide consulting services if required for more bespoke requirements, so you can cover specifics to your product/service/software.
Disclaimer: Open Regulatory have provided Playphysio with free access to their video content in order to help us keep on top of our MDR requirements. Aside from the quotations noted above, the opinions expressed above are the authors own and don’t imply endorsement from Playphysio CIC. Playphysio also uses and has used other MDR consultants and companies in the past, as paid services, voluntary services and as mentors. We acknowledge and thank you all, you know who you are!