Product development can be a mess especially in medical devices. Let me walk through some observations that might resonate with you and maybe give you sense of what I see are countermeasure to protect your time and money.
There are so many things to consider when thinking about new product development. Is the idea good one? will somebody want it.? I really don’t want to talk about that because once you are convinced you have a good idea you often have faith that you just need to put the product out there. Let’s assume you have the right product and now you just want to execute the design. It should be easy right? You are a start up; you have raised some money and now you need to just do it. You hire some people to help you, and you are off to the races.
Here are some challenges you might face; think about if you have had any these come up in your past.
The team you hired has different opinions about the level of documentation and approaches to various documents like the product requirements, and how to perform: risk management, verification, validation, and regulatory submission. The QA person you hired does not have enough experience to navigate the grey areas of the QSR on design control and asks for more a more, nit picking on wording in documents to achieve perfection, the designers sometimes gristle at the constraints of documentation. The resulting delays and redoes in documentation result in wasted time; you are walking or crawling when you should be running. They are afraid of agile development and insist on waterfall development in a design approach. I have seen a company get run into the ground by an indecisive quality team that slowed rapidly needed changes to a crawl with undue process and it resulted in the company running out of cash.
Your design team knows they need to design to the IEC 60601 or IEC 61010 standards, but once they get into testing they missed something and have to go back and perform a redesign; they misinterpreted or missed a clause that they should have paid attention to. One of our manufacturing clients lost 11 months in getting certification due to redesign and risk management remediation efforts. They missed fundamentals of the standard and had to remediate. Decisions in execution resulted in this delay
The detailed design decisions were cumbersome and burdensome for operations and did not take into account potential contingencies. Injection molding designs that could not be injection molded, often developed by junior industrial designers; There is often an obsession with making things as small as possible during design where it is not required so that they had no room for feature expansion for more circuitry or a larger battery so the molds for the housing needed to be redone for space and fitting a larger circuit board. I have seen parts fail incoming inspection because the tolerances are too tight for manufacturing. The drawings are over dimensioned so that incoming inspection is forced to inspect too many things. Part number / Revision change rules are not employed so incompatible configurations of parts are mixed up on the shop floor, so the operations team is forced to include revision in the part number leading to issues with all MRP systems and production errors.
The quality team implements inspection plans with little common sense in mind, often asking for over traceability and over inspection where not required.
Assembly documentation includes references to part numbers and revision so that wherever a change is made two things need to be updated the BOM and the work instruction resulting in two databases of the same information.
You pick parts suppliers from Alibaba, with unknown pedigree, a world away making it hard to fix supplier problems over the phone.
The design itself has a higher scrap rate because the parts assembled together don’t work when normal tolerances are encountered. Also, paint thickness if often ignored in tolerance stack up those leads to parts not fitting together and sanding of paint is required in production.
Do any of these items resonate with you? Or have you never heard of some of these?
The countermeasure to these issues is the use of Senior staff who have been at several design rodeos and know what to be worried to prevent delays. Who have systemic checklists of Standard work that meets regulation but is efficient.
For a design team to build a Design History File rapidly with the right amount of effort, ensure your team has one senior staff that understand how to do design and risk management documentation across the arc of the Design History file and is incharge of that. That they have a lean framework for requirements definition, risk control measure definition, and resulting verification and validation of the design that efficiently defines and verifies the design. The startup QA team must share in that vision or surrender faith that the vision will execute a viable Design History File that is defendable in an audit.
Your designers should be aware of the clauses of the safety standards but more importantly validate the applicable clauses early in the design with the 3rd party test houses like UL to ensure you have all the necessary clauses identified and accounted for in the design. Do this as soon as you have a hardware architecture and don’t hesitate to go back to them with changes. It will cost you to do this, but it will save you time in the end.
Detail design, detailed drawings, BOMS, measurement system analysis, traceability, inspection needs, part number control, assembly documentation and resilience to normal tolerances are all things that need to be considered in the design to ensure it is manufacturable and efficient to ensure lower manufacturing costs.. Ensure you have a good manufacturing engineer who can see the issues early in the design and help the design team protect for them and also help you to pick your suppliers wisely.
Strongly consider a senior development team with lots of experience to not only do the design, (the easy part) but do the documentation simpler, faster and auditable easily.
To do otherwise is to invite a world of pain and business risk to your company, your staff and your investors.
By Taras Worona, P.Eng, CEO and Director of Product development at Engineering CPR Inc
